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AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA

VATI AND GOMUTRA GHAN VATI IN SHWITRA


By,

Dr. BHAVIN KATHIRIYA. B.A.M.S.

Dissertation submitted to the Rajiv Gandhi University of Health Sciences Bangalore, Karnataka in partial fulfillment of the regulations for the award of the degree of AYURVEDA VACHASPATI DOCTOR OF MEDICINE (AYU) In KAYACHIKITSA GUIDE

Dr. SHRIDHARA HOLLA M.D. (AYU) Professor DEPT. OF P.G. STUDIES IN KAYACHIKITSA
CO-GUIDE

Dr. G. SRINIVASA ACHARYA M.D. (AYU) Professor & H.O.D S.D.M.C.A UDUPI.

DEPARTMENT OF POST GRADUATE STUDIES IN KAYACHIKITSA S. D. M. COLLEGE OF AYURVEDA, UDUPI 574 116 2012 2013

ACKNOWLEDGEMENT
In the very beginning I pray to the almighty God, who is all-pervading, omniscient and supreme. I offer my prayer to Lord Dhanwantari, the God of Ayurveda and add this small endeavor of my dissertation to the ever green knowledge of Ayurveda. Parents are the representatives of God on Earth. First and foremost I express my deep sense of gratitude to my parents Shri Chhaganbhai Kathiriya and Mrs. Hansaben Kathiriya; Dr. Vallabhbhai Kathiria(ex-Union Minister for Health and Family Welfare) and Mrs. Kantaben Kathiria; my wife Dr.Dinta; who all are the best advisors and criticizers of my career. If I could earn a drop of knowledge, it is solely because of their meticulous background and strapping moral support. It is indeed a privilege for me to express my profound gratefulness and gratitude to my esteemed guide Dr.V.K.Shridhara Holla. The present work couldnt have been completed without my revered teacher Dr. G. Srinivasa Acharya who also happened to be my Co-Guide.who has put the wealth of his ripe scholarship at my disposal that has carried me all the way in the correct direction in my study & research His constant guidance helped me fulfill this huge task. I also extend my respect to Dr. B. Ravishankar, Director Research Centre SDMCA who has given his valuable suggestions throughout my study. I am extremely thankful to Dr. U N. Prasad, Principal, SDM college of Ayurveda, Udupi for providing all the needed backgrounds for the successful and timely completion of my critique work. The teaching faculty of department of Kayachikitsa of SDMCA has supported me in every way. I would like to thank Dr. Jonah S, Dr. Shrilatha Kamath, Dr. Veerakumara, Dr. Aniruddha and Dr. Vijayendra Bhat. I pay my gratitude to Dr. Nagraj, Dr. P N Mogasale, Dr. Rajalakshmi, Dr.Gopikrishna and Dr Suma for providing me with regular inputs which helped me in completing my research. I convey my sincere thanks to Dr. Muralidhara, director of SDM Pharmacy for his help in arranging the material and making the medicine in time as well guidance and encouragement. VIII

I extend my sincere thanks to Dr. Navinchandra, Dr.Sunil and Miss Rajlexmi for valuable guidance in analytical studies. I pay my gratitude to Dr. K. B. Kathiria (Director of Research & Dean Anand Agriculture University) and Dr. P.G.Shah (Residue Analyst - Pesticide residue laboratory) for suggestion, guidance as well as invaluable help for providing analytical GS-MS report. I specially thank Dr Bachin for moral support and helping me in carrying out my research smoothly. At this moment I would also like to thank my colleagues Dr. Shailesh Acharya, Dr. Ramesh Gupta, Dr. Varun Joshi and Dr. Vijayendra for their support and Valuable Corporation throughout the completion of my thesis. I am also grateful to my seniors Dr. Nishanth Pai, Dr. Shrilatha Shetty, Dr.Gohar Vatsayan, Dr Ravikanth, Dr.Veeraj and Dr.Vasundhara for their supervision in all the academic activities. Nevertheless, the whole staff of SDM College & hospital deserves appreciation in helping me to complete this work. I am also grateful to my patients who accepted to be a part of this research without whom this work wouldnt have been completed. The feeling is so overwhelming that errors are bound to be. If amidst this I have failed to mention anyone, I assure that I have not forgotten him / her & the gratitude is most deeply felt.

Place: UDUPI Date:

DR. BHAVIN KATHIRIYA

IX

ABSTRACT
Objective:

To study combined therapeutic effect of Shashilekha Vati and Gomutra Ghana vati in patients suffering from Shwitra.

Design of Study:

An Open explanatory clinical study with pre test and post test design.

Settings:

SDM Hospital of Ayurveda, Udupi, Karnataka. From December 2011 to February 2013

Study Selection:

20 patients suffering from Shwitra of either sex were selected for the study.

Intervention:

Selected patients were treated with oral administration of Shashilekha vati in dose of 125mg tid (a.c.) with 10 ml Bakuchi Taila as anupana and Gomutra Ghana Vati 1 Gm tid (a.c.) and the same is continued for 56 days.

Main Outcome of Measures:

The response following the intervention was assessed every month by adapting the scoring method for colour, size, Number, percentage of Body area involved. Further the change observed by the completion of the treatment was subjected to paired t test to know the statistical significance.

Results:

The administration of Shashilekha Vati and Gomutra Ghana Vati proved to be effective in decreasing the severity of symptoms. The criteria Twaka Shwetata showed improvement in mean score which was 2.300 before treatment decreased to 0.6500 after treatment, the statistical test proved its significance. There was step down in mean score of Arun Varnata from 0.200 before treatment to 0.0500 after X

treatment, unraveling the significance. Tamra varna score before the treatment was 0.8500 came down to 0.2500 after treatment which proved its statistical significance. The severity of Twacha Ruksha showed improvement in mean score which before treatment was 1.300 decreased to 0.2000 after treatment, and it was statistically significant as proved by paired t test. Daha was reduced after administration of trial drug from mean score of 0.3000 to 0.0500 after treatment; the statistical test unraveled the significance. Roma vivarnata was reduced from mean score which was 0.4000 before treatment to 0.3000 w h ich proved the change in treatment is not greater than chance. Kandu score before the treatment was 0.300 came down to 0.150 after treatment which proved statistically not significance. The percentage of body area involved has showed statistically significant improvement as mean score before treatment which was 2.250 reduced to 1.250 after treatment. Number of Patches Score which was initially 2.450 decreased to 1.400 proving its significance statistically. The colour of patches was also statistically significant as Score before treatment which was 3.200 decreased to 0.850. Size of patches score which was 3.300 reduced to 1.600 proving the efficacy of the trial drug. Appearance of black spot over Shwitra patches showed statistically significant improvement as mean score before treatment which was 1.950 reduced to 0.300 after treatment. A Favorable response was observed in regards to all the symptoms.

Key Word: Shwitra, Gomutra Ghana Vati, Shashi Lekha Vati.

XI

LIST OF ABBREVIATIONS

A.H. A.S. AT a.c. B.P. B.R. B.S. BT C.D. C.S. Chi. DC DM ESR G.N. Hb H.S. HTN I.P.D K.S. M.N. No. O.P.D P Pu.kh R.R.S. S.D.M S.D S.E.M S.S. Sr.No.

Ashtanga Hridaya Ashtanga Sangraha After Treatment Ante Cibum Bhava Prakasha Bhaishajya Ratnavali Bhela Samhita Before Treatment Chakra Datta Charaka Samhita Chikistha sthana Differential Count Diabetes mellitus Erythrocyte Sedimentation Rate Gada Nigraha Haemoglobin Harita Samhita Hypertension In-Patient Department Kashyapa Samhita Madhava Nidana Number Out-Patient Department Probability Purva khanda Ras Ratna Sammuchaya Shri Dharmasthala Manjunatheshvara Standard Deviation Standard Error of Mean Sushruta Samhita Serial Number XII

Su. Tc t t.i.d Ut.kh VIDA Y.R.

Sutra Sthana Total Count t test Three times a day Uttara khanda Vitiligo disease activity score Yoga Ratnakar

XIII

LIST OF CONTENTS
Sl. NO. 1 2 3 INTRODUCTION OBJECTIVES REVIEW OF LITERATURE Chapter 1 -Twacha Rachna and Kriya Sharira Chapter 2 - Anatomy and Physiology of Skin Chapter 3 - Examination of Skin Chapter 4 - Historical Review Chapter 5 Nirukti Paribhasha Chapter 6 Paryaya Chapter 7 - Bheda Chapter 8 Nidana Chapter 9 - Purva Roopa- Roopa Chapter 10 Samprapti Chapter11 SapekshaNidana Chapter12 SadhyaAsadhyata Chapter13PathyaApathya Chapter14ChikitsaVivechanam Chapter15DrugReview 611 1220 21 2224 25 2627 2831 3242 4348 4956 CONTENTS

Page No.
14 5

57-58 59-60 61-62 63-72 73-85


86 8791

ANALYTICAL STUDY Chapter 1- HPTLC of Shashilekha Vati

XIV

Chapter 2 -Gas chromatographymass spectrometry (GCMS) of Shashilekha Vati and Gomutra Ghana Vati.
Chapter 3- Microbial load Analysis of Gomutra Ghana Vati

9296

9798 99105

Chapter 4- HPTLC of Gomutra Ghana Vati


5 METHODOLOGY Chapter 1- Material and Method Chapter 2- Observation 6 7 8 9 10 RESULTS DISCUSSION CONCLUSION SUMMARY BIBLIOGRAPHIC REFFERENCE ANNEXURE PROFORMA

106-113 114-139
140152 153164 165 166170 171184 IXI

XV

LIST OF TABLES
S.No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Name of Table Varnothpatthi based on combination of Pancha Mahabhutas Panchabhautikatva of Tvacha Layers of Tvacha according to Acharya Charaka Thickness of the Layers of Tvacha Layers of skin according to Sharangadhara Different Layers According To Different Acharya Layers of Tvacha according to Ayurveda and Modern Medicine Clinical criteria for classification of Vitiligo Etiological factors of Shwitra as per different classics Causes of localized hypopigmentation Samanya lakshana of Shwitra as per different classics Vishishta lakshana of Shwitra as per different classics Distinguishing features between shwitra and sidma Distinguishing features between kusta and Shwitra Differential diagnosis of vitiligo Shwitra sadhya asadhyata of Shwitra as per different classics Pathya in Shwitra Apathya in Shwitra List of drugs used internally and externally Showing Chemical description of cow urine and cure of diseases VIDA scoring Body Surface area using rule of 9 Distribution of Patients According to Age group Distribution of Patients According to gender Distribution According to Religion Distribution According to Educational Status Distribution of Patients According to Habitate Distribution According to Occupation Distribution According to Socio- Economic Status Distribution According to Marital Status Distribution of Patients According to Ahara Distribution According to Vyasana Distribution of Patients According to Prakruti
XVI

Page no. 7 7 8 8 9 9 10 30 36 42 45 46 57 57 58 60 61 62 67 81 109 111 115 116 117 118 119 120 121 122 123 124 125

34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58

Distribution of Patients According to Samhanana Distribution of Patients According to their Satva Distribution of Patients According to Satmya Distribution of Patients According to AharaAbhyavaharana and Jarana Shakti Occurrence of Symptoms of Shwitra Nidana of Shwitra identified in 20 Patients Manobhava identified in 20 Patients of Shwitra Showing incidence of Number of patches Shwitra Showing Incidence of Colour of patches Shwitra Showing Measurement of patches wise distribution of 20 cases of Shwitra Showing Chronicity wise distribution of 20 cases of Shwitra Showing Affected side wise distribution of 20 cases of Shwitra Showing VIDA SCORE wise distribution of 20 cases of Shwitra Effect on Twaka Shwethata Effect on Arun Varnata Effect on Tamra Varnata Effect on Twak Rukshta Effect on Daha Effect on Roma Vivarnata Effect on Kandu Effect on percentage of body involvement Effect on Number of patches Effect on colour of patches Effect on size of patches Effect on Black spots over shwitra patches

126 127 128 129 130 131 132 133 134 135 136 137 139 140 141 142 143 144 145 146 147 148 149 150 151

XVII

LIST OF FIGURES

S.No. 1 2 3 4 5

Name of Figure Ingredients of Shashilekha Vati Final Product - Shashilekha Vati Ingredients of Gomutra Ghana Vati Final product - Gomutra Ghana Vati Market Pack -Bakuchi Taila

Page No. 84 84 85 85 85

XVIII

LIST OF GRAPHS
S.No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Name of Table Distribution of Patients According to Age group Distribution of Patients According to gender Distribution According to Religion Distribution According to Educational Status Distribution of Patients According to Habitate Distribution According to Occupation Distribution According to Socio- Economic Status Distribution According to Marital Status Distribution of Patients According to Ahara Distribution According to Vyasana Distribution of Patients According to Prakruti Distribution of Patients According to Samhanana Distribution of Patients According to their Satva Distribution of Patients According to Satmya Distribution of Patients According to AharaAbhyavaharana and Jarana Shakti Occurrence of Symptoms of Shwitra Nidana of Shwitra identified in 20 Patients Manobhava identified in 20 Patients of Shwitra
Showing incidence of Number of patches Shwitra Showing Incidence of Colour of patches Shwitra Showing Measurement of patches wise distribution of 20 cases of Shwitra Showing Chronicity wise distribution of 20 cases of Shwitra Showing Affected side wise distribution of 20 cases of Shwitra Showing VIDA SCORE wise distribution of 20 cases of Shwitra

Page no. 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 138 139 140 141

Effect on Twaka Shwethata Effect on Arun Varnata

XIX

27 28 29 30 31 32 33 34 35 36

Effect on Tamra Varnata Effect on Twak Rukshta Effect on Daha Effect on Roma Vivarnata Effect on Kandu Effect on percentage of body involvement Effect on Number of patches Effect on colour of patches Effect on size of patches Effect on Black spots over shwitra patches

142 143 144 145 146 147 148 149 150 151

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Introduction

INTRODUCTION
Ayurveda since its inception accentuates more upon prevention of the disease and maintenance of health in healthy and alleviation of disease in ailing engulfing the mankind. In day to day clinical practice a general practitioner is confronted with versatile skin disorders. Few amongst them are easy to manage but remaining is complicated and intractable to manage, leading to cosmetic problems. In the present days as a sequel to modified life style, irregular dietary habits and genetic predisposition i.e. increased and indiscriminate use of Gara visha such as plastic, rubber, paints, perfumes and cosmetic materials of inferior quality, consumption of improper and incompatible food materials and related habits, intake of polluted water, usage of certain synthetic medicines, disinfectants, promiscuous use of pesticides have led to step up the incidence of dermatological disorders. The skin is one of the best revelation of general health. Even an amateur eye can detect any change in the skin. The colour and texture of the skin play a very important role to uphold ones personality even physical and psychological health. The skin has long been recognized as the organ of expression and serves as the boundary between ourselves and the outer world. The disease Shwitra is one which is contoured by colour variation in the skin and possesses a major cosmetic problem in the affected and may induct the subscript complex in him / her. Prima facie this disorder can be noted in dark skinned people. The affected people feel marooned from the society and get gloomy psychologically. Even our societies are also having a scornful opinion regarding this condition and try to isolate the affected people and hence this condition has a social stigma. Based on the symptoms Shwitra can be correlated with Vitiligo as told in modern science and classified under auto immune disorders1. It is an idiopathic hypopigmentory condition which affects about 1% of worlds population2. The exact cause of hypo pigmentation of the skin is unknown, but it is a condition which occurs due to the malformation and distribution of melanocytes and synthesis of melanin, a colouring pigment in the skin.

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Introduction

Shwitra is considered as one of the variety of Kushta. Even the causes of the Kushta are considered as same for this condition also. This disease of the dermis though benign may pose major cosmetic problem. The lesions of shwitra being dry and also non infectious, thus differs from the kushtha in general. The disease is characterized by invariable morbidity of all the three dosha afflicting rasa, rakta, twak and mamsa dhatu. The management of this condition is not completely satisfactory inspite of advances in conventional medicine which ranges from the application of corticosteroids and skin camouflage creams 3. In the Ayurveda counterpart, the shodhana and shamana treatment are said to be very effective. In classics we find various modalities of the treatment both externally and internally to treat this disorder and various works/ researches have been also carried out in this regard. Some of the examples are

In an open clinical study was carried out in 30 patients suffering from Kilasa. All selected patients were treated with Virechana karma by administering Trivruta Leha in therapeutic doses. This is followed by oral medication with Varnya maha kashaya as Shamana added with Avalguja beejadi churna as Aalepana. The treatment is continued for three months. The study recorded mild to excellent improvement in these patients4.

A comparative single blind clinical study was carried out on Shwitra, 38 patients were randomly allocated in three distinct groups in which the intervention included oral administration of Kakodumbara- Bakuchi compound for virechana karma along with external application of Karpanpatru oil. It was found that there was statistically significant reduction in the size, colour and number of the depigmented patches. The overall improvement recorded was 30 %5.

40 patients suffering from shwitra were subjected to double blind placebo control comparative clinical study in which the intervention included oral administration of non-bakuchi yoga such as Ankolakadi yoga capsule or Placebo capsule with external application of Ankolakadi lepa or placebo lepa. The study was conducted in randomly allocated four distinct groups. Study has revealed the
AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA 2

Introduction

involvement of psychological factor in shwitra, all the drugs shown highly significance effect on psychological factor of shwitra, where almost equivalent effect was observed for Hamilton anxiety scale. The group treated with medicine showed effective result compare to others.6

From the foregoing it is clear that shwitra is chronic distressing illness and complete remission of the illness is a big question with the available cumbersome treatment. Meagre numbers of different randomized clinical trials carried out in different centres are aimed at comparing the therapeutic efficacy of Shodhana and Shamana treatment along with Alepa either alone or in combination with moderate beneficial response. No clinical trials were carried out emphasizing the oral medication alone with special reference to Shwitra / Vitiligo. Keeping an eagle eye over shashilekha vati; a herb mineral formulation is described as an invaluable prescription in this disgusting disease and also herbal formulation containing gomutra is claimed to be an equally effective elite medication in the cure of the shwitra particularly Gomutrasava .Palatability was the main drawback against acceptance of Gomutrasava , so in the present study with the unique concept of Ghanakriya it was converted into Gomutra Ghana vati to rescue the issues related to adaptation of Gomutrasava. Hitherto a sincere effort has been made to evaluate a comprehensive formula on the subjects taken for clinical trial. The present study entitled An open explanatory clinical trial with a pre-test and post-test design evaluating combined therapeutic effect of Shashilekha Vati and Gomutra Ghan Vati in Shwitra was carried out with an aim to explore the combined therapeutic effect of Shashilekha vati and Gomutra Ghana vati on the activity of the disease in patients suffering from Shwitra.

The present study has been carried out in three parts; Conceptual Study, Analytical study and Clinical Study. Conceptual study includes disease review and drug review. Derivation of Shwitra is appear first in disease review followed with Nidana, Purvarupa, Rupa, Samprapti, Chikitsa, Pathya Apathya, Sadhya Asadhyata and Chikitsa. Drug review includes ingredients, dosage and method of preparation of medicine. Analytical study includes Microbial load analysis of Gomutra Ghana vati, HPTLC fingerprinting of Gomutra Ghana vati, HPTLC fingerprinting of Shashilekha
AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA 3

Introduction

vati and Gas chromatography mass spectrometry of Gomutraghana vati and Shashilekha vati. Prima Facie;for clinical study 20 diagnosed case of Shwitra were taken. Each patient was given with Shashilekha vati 125mg tid with 10ml of Bakuchi Taila as anupana before food and Gomutra Ghana Vati 1 gm tid before food for 56 days. Patients were assessed in terms of pratyatma lakshana of Shwitra and VIDA score. The third part of the study contains Methodology, Results, Discussion, Conclusion and Summary.

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Objectives of the study

OBJECTIVES OF THE STUDY

1. To study nidana panchaka of Shwitra according to Ayurvedic texts in detail. 2. To Rectify and study literature for the different clinical aspects of Shwitra in ayurveda and Vitiligo in Modern medicine for critical analysis in detail. 3. To assess the role of Shashilekha vati along with Gomutra Ghana vati internally in Shwitra.

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Tvacha rachana and Kriya Shareera

TVACHA RACHANA AND KRIYA SHAREERA

Definition: Twacha is one of the Indriyadhisthana; which is derived from TvachSamvarne Dhatu which literary means completely covering of Meda, Shonita and all

other Dhatu of the body and spreads all over the body7. It is considered as the seat of Sparshanendriya as well as one among the main seat of Vata8, 9.

Formation of Tvacha: According to Acharya Charaka, Tvacha is the Upadhatu of Mamsa, so ultimately Tvacha is formed by Mamsa10 and it is also a Matrujabhava because it is coming through ovum 11. According to Acharya Vagbhata, Tvacha is formed by the Paka of Rakta Dhatu by its Dhatvagni. After the Paka of Rakta by its Dhatvagni, Rakta become dry in the form of skin like the deposition of cream on the surface of the boiling milk. Thus, Tvacha is also called as Rakta Santanika12 According to Acharya Sushruta, Tvacha develops after the fertilization of the ovum. At the time of fertilization, Shukra, Shonita and Jeeva become united for the formation of Garbha. Its growth is rapid and nourished by Tridosha. Seven layers of the Tvacha are formed and deposited on this rapid transforming product in the same manner as the layers of cream are formed and precipitated on the surface of the boiling milk13.

Varnotpattikarana in garbha:
The complexion does not depend only on karma but it depends on the Tejo mahabhuta. Different complexions arise on the basis of association of Tejomahabhuta with other mahabhuta14. Astanga Sangrahakara mentioned causes of Varnotpatti as follows, 1) The garbha attains shukla Varna if shukra has the colour of ghrutha manda; The garbha attains goura varna if shukra is of taila Varna; The garbha attains Krishna Varna if shukra is like madhu. 2) The colour of garbha depends on ahara taken by garbhini. The garbha attains goura varna if she consumes madhuradravya; The garbha attains krishnavarna if

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Tvacha rachana and Kriya Shareera


she consumes vidahi padartha ; if she consumes the combination of madhura and vidahi padartha garbha attains shyama Varna. 3) Varna depends on desha, kala and anuvrutti (mode of living) 15.

4) Hareetha explained varnotpathi on the basis of doshas16.


Table 1: Varnothpatthi based on combination of Pancha Mahabhuta Varna Gaura C.S / A.S Teja + Jala + Akasha Krishna Teja + Pruthvi + Vayu Shyama All mahabhutas in equal proportion Gaurashyama -Teja + Jala + Akasha Krishnashyama -Teja + Pruthvi + akasha Pingala --Pitta + Raktha --Vata + Kapha and Raktha + Kapha -Teja + Pruthvi Vata + Raktha S.S Teja + Jala H.S Pitta

Panchabhautikatva of Tvacha: All the organs are made of Panchamahabhuta17. So Tvacha should have a Panchabhautika constitution. Tvacha being a Dravya, its Panchabhautika constitution can be understood as follows

Table No 2: Panchabhautikatva of Tvacha: Mahabhuta 1) Prithvi Effect Tvacha has been considered as the Upadhatu of Mamsa Dhatu that shows it is stable, which is an innate quality of Prithvi. 2) 3) 4) 5) Jala Agni Vayu Akasha Due to the presence of Jala Mahabhuta, Tvacha is Snigdha. Tvacha has the specific Varna and luster. Tvacha is the Adhisthana of Sparshanendirya. Presence of some micro channels of Sweda forming organs.

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Tvacha rachana and Kriya Shareera Layers of Tvacha: There are some different opinions regarding the number of the layers of the Tvacha among the ancient Acharya. Acharya Charaka has mentioned six layers of skin but only first two layers are named and rest of the four layers are counted as producing diseases18. Table No 3: Layers of Tvacha according to Acharya Charaka: Layer Udakadhara Ashrukadhara 3rd 4th 5th 6th Contains Udaka means watery substance or lymph Blood capillaries Manifestation of Sidhma and Kilasa Manifestation of Dadru and Kushta Manifestation of Alaji and Vidradhi Manifestation of Arunshi. If this layer is injured then the individual gets trembled and enters in to the darkness. Acharya Sushruta has mentioned seven layers of tvacha along with their specific name, thickness and prone origination of the disease19.

Table No 4: Thickness of the Layers of Tvacha:

Sl. No

Layers

Thickness Ancient (in Vreehi) Modern (mm) 0.05 0.06 0.06 0.07 0.08 0.09 0.12 0.15 0.20 0.50 1.00 1.10 2.00 2.10

Reflection of disease

1 2 3 4 5 6 7

Avabhasini Lohita Shweta Tamra Vedini Rohini Mamsadhara

1/18 1/16 1/12 1/8 1/5 01 02

Sidhma, Padmini, Kantaka Tilkalaka, Vyanga, Nyachha Charmadala, Ajagallika, Mashaka Kilasa, Kushta Kushta, Visarpa Granthi, Apachi, Arbuda, Sleepada, Galaganda. Bhagandara, Vidradhi, Arsha

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Tvacha rachana and Kriya Shareera Acharya Vagbhata has also described seven layers of skin but names are not mentioned. Commenting on Acharya Vagbhata, commentator Arundatta and Hemadri have named them according to nomenclature given by Sushruta20.

Sharngadhara has also mentioned seven layers of the skin along with the probable onset of disease. The name of first six layers is as same as Sushruta but 7th layer is called Sthula, which is the site of Vidradhi21.
Table 5: Layers of skin according to Sharangadhara Name Avabhasini Lohita Shweta Tamra Vedini Rohini Sthula (2 vreehi) Diseases Sidhma Tilakalaka Charmadala Kilasa & Shvitra All types of Kushtha Granthi,Galaganda, Apachi Vidradhi

Gangadhara has clarified the difference in opinion between Charaka and Sushruta on the basis of the different opinions regarding the layers of Tvacha. He explains that the third layer of Charaka is to be counted as two parts superficial and deep. The superficial part is considered as third layer (Shweta) while the deep part as a fourth layer (Tamra) as mentioned by Sushruta22.

Table No 6: Different Layers According To Different Acharya: Sushruta Avabhasini Lohita Shweta Tamra Vedini Rohini Mamsadhara Charaka Udakadhara Asrukdhara 3rd 4th 5th 6th Arunadatta Bhasini Lohita Shweta Tamra Vedini Rohini Mamsadhara Sharngadhara Avabhasini Lohita Shweta Tamra Vedini Rohini Sthula
9

Bhela Udakdhara Asrikdhara 3rd 4th 5th 6th

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Tvacha rachana and Kriya Shareera Thus fundamentally there is no difference in the number of layers said by various Acharya. Dr.BG.Ghanekar has correlated the layers of the skin described by Sushruta and modern anatomy.

Table No 7: Layers of Tvacha according to Ayurveda and Modern Medicine: Ancient Term Avabhasini Lohita Shweta Tamra Vedini Rohini Mamsadhara Modern Term Stratum Corneum Stratum Lucidum Stratum Granulosum Malpighian layer Papillary layer Reticular layer Subcutaneous tissue and Muscular layer Dermis Epidermis Parts of Skin

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

10

Tvacha rachana and Kriya Shareera TVACHA KRIYA SHAREERA

Relation between Tvacha and Dosha: Skin has been considered as Sparshanendriya Adhishtana23 which is controlled by Pranavata among the five types of Vata. Udana Vata maintains the varna24. Bhrajaka Pitta is located in the Tvacha for giving luster and colour25.
Arunadutta comments as the Pitta located in the skin is designated as Bhrajakagni and is responsible for digestion and absorption of the substances used for Abhyanga, Parisheka, Avagaha and Lepa. The Bhrajaka Pitta located in Tvak manifests the colour in Avabhasini layer26.

Snigdhata, Shlakshnata, Mruduta, Sthirata, Sheetata, Prasannata, Snigdha Varnata are the attributed to Kapha. For Ropana Karma (self-healing process) Kapha is responsible factor.

Tvacha and Dhatu: Rasa: In the context of Twak Sara Purusha Lakshana it has been also said as Rasa Sara. 1st layer of Tvacha, the Udakadhara also contains Rasa (lymph). So, it can be easily understood that there is a relation between Tvacha and Rasa. Rakta: Among its functions of Rakta, Varna Prasadhana (impart colour to the skin) and Mamsa Pushti have been mentioned27. Mamsa: Twak is upadhatu of Mamsa28. Tvacha and Mala: Sweda: It is Mala of Meda which is excreted by Tvacha. Sweda maintains the luster and humidity of skin29. Nakha and Loma are Mala of Asthi Dhatu and Twakgata Sneha is the Mala of Majja Dhatu30.

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Anatomy of Skin

ANATOMY OF SKIN 31
The skin is the largest organ of the body accounting for 16-20% of its weight. It is not just a covering of the rest of the systems of the body but is a system by itself. Without proper functioning of the skin it is not possible to live. The skin performs some vital functions. It is a protective barrier between the body and the external environment. It protects the body from mechanical and chemical injuries, microbial organism and solar radiation. It also prevents undue loss of fluid and electrolytes. It helps maintain the constancy of the body temperature. Sensation of touch, pain, temperature, vibration, itching is felt by the sensory nerve fibers located in the skin. In adults the skin covers area of about 2 square meters (22 Sq. ft.) and weight 4.5 5 kg; its thickness is about 0.5 to 4 mm depending upon the location.

Embryology: All the constituents of human skin are derived from either endoderm or mesoderm. 1. The epithelial structures i.e. epidermis, pilosebaceous apocrine units, Eccrine sweat unit and nail units are Ectodermal derivations. 2. Melanocytes, neuroectoderm. 3. The other elements in the skin i.e. Longerhans cells, Macrophages, Mast cells, Fibroblast, Blood vessels, Lymph vessels, Muscles and Lipocytes are originated from the mesoderm. Micro-Anatomy of Skin: Structurally, the skin consists of two principle parts. a. The superficial inner portion, which is composed of epithelial tissue, is called the Epidermis. b. The Epidermis is attached to the deeper thicker connective tissue part is called the Dermis. Deep to the Dermis there is a subcutaneous layer, which is called the superficial fascia or Hypodermis contents of which are areola and adipose tissue. Nerves and specialized sensory receptors arise from

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Anatomy of Skin A. Epidermis: The Epidermis is defined as a stratified squamous epithelium, which is about 0.1mm thick although the thickness is greater up to 0.8 to 1.4mm on the palm and sole. Its prime function is to act as a protective barrier. The main cell of the epidermis is Keratinocyte, which produces the protein Keratin. The four layers of the epidermis represent the stages of maturation of keratin by Keratinocytes. i. ii. iii. iv. 1. Stratum Basale: The basal cell layer of the epidermis is comprised mostly of keratinocytes which are either dividing or non-dividing. The cell contains keratintonofibrils and is secured to the basement membrane by Hemidesmosomes. Melanocytes make up 510% of the Basal cell population. These cells synthesize melanin and transfer it via dendritic process to neighboring keratinocytes. Melanocytes are most numerous on the face, other exposed sites and are neural crust origin. Merkel cells are also found albeit infrequently in the basal cell layer. These cells are closely associated with terminal filaments of cutaneous nerve and seem to have role in sensation. Their cytoplasm contains neuropepataide granules as well as neurophylaments and Keratin. 2. Stratum Spinosum: Daughter Basel cells migrate upwards to form this layer of polyhedral cells which are interconnected desmosomes. Keratintonofibrils form a supportive mesh in the cytoplasm of these cells. Langerhans cells are found mostly in this layer these enteritis immunologically active cells are described ahead. 3. Stratum Granulosum: Cells become flattened and lose their nuclei in the granular cell layer. Keratohylin granules are seen in the cytoplasm together with membrane-coating granules, which expel their lipid contents into the intercellular spaces. Basal layer (Stratum Basale) Prickle cell layer (Stratum spinosum) Granular layer (Stratum granulosum) Horny layer (Stratum corneum)

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Anatomy of Skin 4. Stratum Corneum: The end result of Keratinocyte maturation can be found in the horny layer, which is, comprised sheets of overlapping polyhedral cornfield cells with no nuclei (coenocytes). The layer is several cells thick on the palms and soles, but less thick else where. The corncocyte cell envelope is broadened and the cytoplasm is replaced by keratintonofibrils in a matrix formed from the Keratohylin granules cells are stuck together by a lipid glue which is partly derived from membrane coating granules. B. Dermis: The dermis is defined as a tough supportive connective tissue matrix containing specialize structure found immediately below and immediately connected with the epidermis. It varies in thickness being thin 0.6 mm on the eyelids and thicker more than 3 mm on back, palms and soles. The papillary dermis - the thin upper layer of dermis - lies bellow and inter digitizes with the epidermal ret ridge. It is composed of loosely interwoven collagen coarser and horizontally running bundles of collagen are found in the deeper and thicker reticular dermis. Collagen fibers make up 70% of the dermis and impart a toughness and strength to the structure. Elastic fibers are loosely arranged in all directions and provide elasticity to the skin. They are numerous near hair follicles, sweat glands and less so in the papillary dermis. The ground substance of the dermis is a semi solid matrix of Glycosaminoglycans (G.A.G), which allows dermal structures some movement. The dermis contains Fibroblasts, Dermaldendrocytes, Mastcells, Macrophages and lymphocytes.

Subcutaneous layer: The subcutaneous layer consists of loose connective tissue and fat, which is up to 3cm thick on the abdomen.

Derivatives of the Skin: Organs that develop from the embryonic epidermis have been considered as derivatives of the skin. They are Hair Nails Sebaceous glands Sweat glands 14

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Anatomy of Skin Hair: Hairs are found over the entire surface of the skin with exception of glabrous skin of the palm, Soles, Glans penis and Vulval introits. The density of follicles is greatest on the face. Embryologically the hair follicle has been in put from the epidermis, which is responsible for the matrix cell, the hair shaft and the dermis, which contributes the papilla with the Blood vessels and Nerves. There are three types of hair.

Lanugo: These hairs are fine and long, they are formed in the foetus at 20 weeks gestation. They are normally shed before birth but may be seen in premature babies.

Vellus: These hairs are short, fine light coloured hair that covers the most body surface. Terminal: These hairs are longer, thicker and darker. They are found on the scalp, Eyebrows, Eyelashes, also on the pubic, axillar and beard areas. They originate as Vellus hair; differentiation is stimulated by puberty by androgens.

Structure of Hair: The hair shaft consists of an outer cuticle, which encloses a cortex of packed keratinocytes with an inner medulla. The germinative cells are in the hair bulb melanocytes are associated with these cells, to synthesize pigment. The erector pile muscle is vestigial in man and it contracts to erect the hair producing goose pimples.

Nails: The nails are a phylogenetic remnant of the mammalian claw and consist of a plate of hardened and densely packed keratin. It protects the finger and facilitates grasping and tactile sensitivity in the finger pulp.

Structure of Nail: The nail matrix contains dividing cells which are the mature keratinize and more forward to form the nail plate. The nail plate has a thickness of 0.3 to 0.5 mm AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE
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Anatomy of Skin and growth rate of 0.1 mm/24hr, for the fingernail. Toe nails grow more slowly, the nail bed which produces small amounts of keratin is adherent to the nail plate. The adjacent dermal capillaries produce the pink colour of the nail. The white lunula is the visible distal part of the nail. The Hyponychium is the thickened epidermis, which under lays the free margin of the nail.

Sebaceous Glands: Sebaceous glands are found associated with hair follicles especially those of the scalp, face, chest, and back. They are not found on non-hairy skin. They are formed from epidermis and produce an oily sebum. The function of sebum is uncertain. The glands are small in the child but become large and active at the age of puberty, being sensitive to androgens sebum is produced by Holocrine secretion in which the cells are disintegrating to release their lipid cytoplasm.

Sweat Glands: Sweat glands are tube like and coiled glands located with the dermis, which produce a watery secretion. These are two separate types. i. ii. Eccrine glands Apocrine glands

1. Eccrine Glands: Eccrine glands develop from down building of the epidermis. The secretary portion is a coiled structure in the deep reticular dermis. The excretory duct spirals upwards to open in to the skin surface. An estimated 2.5 million sweat ducts are present in the skin surface. They are universally distributed but are most profuse on the palm, soles, axillae and forehead where the glands are under both psychological and thermal control. Eccrine sweat glands are innervated by sympathetic (cholinergic) nerve fibers.

2. Apocrine Glands: These glands are also derived from the epidermis and open in to hair follicles. These glands are larger than Eccrine glands. They are most numerous around the axillae perineum and areole. There sweat is generated by Decapitation secretion of

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Anatomy of Skin the gland cell is odor less when produced but an odor develops after skin bacteria have acted upon it. Sweating is controlled by sympathetic (Adrenergic) innervation.

PHYSIOLOGY OF THE SKIN The skin is a metabolically active organ with vital functions including the protection and homeostatic of the body. Regulation of body temperature: The skin does the evaporation of sweat and convert high temperature into lower elevated body temperature or to the normal vise a versa. Changes in the low of blood to the skin also help the regulation of body temperature. Protection: The skin is considered under integumentary system. It provides physical barrier that protect the underlying tissue from physical abrasion, bacterial invasion, dehydration and U.V Radiation. Sensation: The skin contains abundant nerve ending and receptors that detect stimuli related to temperatures, touch, pressure and pain. Immunity: Sweat of the epidermal cells is important components of the skin immune system, which fends off foreign invaders. Excretion: Sweat is the vehicle for loss of a small quantity of irons and several organic compounds along with removal of heat and some part of water. Blood reservoir: The dermis is a house of extensive networks of blood vessels that carry 8-10% of the total blood flow in a resting adult. In moderate exercise this flow increase, which helps to dissipate the heat from the body. While during the exercise skin blood vessels constrict so this allows more blood to circulate through contracting muscles. Synthesis of vitamin-D: Vitamin-D is a group of closely related compound. Synthesis of Vitamin-D begins with activation of precursor molecule in the skin by U.V rays in the sunlight. AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE
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Anatomy of Skin Enzymes in the liver and kidneys then modify this molecule and producing Calcitrol, the most active form of vitamin-D. Calcitrol is essential for the homeostasis of body fluids by aiding absorption of calcium in foods from digestive tract in to the blood. Thus the skin is considered as an endocrine organ, which secretes Vita-D hormones, which produce in the one part of the body, transported by the blood and exert its effects in other locations. Keratin Maturation: The differentiation of Basel cells in to dead, but functionally important, coenocyte is a unique feature of the skin. The horney layer is important in preventing all manner of agents form entering the skin including microorganisms, water and particulate matter. The epidermis also prevents the body fluids from getting out. Epidermal cells undergo the following sequence during keratinocyte maturation. Undifferentiated cells in the Basel layer and the layer immediately above divide continuously. Half of these cells remain, in place and half progress upwards and differentiate. In the prickle cell layer cells change from being columnar to polygonal. Differentiating keratinocytes synthesize keratin, which aggregate to form tonofilaments. The desmosomes connecting keratinocytes are condensations of tonofilaments. Desmosomes distribute structural stresses throughout the epidermis and maintain a distance of 20mm between adjacent cells. In the granular layer enzymes induce degradation of nuclei and organelles. Keratohyalin granules mature the keratin and provide an amorphous protein matrix for the tonofilaments. Membrane coating granules attach to the cell membrane and release an impervious lipid containing cement which contributes to cell adhesion and to the horney layer. In the horney layer the dead flattened corneocytes have developed thickened cell envelops encasing a matrix of keratin tonofibrils. The strong disulfide bonds of the keratin provide strength to the stratum corneum but the layer is also flexible and can absorbs up to 3 times its own weight in water, however if it dries out water content falls bellow 10% pliability fails. The corneocytes are eventually shed from the skin surface.

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Anatomy of Skin Rate of Maturation: Kinetic studies show that on average the dividing basal cells replicate every 200-400 hours and the resultant differentiating cells takes about 14 days to reach Stratum corneum and a further 14 days to be shed. The cell turn over time is considerably shortened in keritinization disorders such as Psoriasis. Biochemistry of the Skin: The important molecules synthesized by the skin include keratin, melanin collagen and Glycosaminoglycans. Keratin: These are high molecular eight polypeptide chains produced by keratinocytes. They are the major constituent of stratum corneum (65%), hair and nails. Keratin polypeptides are to different molecular weight (e.r. 50,55,57,67 etc) and different keratins are found at each level of epidermis depending upon the stage of differentiation. Epidermal keratin contains less cystine and more clycine then the harder hair keratin. Melanin: It is produced from tyrosine in melanocytes and takes two forms. 1. 2. Eumelanin: Which is more common and gives a brown black colour. Phacomelanin: Which is less common and produces yellow or red colour. Most natural melanins are mixtures of Eumelanin and phacomelanin. Melanin act as an energy sink and free radical scavengers and absorbs the energy of UV radiation. Collagen: It is synthesized by fibroblasts and is the major structural protein of the dermis forming 70-80% of its dry weight. The main amino acid collagens are Glycine, proline and Hydroxyproline. There is over 14 types of collagen at least 5 of which are found in the skin. Type I Type II It is found in Reticular dermis. It is found in papillary dermis. It is found in the basement membrane structures. It is found in the endothelial cells.

Type III & IV Type V -

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Anatomy of Skin Glycosaminoglycan (GAG): The Ground substance of skin is largely made up GAGs of providing viscosity up hydration. In the dermis Chondroitin Sulfate is the main GAG along with Dermatansulphate and Hyaluronan. GAGs often exists as high molecular weight polymers with a protein core. It is known as Proteoglycans. Hormones and the Skin: The skin is the site of production of one hormone (vitamin-D) but it is often a target organ for other hormone and is frequently affected in endocrine diseases.

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Examination of the skin

EXAMINATION OF THE SKIN


Examination of skin plays very important role in the diagnosis of Shwitra. Examination is carried as follows. Inspection: By inspection following factors are to be noted. a) Distribution and arrangement of the patch- Areas where patch is located is noted and whether the patch is generalized or localized, whether the patches are symmetrical or asymmetrical and where exactly the patches are present like over exposed area scalp region, hand, extensor or flexor aspect etc. b) Morphology of the patch By naked eye examination also morphology can be explained. If patch is early primary lesion the help of magnifying glass is needed. Shape and size- These factors are noted as the shape of the patch is oval or irregular or rectangular and size of the individual patch is measured. Colour- It is very important factor whether the patch is pure white, erythematous or pinkish. In Ayurvedic view, the colour of the patch depending upon doshic involvement is noted like arunavarna, tamravarna, shwetavarna. Margin Margin of the patch is inspected to know whether it is hyper pigmented or inflamed regular or irregular.

Palpation: This pareeksha is carried out to know about the rooksha, snigdha etc qualities of the patch, that is to say the texture of the patch and local temperature of the patch and to see any elevation in the patch. Tests to know about the sensation of the patchs are very important which is done as follows. I. Pin and Needle prick Test: This test is done to know the deep and superficial pain sensation. II. Hot and Cold touch Test: This is to test the hot and cold sensation in the patch.

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Conceptual study

Historical review

HISTORICAL REVIEW
Specific advances in a science happen with the culmination of knowledge from different scholars over a period of time. New observations are added and older ones lose their relevance. Ayurveda also developed on the same principles with the passage of time. Comprehensible searches within the Ayurvedic literature and the present day annotations also unveil the gradual and progressive understanding of shwitra. Thus, it becomes necessary to discuss the history of shwitra which will help us to understand the Ahara-Vihara, traditions, culture, ways of living and other diseases prevailing at that time which also influenced its manifestations.

VEDIC PERIOD : (2500BC-1000BC) The Veda establishes many elusive links with the charms and hymns. Valuable sources of information for understanding the disease Shwitra are encapsulated in the literature of many epochs such as Rigveda, Samveda, Yajurveda and Atharvaveda which are four popular Veda. In Rigveda the word Switra was used, but it is entirely in different context.This is used for land which probably means earth but not for vitiligo32 .Other relevant reference regarding Shwitra is found as Shweta Kustha which is mentioned in a Story of Ghosha, the daughter of Kakshavati was declined by her husband when Shweta Kushta imposed her. Ashwini kumaras, the pioneers in medical profession treated and cured her from Shveta Kushtha and restored her youth and beauty, which made to regain her marital status33. In Rigveda, Kilasa is the word used to describe the white spotted deer, which has striking resemblance with the disease Shwitra where the hypopigmentary patches are diffused over the body without ulcers34. In Atharvaveda the term like Kilasa, Palita are used in place of Shwitra35. In Koushika Sutra of Atharvaveda Rama, Krishna, Asikri are the medicinal herbs described as the remedy for the malady Kilasa and Khalitya. A commentator also mentioned Bhringaraja, Indravaruni and Neeli are the drugs described as the drugs Rama, Krishna and Asikri respectively. The fourth drug procured in maintenance of the color is Rajani or Turmeric35.
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Conceptual study

Historical review

In Yajurveda there is a reference mentioning that Chandra (moon) is affected with the disease kilasa36. According to Taittariya Brahmana, the students suffering from the following diseases were not acceptable by the guru. Switri chaiva galatkust inetrarogi cha vamane kunakha shyavadantavascha Sama veada probably has no reference of Shwitra. Reference of Shwitra is also found in Panini vyakarana sutra37.

Purana:
They are 13 in number. Purana were mainly concerned with the history of evolution of the universe including karmakand and Dharmshastra. In various purana nothing in particular about Shwitra has been said except in Garuda purana. In Garuda purana it is said etiological factors of Shwitra and Kushtha are considered to be the same. In some chapters of Agni purana Kushtha and its treatment is mentioned.

MANU SMRITI: Kushta is differentiated from Shwitra and considered as a serious problem. There is a reference stating that the Persons who suffer from Shwitra; their progeny are disqualified for wedlock38. MAHABHARATA: During this period person who is suffering from Tvaka dosha is unfit to become a king. Inspite of that Pandu was said to be suffering from Shvitra, he claimed to rule Hasthinapur.

Samhita Period(1000BC-100AD): Samhita period is considered as golden epoch of Ayurveda as maximum contribution is given in this period. Acharya Charaka introduced Shwitra roga with Kushta chikitsa adhyaya, specified its dhatugatatwa up to medodhatu and also emphasised about its specific nidana39. Acharya Sushruta also mentioned about shwitrarog in kushtarogadhyaya and dealt its types as Vataja, Pittaja and Kaphaja Shwitra along with its sadhyasadhyata40.

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Conceptual study

Historical review

In Dalhana commentary of Nidanasthana Bhojas opinion on types of Shvitra is mentioned41. Acharya Bhela has also described Shwitra in brief42. In Harita Samhita Pandura Kusta Chikitsa is mentioned, which is similar to Shwitra Chikitsa43. Kashyapa Samhita has also dealt about Shwitra in Kustha chapter itself 44 and defined its cardinal symptom as twacha Shwetata due to vitiation of Tvakgata Udaka45.

Sangraha Period (800AD-1700AD): Important works of this period are Ashtanga Sangraha, Astanga Hridaya, Madhava Nidana, Bhava Prakash, Sharangadhara Samhita and Yoga Ratnakar. These books compiled and reproduced the scattered information of Samhita in an order. In Astanga Sangraha savisha jaloukavacharana is specially mentioned as causative factor46. Acharya Sharangadhara has given numerical data on Shwitra and its remedy.

Adhunika Kala (1700AD): This started after the entrance of the foreigners. Here especially during recent decades there has been tremendous and marvellous development in the field of medicine. Becker and Obermayor reported Vitiligo cases in 1937 and Bubkley and Lobitz in 1953. Afterwards A. B. Lener (1959), Fitz Patric (1974), Parish J.A (1976), P. N. Behl (1980) and Roburghi (1980) have done in depth studies on vitiligo.

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Nirukti/Paribhasha

NIRUKTI/PARIBHASHA The naming of a disease in Ayurveda is based on many factors. The involved dosha, dushya, affected site and also the chief symptom play a major role in deciding the nomenclature of the disease. Along with shwitra, many other diseases like Visarpa and Koshthuk-shirsha have been named on the basis of features or analogy. As understood, the term shwitra is derived from two words, Shweta and Rak. To be precise, it is the involvement of skin which leads manifestation of whitish depigmentation.

Nirukti ( Shwitra ) When root Shwith and suffix RIK; these two are mixed as a rule KA is deleted. Thus becomes as Shwitra47. SWITH + RIK + KA SHWITRA Shwitra which broadly mean Shweta Varna i.e. white colour

Paribhasa ( Shwitra ) Shabda Kalpadruma vindicated as : Swetate iti Shwitram48 Which explains as Shwitra is a ailment where whitish discoloration of the skin is a spectacular symptom. Kasyapa samhita also gives an alike definition: Shweta bhavamicchanti Shwitram49 Shwitra is a disease where whitish colouration of the skin i.e. which imparts white colouration to the skin. Vitiligo ( Etymology )50 The origin of the term vitiligo is obscure like the disease itself. Some believe that it is from the Latin word vitellus means vale that is pale pink flesh of a calf, while others tell that its from the word vitium means blemish (pale). It is an idiopathic, acquired, localized or disseminated depigmentation of the skin, vitiligo, which though worldwide in distribution, is most common in India, Egypt and other tropical countries. Incidence of this disease is about 1-2% of the world population.
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Paryaya

Paryaya:

Prima facie the synonyms of Shwitra, implicitly present a typical picture of Shwitra, in relation to different signs and symptoms. 1. Kusta 2. Shwetha kusta 3. Kilasa 1) Kushta51: In general it implies to most of all the skin disorder as because Shwitra is also one of the skin disorder it is named as kusta 4. Charuna 5. Daruna 6. Varuna

2) Shwetha kushta : Shwetataa anena iti shwetha kustam52 According to Amarakosha, it is considered as one of the synonyms of Shwitra. Shwetha means white and kusta means skin disorder. It imparts meaning the disease characterized by the whitish colouration of the skin is known as Shweth kusta.

3) Kilasa: Kila means discoloration i.e. white and Asa is suffix which means to vitiate or to trough out or to carry form. Thus Kilasa means white colored pigment vitiatation of the skin Shabda kalpa drum defines as : Kil varnam yasyati kshiyati vikruti karoti (yat) iti Kilasa53 The Condition which exhibits whitish colour distinguishable vitiation of skin is known as kilasa.

Kashyapa has considered this as one of the synonyms of the Shwitra. Chandramase kilasam54 Kilasa is one of the synonyms of chandrama or moon in Yajurveda. Hence the disease which is characterized by the colour of the moon (Shwetha) is known as kilasa.

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Paryaya

4) Charuna / Aruna: Panini vindicates root RU and suffix UNAM are mixed and become as Aruna. Ru + Unam = Aruna The term Cahruna, is composed with Cha + Aruna, which indicate the color of the patches. The colour of patches those are found in this disease are similar to colour of rising sun or Reddish brown i.e. the dawn. 5) Daruna: Panini explains the term Daruna is composed of Dra + Nich +Unan = Daruna Which literary means fearful appearance of the patient.A condition which creates the fear in the mind is called Daruna. The white patches on skin categorically look alike frightful and ugly. The term may also indicate chronic and severe nature of the disease. Vagabhata also said that this ailment is worse and stigmatic then Kushtha55 6) Varuna : Panini vindicates root VRU and suffix UNAM are mixed and become as Varuna. Vru + Unam =Varuna Bhaluki has substitute the term Aruna by Varuna and he said that Mansagata Kilasa is Varuna. The term Varuna has been coined by Bhaluki as refer by Shreekanthdutta in his commentary. The Shwitra which inflicts due to sinful act results into unpleasant outlook of the Person; so he imposes himself to isolate from the society due to stigma. The term reflects psychological part of the diseases; it can be somato-psychic disorder. Here the involvement of psyche occurs in later stage of the disease Synonyms: 1. Vitiligo : Depigmented or Hypopigmented patches that result from absence or reduction of melanocytes due to unknown cause. 2. Leukoderma : Term is applied for depigmented patches of known cause like burns, contact with chemicals like phenols or following an inflammatory skin disease.
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Bheda

Bheda: Bheda is a part of Sankhya Samprapti 1. According to Ashraya: (cha. Chi. 7th )56 (A) Raktasrita Shwitra (B) Mamsasrita Shwitra (C) Medoasrita Shwitra 2. According to Dosha; (As. San. Ni. 14th)57 (A) Vataja Shwitra (B) Pittaja Shwitra (C) Kaphaja Shwitra 3. According to Nidana: (M.N. 49/39 commentary)58 A- (a) Doshaja Shwitra: (1) Atmaja - caused by Vata, Pitta or Rakta and Kapha (2) Paraja - caused by Paragatra Sparsha. (b) Vranaja Shwitra : caused by Vrana B- According to Sushruta: (Su. Ni. 5/27)59 (a) Sahaja (b) Jatothara 4. According to Prognosis: (a) Sadhya Shwitra (b) Asadhya Shwitra 5. According to Colour: (a) Raktavarna Shwitra (b) Tamravarna Shwitra (c) Swetavarna Shwitra 6. According to Vagbhata: (As. San. Chi. 22/11 indu)60 (a) Garbhaja Shwitra

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Bheda

Classification: Depending upon the distribution vitiligo can be clinically differentiated in the following types: (a) Focal Vitiligo (b) Segmental Vitiligo (c) Generalized Vitiligo (d) Acroficial Vitiligo Localized Vitiligo: It may affect one dermatomal site (such as glans penis) or asymmetrically affect a single dermatome. This form of vitiligo has an earlier onset and is less frequently associated with other auto-immune phenomenon. This is again classified into the following. Focal- one or more macules in one area but not clearly in a segmental or zoster form distribution. Segmental- one or more macules in a quasi-dermatomal pattern. Mucosal- mucous membrane alone. (e) Lip-Tip Vitiligo (f) Mucosal Vitiligo (g) Universal Vitiligo

Generalized Vitiligo: The generalized pattern is most common. Involvement is symmetrical. This again is classified into the following. Acrofacial- distal extremities and face. Vulgaris- Scattered macules. Mixed- Acrofacial and vulgaris or segmental and acrofacial.

Universal Vitiligo: Universal Vitiligo applies to the cases where the entire body surface is depigmented. Segmental Vitiligo: Segmental Vitiligo usually has an onset early in life and spreads rapidly with in the affected are. The course of segmental Vitiligo can arrest and dipigmented patches can persist unchanged for the life of patient.

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Bheda

Non-segmental Vitiligo: The non segmental type includes all types of vitiligo except segmental vitiligo. The cardinal feature of Shwitra, twacha shwetata is considered as milk white patch told in modern science. Samanya lakshana of Shwitra is not mentioned in Brihatrayee. They have given importance to doshik varieties of shwitra. The classification made by our acharaya is depending upon the color of the patch based on doshik involvement. In modern science it is classified based on the site, extent, distribution of the involved area. Vranaja Shwitra is mentioned as a separate variety in classics. But explanation regarding this is not available in the classics. They stressed on the fact that injury like cuts scrapes, burns can destroy pigment cells resulting in vitiligo. Lesions tend to develop in trauma prone areas, a Koebners reaction is observed. Depending upon chronicity, Vitiligo has seen divided into three stages. a) Active progressive stage. b) Quiescent stage. c) Repigmenting stage. Table No 08: Clinical criteria for classification of Vitiligo: Stages of Vitiligo. Active stage. 1 2 3 Quiescent stage. 1 2 3 Improving stage. 1 2 3 Clinical feature. New lesions developing. Lesions increasing in size. Border ill- defined. No new lesions developing. Lesion stationary in size. Border hyper pigmented and well defined. Lesions decreasing in size. No new lesions developing. Border defined and signs of repigmentation (follicular and peripheral). Zoster form Vitiligo. 1 Unilateral distribution of lesions, preferably along the course of nerves.

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Bheda

Clinical associations Vitiligo 1. Cutaneous. a. Premature graying of hair. b. Halo naevi. c. Alopecia areata. 2. Systemic. a. Thyroid disorders. b. Diabetes mellitus. c. Addisons disease. d. Pernicious anemia. e. Multi endocrinopathy syndrome. f. Oculo and auditory abnormalities.

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Nidana

NIDANA
Karya Karana Siddhanta is amplified in classics for each and every subject. One can predict the Karana (cause) by observing the Karya (production) and vice versa also. This is even true in regards to Shwitra. Nidana plays an important role in the manifestation of a disease. In classics nidana is defined as the factor which leads to the diseases by deranging the equilibrium of the dosha in the body. By observing the Nidana one can predict the forthcoming Shwitra and by observing Shwitra can assess the Nidana61. The knowledge of nidana is essential for the understanding of samprapti and to determine the sadhy-asadhyata and to plan chikitsa. In Ayurveda, nidana have been given inevitable importance because the first line of treatment is nidana parivarjana itself. Coming to the subject proper, i.e. dealing with the etiological factors of Shwitra roga, let us proceed to its study thorough according to the different classical texts. Etiological factors for Shwitra are described only by Acharya Charaka. It has been regarded as a type of Kushta in Sushrut Samhita. Further Vagbhata also states that the etiological factors, which are held responsible for the causation of Kushta, holds same for Shwitra also. Hence it is better to know the etiological factors of Kushta initially under samanya nidana before going to the specific etiological factors of Shwitra. A) Samanya Nidana: The samanya nidana can be broadly classified as follows, 1) Aharaja nidana 2) Viharaja nidana 3) Chikitsa sambandhi nidana 4) Anya nidana 1) Aharaja nidana: In Ayurvedic classics importance is given to ahara. Because samyak yojita ahara leads to indriya parsadana and varna prasadana. But asamyak yojita ahara may leads to several diseases62. Hence Twagendriya ashrita vikara is also included under Aharaja nidana.
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Nidana

Viruddhahara is considered as major nidana for Kushta. Charaka opines that the consumption of viruddhahara insidiously causes vyadhi like Kustha and Shwitra63. Drava ahara by its drava and sara guna vitiates pitta and kapha dosha. This causes agnimandya further leading to rasa dhatu dushti. Tila, moolaka and guda by their ushna veerya cause rakta dushti and shithilata of Shareera64. Similarly snigdha and guru ahara like navanna, masha, pishtanna vitiate the corresponding dosha, dhatu and srotas. Excessive intake of amla rasa causes liquefaction of kapha, increases pitta and vitiation of rakta. Excessive intake of lavana rasa causes vitiation of pitta and abnormal increase of rakta. Excessive intake of Dadhi causes increases of kapha and Srotorodha by its abhishyandi and guru guna. Ajeernashana deranges the jatharagni and leads to the amotpati65. Excessive intake of Madhya, Kshara can also result into vitiation of Pitta, which leads to foramation of Shwitra Kushta. Some unknown factors like intake of Gara Visha has also role in manifestation of this disease. Asatmya bhojana results in vitiation of tridosha. Acharya Kashyapa mentions that asatmya bhojana leads to destruction of bala and varna. 2) Viharaja Nidana: Chhardi nigraha or suppression of chhardi deranges the vata dosha. By this the stasis of kapha and pitta dosha takes place in the jathara and causes Kushta.Vegavarodha causes pratiloma gati or opposite movement of vayu. Gharma66 (Aatapa), shrama, bhayartanam dritam sheetodaka sevanam, ati bhukte vyayama, ati gramaya dharma sevana causes vitiation of tridosha leading to vitiation of dushya. Divaswapna67 increases snigdha guna and kapha dosha in the body, causes derangement of jatharagni and obstruction to the srotas. Ratri jagarana increases vata dosha and rookshata leading to kushta. 3) Chikitsa sambhandhi Nidana: After snehapana patient should not perform vyayama68 or vyavaya as liquefaction of dosha and vitiation of vata occur. Vitiated vata prevents koshtabhimukha movement of dosha leading to kushta roga. After shodhana
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Nidana

procedure patient should avoid Ashta maha doshakara bhava which include vyayama and vyavaya which otherwise leads to depletion of dhatus69. Again it is possible that dosha remain in the koshta may go to shakha and cause Kushta. Improper administration of panchakarma procedures causes Kushta which is more often seen in present days. These are adopted to remove vitiated dosha from the body. If they are not administered properly the vitiated dosha may get mobilized and hence circulate through tiryakgata sira and lodge in the twak. This results in the twak vikara. Some rasadravya like Suvarna, Roupya, Makshika, Heeraka, Tamra, Vanga, Parada, Abhraka, Gandhaka and Haratala when used improperly in the impure state are capable of producing Kushta though they are considered Kushtaghna dravya70. Acharya Kashyapa has said that Kushta roga may also develop if samsarjana karma is not followed properly. 4) Anya Nidana: Other nidana like paapakarma, vipra, guru gharshana, poorvakrita karma, Gohatya, use of money and materials acquired by theft and sadhu ninda or vadha or apamana are also said to cause the disease Kushta71.

B) Vishishta Nidana: Specific causative factors for Shwitra are mentioned only in Charaka Samhita. Acharya Charaka vindicates more on paapakarma, kritaghnabhava, guru gharshana, poorvakrita karma and viruddha ahara72. Viruddha ahara or incompatible diet is mentioned as the prime cause of kushta in general and Shwitra roga in particular. Acharya Charaka has piled up 18 types of incompatible diets. On consuming such foods a person is categorically susceptible for nindita vyadhi. Chakrapani commenting on nindita vyadhi considers Kushta and Shwitra both as nindita vyadhi73. This vitiates pitta pradhana tridosha, which in turn cause rakta dushti and causes Kushta and Shwitra. Also charaka mentions, Shwitra as one of the viruddhahara janya vyadhi74. Acharya Sushruta opines that the viruddha bhojana causes indriya dourbalya, which can be considered as incompatibility of indriya and its adhishtana75.

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Nidana

One of the veerya viruddha bhojana explained as nidana for Kushta is Matsya with milk. Bhadrakapya opines that especially chilachima variety of fish with milk vitiates the tridosha and may lead to shonitaja diseases76. Para samskara, which is interpreted as para samsparshadi means coming into contact with an affected person of Shwitra through touch and other intimacies is also a cause for Shwitra77. If Douhrida apachara is done during the state of pregnancy, i.e. intake of excessive kaphakara ahara, then the Shwitra is said to appear in the baby as a complication78. When Jaloukavacharana is done by vishayukta jalouka, Shwitra occurs at the site of the bite. This is a elite contribution by Astanga Sangraha79. Acharya Bhaluki opines Shwitra as Sahaja vyadhi. After studying nidana aspect it can be said that viruddhahara which is told as a prime causative factor go in favor of nutritional cause which is explained in modern science. Viruddhahara by producing toxins interferes with the absorption of nutrients. In classics para samskara is also mentioned as one of the nidana of Shwitra. But this is just a myth. Garbhaja nidana i.e. consumption of excessive kaphakara ahara by garbhini stree causing Shwitra to the baby cannot be substantiated. Here a question arises how excessive kaphakara ahara sevana by mother afflict the melanin producing system of the body. Rather recent studies have shown that pregnancy can induce Vitiligo in the mother. Also there is no logic, which can be put forth regarding involvement of papa karma, guru ninda, and unlawful acts. These may induce stress in the patient and become Vyanjaka hetu in triggering of further depigmentation. Agantuja factors like Vrana including agnidagdha vrana, injury like cuts scrapes, burns can destroy pigment cells resulting in Vitiligo. Lesions tend to develop in trauma prone areas, a Koebners reaction is observed.

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Nidana

Table No 09 : Etiological factors of Shwitra as per different classics N.


Nidana C.S S.S A.S A.H B.P Y.R M.N B.S H.S G.N

Aharaja nidana 1 2 3 4 5 6 7 8 9 10 11 12 Amlathi sevana Ati drava ahara Ati snigdha ahara Ati guru ahara Ajeerna Adhyashana Ahitashana Asathmya ahara Ati dadhi sevana Chilichima + milk Haviprashana Pippali + kakamachi + lakucha with dadhi + sarpi Garmyanupoudaka + haritha shaka Madhu + mamsa after ushnaahara sevana Ushna ahara after madhu and madhaya sevana Gramya oudaka anupa mamsa with milk Ati masha mulaka pistanna tila Kshara and guda sevana Ati Madhya amla sevana after intake of ksheera + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + -

13 14

+ +

15

16

17

18

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Nidana

N. Nidana C.S S.S A.S A.H B.P Y.R M.N B.S H.S G.N

19

Ati madhu phanita matsya lakucha mulaka kakamachi sevana during ajeerna Intake of yavaka and chanaka with ksheera Ati dadhi takra kola kulatha masha athasi and kusumba snehasevana Intake of mathsya+mamsa+ksheera + nimbuka Lavanathi sevana Mithyahara Mathsyathi sevana Ati navanna sevana Papodaka sevana Viruddhahara Vidagdhahara Vidahi ahara

20 21

+ +

22

23 24 25 26 27 28 29 30

+ + + + + +

+ + -

+ + -

+ + -

+ + + + -

+ + + + -

+ + + + -

+ + +

+ -

+ + + + -

Viharaja nidana 1 2 3 4 5 6 7 8 Ativyayama atisantapa after atibhukta Ati maithuna Ati vyayama Bhaya Chardhi nigraha Divaswapna Gramyadharma after intake of vidagdha ahara Chardhi nigraha after intake of mithya samsarga ahara + + + + + + + + + + + + + + + + + + + + + -

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Nidana

N.
9

Nidana Intake of sheeta and ushna padartha without difference Mithya vihara Parishrama Rathri jagarana Sheetambu sevana after atapa sevana Sheetambu snana or sevana after long walk Tevra dhoopa sevana Vegavarodha Vyayama during ajeerna Anyasthi apaharana Bhramhana, sthree, sajjna vadha Gohathya Poorvakrutha karma Sadhu ninda and vadha Vipra and guru garshana

C.S +

S.S A.S A.H B.P Y.R M.N B.S H.S G.N -

10 11 12 13

+ +

+ +

+ -

+ -

+ -

14

15 16 17

+ + +

+ -

+ +

+ +

+ +

+ +

1 2

+ +

Anya nidana + + + + -

3 4 5 6

+ + -

+ + -

+ -

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Nidana

N.

Nidana

C.S

S.S A.S A.H B.P Y.R M.N B.S H.S G.N

Chikitsa sambandhi nidana


1 Vidahi vidagdha aharaasevana without shodhana Vyayama and gramya dharma after snehapana and Vamana Intake of santharpana and apatharpana without differentiating Panchakarma apachara Ati snehapana + + -

4 5

+ +

+ -

+ -

+ -

Vishistha nidana 1 2 3 4 5 Paapa karma Krithagna bhava Poorva kritha karma Guru gharshana Viruddhahara + + + + + -

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Nidana

ETIOLOGY80:It is accepted that Vitiligo is a multifactorial melody. The various operative factors in the genesis of vitiligo are as below:These various factors are enumerated and discussed in order of their sequence of the pathogenesis. 1. Nutritional deficiency. Theoretically a diet poor in proteins particularly tyrosine can contribute to the causation of Vitiligo. Deficiency of B complex factors particularly thiamin, Riboflavin, pyridoxine, Pathothenic acid and Folic acid is supposed to be casually related to Vitiligo. 2. Amoebiasis- intestinal parasites. These are said to be responsible for Vitiligo by interfering with the absorption of nutrients and by producing toxins. 3. Liver functions deficiency: By impairing detoxification of toxins is supposed to be responsible for vitiligo. 4. Achlorhydria: There are stray reports indicating achlorhydria to be a cause of Vitligo. 5. Endocrinological factors: Amongst endocrinological factors anterior pituitary is possibly the most important. Intermediate lobe of pituitary secrets melanocyte stimulating hormone (MSH). This MSH stimulates melanin formation and dispersal. Except MSH other hormonal factors have a much less significance in the causation of Vitiligo. Association between hyper thyroidism and Vitiligo is noticed many times. ACTH and MSH have some structural similarity and slight functional over lapping. Estrogen increases melanin synthesis and quality of free melanin. Progesterone is supposed to potentiate pigmentory action of oestrogen. Androgens do not have a significant action on pigmentation. 6. Vitamin -C: a. It increases tyrosine decomposition capacity of liver.
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Nidana

b. It increases level of sulphydryl compounds in the tissues. c. As a bio catalyst, by its reducing action it inhibits melanogenesis. d. Vitamin C has a direct fading action on the formed melanin as a result of these modes of action vitamin C appreciably depresses synthesis. 7. Copper deficiency: serum copper studies in Vitiligo by different workers show conflict results. Thus copper deficiency may cause the vitiligo. 8. Heredity: By definition only vitiligo is an acquired disorder. A distance clearcut inheritance is normally never seen in Vitiligo. However, in many cases of vitiligo, family history of the disorder is appreciably noticeable. No specific gene for Vitiligo has been located. The disorder might be due to an inform error of metabolism. There is no proof of its being hereditary. Nearly 40% of cases give positive family history. Inheritance is probably determined by an autosomal gene of variable penetrence. 9. Auto-immune mechanism: Antibodies against melanin have been isolated, from the serum of Vitiligo patients. On this background Vitiligo has been claimed to be an autoimmune disorder. 10. Neural concept: According to this theory, in Vitiligo peripheral nerve endings secrete cytotoxic substances. (Ex- melatonin). These cytotoxic substances have a damaging or destroying action on melanocytes. This neural concept is particularly useful in explaining segmental and unilateral occurrence of Vitiligo. 11. Melanocyte exhaustion theory: According to some workers graying of the hair and Vitiligo and similar processes. Due to the continuous stray of producing melanin, the melanocytes get tired and exhausted. Exhausted melanocytes fail to produce the required quantity of melanin and Vitiligo results. 12. Drugs- chemicals: Like quinones, guanofuracin, amyl phenol, chlorthiazide, broad-spectrum antibiotics, and chloroquin may initiate Vitiligo. 13. Miscellaneous factors: constant rubber friction, pressure and trauma light wearing of saree and dhotis can precipitate the Vitiligo lesions.

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Nidana

Table No 10: Causes of localized hypopigmentation:

Disorders. Vitiligo.

Distinguishing features. Destruction of melanocytes, common, acquired multiple sharply defined non-pigmented patches anywhere.

Pityrias isverscicolor.

Superficial fungus infection, leading to disturbance in pigment production, common, multiple pale scaling patches on trunk.

Pityriasisalba.

Mild patchy eczema of the face in children causing a disturbance in pigment reductions.

Leprosy.

One or several paler macules on trunk or limbs that are hypoaesthetic.

Albinism.

Congenital stationary disorder, distribution may complete or partial. Hairs and eyes may be affected.

White macules of tuberous sclerosis.

Uncommon development of anomaly affecting CNS connective tissue and skin, several maple leaf shaped hypo pigmented macules.

Post inflammatory.

After inflammatory skin disease (often eczema) or trauma to the skin, irregular in shape and in depth of pallor.

Naevus anaemicus. Chemical toxicity.

Rare development solitary white patch usually on trunk thought to have a vascular basis. May look very like vitiligo, seen in workers in the rubber industry exposed to paratertiary benzyltoluene.

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Roopa of Switra

POORVA ROOPA-ROOPA OF SWITRA Poorvaroopa are the premonitory symptoms that occur before the actual disease manifestation. The knowledge of premonitory symptoms is essential in assessing the prognosis of the disease in differential diagnosis and in the treatment. Also they provide a clue to the ensuing disease. There is no reference available about purvarupa of switra in the classics. Shwitra Roga Lakshana are listed as under 1. Padmapatra Prateekasam 2. Aruna mandala 3. Sankha Varna 4. Rakta Varna 5. Swetavarna 6. Aparisraavi 7. Tamra Varna 8. Paarushyam 9. Rookshata 10. Paridaha 11. Paridhwamsi 12. Sadaha 13. Snigdham 14. Bahalam 15. Kandu 16. Ghanam

Roopa or Lakshana of any disease can be broadly grouped under a. Samanya Lakshana b. Vishishta Lakshana Samanya Lakshana and Vishishta Lakshana of Shwitra roga are discussed here.

SAMANYA LAKSHANA OF SHWITRA: Shwitra word itself means 'Twachaswetata' i.e. whitish discoloration of the skin, is a cardinal feature. Acharya has vindicated Aparisraavi i.e. Non-exudative or Non-oozing type of lesion as another important feature of Shwitra roga which differentiates shwitra from Kustha
81

. All together Twacha swetata and Aparisraavi

both are considered as samanya roopa of Shwitra. Shwitra is a disease which has involvement of doshas dhatugatatwa only upto medodhatu, as it is primely Hypopigmentary disorder. Understandings of dhatugatatwa helps in hypothesize the prognosis. In view of this, from the treatment perspective it becomes difficult when there is involvement of deeper and deeper tissues, which is termed as Guru. In other words, deeper the involvement of tissue, the crisis is also deeper.

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Roopa of Switra

Specific colours of skin are mentioned to know course and stages of disease depending upon doshas dhatugatatva as below. When dosha are settled in Raktha dhatu produce Raktha Varna Patches. When dosha are settled in Mamsa dhathu produce Thamra Varna paches. When dosha are settled in Medo dhathu produce Shweta Varna patches82. Yogarathnakara mentioned Pandura Varna, Sasrava and Kandu as Samanya Lakshana of Shvitra; most probably it refers to Vranaja Shvitra83. Acharya Bhela mentioned the presence of Shali shuka prathikasha loma, shukla lohitha Anyonya mandala as samanya lakshana84. VISHISHTA LAKSHANA OF SHWITRA85,86,87,88,89,90: Though Acharya Charaka explained Daruna, Charuna and Shvitra as three names of kilasa and are caused by Tridosha. He has emphasized more on dhatugatatwa of Shwitra91.
Astanga hridaya, Bhavaprakasha, Madhavanidana, Gadanigraha, followed the opinion mentioned in Astanga sangraha; they classified and described the disease into

three types on doshic predominance. They are (1) Vataja Shwitra (2) Pittaja Shwitra (3) Kaphaja Shwitra

(1) VATAJA SHWITRA : The terms Tanu, Paridhwamsi, Aruna Mandala, Krishna, Ajita, Tamra Varna, Parushya, Rookshata, are used to describe the Vataja Shwitra92,93,94. Tanuta is thinness of the skin patches in comparison to the normal skin. Paridhwamsi, i.e. on scratching the patchy area92, a powder like material is found. Aruna varna is appreciated in the patches, apart from this cardinal symptoms like Rookshata, Parushya, Twachaswetata, Aparisraavi which are observed in the Hypopigmented areas. Khara and Rooksha are the guna of vata dosha. It indicates the vitiation of vata dosha. Presence of majority of these symptoms and signs will confirm the condition as Vataja Shwitra.

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Roopa of Switra

(2) PITTAJA SHWITRA : Sadaha, paridaha, Romavidwamsi, Kamalapatra prateekasa, Tamravarna, Padmapatra prateekasa, are the terminologies used to explain the pittaja shwitra92. Localised burning sensation in the patches is understood by daha, where as paridaha is generalized burning sensation all over the body. Romavidwamsi is commented in Atankadarpana as Romaghati, i.e. Destruction of hair in various aspects like size, contour, colour and number etc. Acharya Bhoja mentioned Raktavarna occurs in pittaja shwitra. As mentioned above, these colours can be well verified along with the other group of symptoms. Each colours are having a great range. Considering this fact, these colours can be studied. Padmapatra or Kamalapatra denotes the resemblance of colour of the petals of a Red Lotus. Tamravarna is Coppery red.

(3) KAPHAJA SHWITRA: Kandu, Bahalam, Snigdham, Ghanam, Swetavarna, Pandura varna are the terms used in describing Kaphaja Shwitra92. Kandu (Itching), Snigdham (unctuousness) are observed in areas of Hypopigmentation. Bahalam is thickness of the patchy areas and Ghanam indicates the crowded nature of all the Hypopigmented patches. Panduravarna is slightly yellow mixed white, and white (Shweta) are the colours appreciated in Kaphaja Shwitra. Considering these entire lakshana one can label the condition as Kaphaja Shwitra. Vranaja Shwitra lakshana are not separately dealt by Bhoja92.
Table No 11: Samanya lakshana of Shwitra as per different classics: SL. NO. 1 2 3 4 5 6 7 8 LAKSHANA Shwetavarna Tamravarna Rakravarna Aparisraavi Kandu Arunamandala Parushyam Paridhwamsi C.S. + + + _ _ _ _ _ S.S. + _ _ + + + + + A .H. + + + + + + _ _
45

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Roopa of Switra

9 10 11 12 13 14 15 16

Padmapatra / Kamalapatra Prateekasam Paridaha Snigdha Bahalam Rookshata Daham Romavidwamsi Ghanam

_ _ _ _ _ _ _ _

+ + + + _ _ _ _

+ _ _ _ + + + +

Table No 12: Vishishta lakshana of Shwitra as per different classics: SL. NO. LAKSHANA Vataja Lakshana 1. 2. 3. 4. 5. 6. Arunavarna mandala Parusha Paridhwamsi Rooksha Krishna Tanu Pittaja Lakshana 1. 2. 3. 4. 5. Padmapatra prateeksha Paridaha Tamra varna Roma vidhwamsi Rakta varna Kaphaja Lakshana 1. 2. 3. 4. 5. 6. Shweta varna Snigdha Bahala Kandu Ghana Guru + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + S.S. M.N. A.S. B.P. R.R.S Bhoja

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Roopa of Switra

CLINICAL FEATURES: APPEARANCE95 Completely depigmented macules and patches of varying sizes and shapes characterize it. Besides loss of colours, there is no other structural change. The depigmented areas are pale white or slightly pink and ill defined at the start of the disorder. In doubtful cases, the pigmentation can be made to appear more distinct by pressing the patch with a glass side. This pressure momentarily obliterates the blood supply and hence the dipigmentation stands out more prominently. In early doubtful cases examination under woods lamp is also helpful. Often the depigmented patches are symmetrical, especially when the disorder is distributed over the peripheral parts of the limbs and the face. The border: A rim of hyper pigmentation generally lines the border of the depigmented patch. It looks as the pigment is removed from the patch and is thrown at the periphery. Hair on the patch: Hair may or may not become depigmented in vitilliginous areas. Presence of depigmented hairs (leucotrichia) or a patch is a strong point in favor of the diagnosis of Vitiligo. Distribution- lesions: distribution of the lesions is determined by the supply and demand behaviors of the pigment commodity. Whenever there is scarcity of any commodity two diagonally opposite areas suffer most thus; 1. Peripherally situated, badly supplies areas, which are even normal at a critical level of supply with little or no stored material, suffer commonly. Hence mucocutaneous junctions, finger tips, palms, soles, and toe lips are commonly involved in any extensive Vitiligo. 2. Areas where the consumption rate is normally very high suffer most in any scarcity or pigment commodity. Pigmented like nipples, scrotal skin, scalp (because of hair) and moles are also commonly involved in any extensive Vitiligo. 3. Clinical forms: a) Focal b) Segmental Common lesions: a) Scalp. b) Retro-auricular folds. f) Nipple. g) Waist.
47

c) Acrofacial-lip-tip d ) Generalized

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Roopa of Switra

c) Upper eye lids. d) Lips. e) Finger tips, palms.

h) Scrotum, glands. i) Legs. j) Toe tips and soles.

Often the depigmented patches are symmetrical, especially when the disorder is distributed over the peripheral parts of the limbs and the face. Zoster form Vitiligo: lesions develop along the distribution of a peripheral nerve. Halo nevus (Suttons nevus) - a related disorder in which the depigmentation begins around one or a few compound naevi. Occupational Vitiligo (Oliver):- it is seen on the dorsum of the hands of tannery workers caused by the use of rubber gloves containing agrerite Alba. Monobenzyl ether of hydroquinone (MBEH). The chemical gets dissolved by sweat and acts on the melanocytes in such away as to interfere with the formation of melanin. In early cases, depigmentation may disappear spontaneously. The onset of this disorder is slow and the course insidious but enigmatic. It may continue to increase slowly or come to a halt and then increase again. There may be spontaneous recovery in very small percentage of cases. This malady starts and much noticeable in the summer.

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Samprapti

SAMPRAPTI (PATHOGENESIS)
The treatise of Ayurveda signifies that both Kusta and Shwitra are having common causative factors and also treatment. It is thus extrapolated that Samprapti of Kusta holds good for Shwitra also, may be a little deviation can be inferred in the pathogenesis of shwitra. Ultimately the goal of treatment which is exactly aimed at disintegration of pathological agencies in Shwitra by specific drugs, has been mentioned for Shwitra chikitsa. There are some lakshana differ from Kusta which signify a variation in the Samprapti of Shwitra in Comparison to Kusta. The cardinal symptom of Shwitra is the discoloration96 of the twak. This milestone has more value while scrutinizing the Samprapti of Shwitra. Inferentially the mechanism responsible for creation and maintenance of the Varna, Chaya and Prabha gets hampered. Thus a Roadmap of discolored skin comes as the Samprapti proper; Ukta Nidana causes tridosha prakopa and simultaneously causes shaithilyata in Twak Rakta, Mamsa and Medas. These prakupita dosha are propelled through rasayanee throughout the body. When dosha are propelled in the body which are having sthira guna will gets lodged in shithila, Twagadi sthana and results into Srotosanga of Raktavaha, Mamsavaha, and Medovaha srotas. This insidiously leads vitiation of local pitta i.e. Bhrajaka pitta and causes Shwitra. Though all the three98 dosha are involved, mainly udana vayu and Bhrajaka Pitta are specially vitiated. These two are held responsible in maintenance of Twak Varna. The enhancement of Samprapti depends on the localization of dosha in the respective dhatu. In the initial stage the doshas settled in Rakta presents Aruna varna. By promotion of dosha into Mamsa, they produce Tamra Varna and lastly dosha migrates to the Medas and settles to produce Shweta varna in the relevant portion of skin.

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Samprapti

SAMPRAPTI GHATAKA Dosha : Pitta Bhrajakapitta Vata- Udana vata Kapha Dushya Agni Srotas : ; : Twaka, Rakta, Mamsa and Medas Jathargni Janya Mainly Raktavaha srotas Daruna Kushta involves Mamsavaha srotas Charuna Kushta involves Medovaha srotas Srotodusti prakara Udbhava Sthana Sanchara Sthana Roga-Marga Adhisthana Vyaktasthana : : : : : : Sanga Amasaya and Pakvashaya Sarvasharira Bahya Twak Twak

1) SANKHYA SAMPRAPTI: Charaka, Sushruta and both Vagbhata classified three types of Shwitra. Bhojacharya and Bhaluki described only two types. 2) VIKALPA SAMPRAPTI: Sushruta and Vagbhata classified three types of Shwitra as Vataja, Pittaja and Kaphaja, Bhoja and Bhaluki classified two varieties of Shwitra as Vranaja and Doshaja. While considering ashraya of dosha; Charaka described Shwitra as Raktasrita. Mamsasrita and Medoasrita. 3) BALA SAMPRAPTI: When dosha are settled in Rakta dhatu possess alpa bala, when the same dosha settle in Mamsadhatu possess Madhya bala, the dosha When they are settled in Medodhatu posess pravara bala.

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Samprapti

4) KALA SAMPRAPTI: Shwitra, after its appearance, within one year, is designated as Navam and its prognosis considered as good i.e. Sadhya (curable). Shwitra after one year of its appearance is considered as Asadhya (incurable).

(5) PRADHANYA SAMPRAPTI: Shwitra is a Swatantra vyadhi. Sometimes it may occur as Paratantraja even. For e.g. as a complication- mismanagement of Agnidagdha Vrana (Burns/Scald)

(6) VIDHI SAMPRAPTI: According to Charaka, three types of Shwitra are there. All are Tridoshaja. They are as followsDaruna Shwitra Charuna Shwitra Kilasa Shwitra

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Samprapti

PATHOLOGY:

HISTOPATHOLOGY: The essential feature is absence of melanin pigment. There are no other histological changes. The area surrounding the white patches shows increased pigmentation and the blood vessels, hair follicles and glands are surrounded by pigment cells. The skin on the whole looks normal; melanocytes are not much reduced in number with normal shape (appearance). But when the skin is incubated with DOPA reagent, the melanocytes take smooth homogenic coloration, which indicates that there are inactive melanocytes. Activity of melanocytes is indicated by their granular appearance. Vitiligo is a functional and not a structural anomaly.

a. A defect in enzyme a copper cantening tyrosinase is held responsible for vitiligo. According to some, melatonin a substance secreted at nerve endings inhibits tyrosinase, thus interfering in pigment formation. b. The Vitiligo appears to be due to an immunological attack on the melanocytes. This would suggest that vitiligo is an autoimmune disorder.

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Samprapti

DIAGNOSIS:

1) History. 2) Clinical features Woods lamp- is of great help in diagnosis of Vitiligo. DIAGNOSTIC CRITERIA99 1) Medical history: Evaluation and diagnosis of Vitiligo require obtaining the following information: 1. The age of onset of the white spots; Vitiligo rarely begins before the age of 6 months. 2. Family history of Vitiligo and early graying of the hair (i.e., significant loss of hair color before the age of 30 years. 3. Inflammation, irritation, or rash preceding the white spots. 4. Potential precipitating events including emotional stress, physical illness, sunburn, or other forms occurring within 2-3 months prior to the onset of de pigmentation. 5. Personal stress to the patient resulting from the disease. 6. Ocular or auditory dysfunction. 7. Previous forms of therapy, either systematic or topical, how the therapy was prescribed, and the effects or toxicity of the treatment. 8. Stability or progression of the disease. 9. Allergies and personal family history of atopy. 10. Occupational hazards and hobbies to define chemical exposures that might be responsible for chemically induced Vitiligo. 11. Personal or family history of associated diseases including thyroid disorders, premature graying, alopecia aerate, diabetes mellitus, collagen vascular diseases, pernicious anemia, and Addisons disease; personal history of other disorders aggravated by photo exposure or of photosensitivity. 2) Physical examination. The diagnosis of Vitiligo is based exclusively on the clinical examination of the patient. The physical examination includes the following findings; the presence of acquired asymptomatic depigmented macules or patches, usually without clinical
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53

Samprapti

signs of inflammation. Hypo pigmented lesions may coexist with depigmented lesions. Such trichrome lesions are often observed in individuals with darker skin. Trichrome Vitiligo is characterized by depigmented, hypopigmented, and normally pigmented skin. About 2% to 5% of patients may exhibit one or more depigmented lesions with dermatitic / inflamed borders. Vitiligo lesions may be found in any area of the body. The initial lesions are frequently found on the hands, forearms, feet, face and lips. The borders of the lesions are usually discrete and well defined. The distribution of skin lesions, the number, and the appropriate surface area of the integument involved by depigmentation should be determined in order to establish the baseline extent of the disease. Some investigators classify Vitiligo into two groups- generalized and segmental. Others subclass generalized Vitiligo into three subcategories. 1. Generalized symmetric macules or patches occurring in a random distribution over much of the body; acral/acrofacial depigmented macules or patches confined to the extremities and /or face; focal/localized- isolated macules or patches on one or two sites of the body. 2. Segmental Vitiligo restricted to one portion of the body such as one leg, one portion of the trunk, or the face. The lesions are rare if ever distributed in a dermotomal pattern. Other important physical findings include acquired depigmented hairs within a vitiliginous region and poliosis of scalp hair, eyelashes, eyebrows, and/or beard hair. Areas of hypo pigmentation and hyper pigmentation of the choroid and retinal pigment epithelium may be evident by ophthalmologic examination, the presence or absence of uveitis also should be determined. This examination is best done by an ophthalmologist is of particular importance if the patient has complaints of photophobia, decreasing visual acuity, or poor night vision. For patient with fair skin, such as those with skin types I or II, detection of depigmented or hypo pigmented patches of Vitiligo may require the use of woods lamp to delineate the areas of involvement. In-patients with darker skin, a woods lamp examination also can be helpful to assess the degree of hypopigmentation or depigmentation in individual lesions.
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Samprapti

DIAGNOSTIC TESTS In most instances the diagnosis of vitiligo is based on the history and physical examination. However, in some instances additional diagnostic tests may be indicated to differentiate Vitiligo from conditions that may mimic it clinically. These conditions include piebaldism, nevus depigmentosus, nevus anemicus, post inflammatory depigmentation hypo pigmentation, pityriasis alba, tinea versicolor, discoid lupus erythematosus, and scleroderma. In addition, certain tests are sometimes helpful to detect the presence of associated systemic disorders such as thyroid disease, pernicious anemia, diabetes, or Addisons disease. Some useful tests include the following. 1. Biopsy from the border stained with Fontana Masson technique to differentiate Vitiligo from some of the aforementioned conditions. Melanocytes are decreased in the early stages of Vitiligo. As the disease progresses, they are completely absent. Other changes include basilar vaculopathy, exocytosis of lymphohistiocytic infiltrates, especially in inflammatory Vitiligo. For most patients a biopsy is not necessary. 2. Baseline blood chemistry may include a complete blood count, a differential with erythrocyte sedimentation rate, and thyroid function studies including thyroid stimulating hormone. In addition, tests for antiparietal cell, antithyroid (thyroglobulin and microsomal), and antinuclear antibodies are frequently indicated. These tests are more important if signs or symptoms of endocrine disease or collagen vascular disease are present. Abnormal test valves should be followed clinical or by laboratory examination as indicated. 3. If patients are to undergo photo chemotherapy, a baseline ophthalmologic examination and antinuclear antibody determination are advisable. Some physicians recommend a repeat of these tests at 6-month intervals. Other at 12 month intervals while on PUVA therapy. In appropriate diagnostic tests include serum alpha-MAS levels, serum ACTH levels, hair analyses, and trace metal analyses.

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Samprapti

Special Investigations: 1. Woods lamp examination: Diagnosis of Vitiligo is made by inspection with woods lamp. Ultra violet light of 365nm wavelength is obtained by passing the beam through a Woods filter composed of nickel oxide containing glass. The examination has to be done in a dark room. Inspected Vitiligo patch appears milky white. 2. Skin Biopsy: Skin biopsy will show absence of melanocytes and melanin in the affected area.

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Sapeksha Nidana

SAPEKSHA NIDANA
It is essential to rule out other possible diseases, which are having the similar signs. The cardinal feature of Shwitra i,e. twacha shwetata and aparisravi are not present together in any of the disorders mentioned in the classics. Sidma, which is one of the mahakushta, simulates with shwitra. Differentiating features between these two are as shown in the table. Table No 13: Distinguishing features between shwitra and sidma: SL. NO. 1 2 3 4 5 6 DISTINGUISHIN G FEATURES Dosha Dhatu Poorvaroopa Colour Roopa Area of lesions SHWITRA Tridoshaja Rakta,mamsa & medas Absent Shweta,Aruna, Tamra SIDMA Kapha-vataja pradhana Tridoshaja Saptha dhatu Present Sweta,Tamra,Alabu-Pushpavat

Aparisravi or no Rajo ghrushtam vimunchati or change on scratching powder like material or scratching Occurs anywhere Most common in upper part of the body especially Uras

Table No 14: Distinguishing features between kusta and Shwitra: SL. NO 1 2 3 4 5 6 7 8 DISTINGUISHING FEATURES Dhatu Dosha Layer of skin Krimi Secretion Sensation Infection Genetics KUSTA Saptha dhatu Tridoshaja Confines to all layer of the skin Krimijanya Sraava present Sparsha vikruthi present Sankramika roga Non hereditary. SHWITRA Rakta,mamsa & medas Tridoshaja Confines to the skin only especially 4th layer of skin i.e. Tamra Not so Aparisraavi Prakrita sparsha present Not so Non hereditary but runs in the family

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Sapeksha Nidana

DIFFERENTIAL DIAGNOSIS OF VITILIGO Causes for localized depigmentation of skin: in many countries the fear of leprosy makes differential diagnosis of a white patch an urgent and vitally important issue. Examination of the skin in long wave UVR helps distinguish whether these is total depigmentation (as in Vitiligo) or not. It may also detect areas of depigmentation not easily seen in ordinary daylight as well as detecting a lemon-yellow fluorescence seen in some cases of pityriasis versicolor. For the differential diagnosis of vitiligo following diseases are considered -Albinism. -Naevus Depigmentosus. -Leprosy. -Pityriasis verisicolor. Explanation of these disorders is as shown in the Table No Table No 15: Differential diagnosis of vitiligo:
SL. NO DISTINGUIS HING FEATURE Age Distribution Course ALBINISM Congenital Complete/ Partial Stationary NAVUS DEPEGM ENTOSUS Congenital Unilateral Stationary VITILIGO Acquired Any area Progressive. LEPROSY Acquired Any area Progressive PITYRIASIS VERSICOLOR Acquired Truck, Neck and face Progressive, worse in monsoon & summer -

1 2 3

Hyper pigmentary border Heredofamilial Other features

Present

Inflammatory . Anesthesia thickened nerves

5 6

Hereditary Hairs and eyes may be affected

No Hereditary -

Hairs may be affected

Furfuraceous scaling, pin head macules and large patches of fungus on microscopic examination

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Sadhya-Asadhyata

SADHYA-ASADHYATA
Prognosis of the disease is known through observing the sadhyaasadhya lakshana. Thorough giving an eagle eye view over this lakshana, one can know whether the disease is curable or incurable at first. Then if it is curable, further one can know whether it is easily curable (Sukha Sadhya) or difficult to cure (Krichra Sadhya). If it is incurable, can it be managed by medicines (Yapya), or totally incurable (Asadhya) all these things are essential to know before starting the treatment itself. Shwitra patches, having following lakshana, can be considered as curable. Na athi chirotthitam or Navam refers to a patch with a year of its appearance; Tanu or Abahalam means which are ununited; Asuklaroma100 or Araktaloma101 means Hairs which are not white or red; Anagnidagdajam102 refers to patches not as a consequence of burns/scald; Panduvarnayuktha or Varnenaiva dirgubhayam means patches with pallor colour and patches with two colours are curable. Varsha ganotpannam- patches of chronic origin; Suklaloma yuktha - which have leucotrichia; Bahalam - which is thick; Sambadda Mandalam or Paraspara Abhinnam; Guhya Panitala and Osthagata - patches appeared over the groins, palms and lips are incurable. Cure corresponds with the reduction of paapa karma103. Dosha when they are settled in Rakta, Mamsa and Medas it becomes difficult to treat as the deeper tissue involvement is taking place. In other words deeper the involvement of tissue, the crisis is also deeper104. Awareness in the above aspect will give us a clear-cut idea of the disease and its prognosis before commencing the treatment itself.

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Sadhya-Asadhyata

Table No 16: Shwitra sadhya asadhyata of Shwitra as per different classics

SL.NO.

LAKSHANA SADHYA

C.S.

S.S.

A.H.

1 2 3 4 5 6 7

Tanu/Abahalam Pandu Na athi chirothitam/ Navam Maayavakashe/asamislitam Varnenaiva drigubhayam Asuklaromam Anagnidagdhayam ASADHYA

+ + + + -

+ + + + + +

1 2 3 4 5 6 7

Paraspara abinnam/ Sambadda Mandalam Bahuhu/Bahalam Yat Rakta lomavat Varshaganotpannam Antarjatam Rakta loma vata Agni dagdha Guhya, Panitala, Ostagata shwitra

+ + + + -

+ + + + -

+ +

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Pathyapathya

PATHYAPATHYA

105,106,107

The food regimen plays a vital role in human body. Proper administration promotes the health and its adverse leads to disease. In our classics this phenomenon is implied to pathya-apathya. Here pathya-apathya is told for both food and regimen. In classics Acharya have not dealt with specific pathya-apathya of shwitra separately. Hence the pathya-apathya explained under the context of Kustha1 can be considered here also which are as shown in the Table. Table No 17: Pathya in Shwitra Sl. No. 1. Shastika shali 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. (rice that matures in 60days) Yava (barley) Godhuma.(wheat) Koradusha Shyamaka Uddalaka Mudga (green gram) Adhak Masoora Nimbapatra Arushkara Priyangu Mandooka parni Khadira kashaya pana Patola Brihati phala Chakramarda Meshashrungi Koshataki Tila (seasum) Punarnava Go,Khara,Ustra,Ashwa,Mahishi Mootra Sarpi (ghee) Tikta shaka Bhallataka Triphala Jangala mamsa Pathya Vihara + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + Pathya Ahara- Vihara Pathya Ahara C.S. + A.S. + Y.R. S.S. +

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Pathyapathya

1. 2. 3. 4. 5. 6. 7. 8.

Khadira jala parisheka Virechana Aragvadhadi kashaya, Udwartana Khadirodaka Avagaha Vajraka tailabhyanga Vrata Yama Dwija, Sura Pooja

+ + + -

+ + + -

+ -

Table No 18: Apathya in Shwitra Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 1. 2. 3. 4. 5. 6. 7. Apathya Ahara- Vihara Apathya Ahara Guru anna Drava anna Guda (jaggery) Dadhi (curd) Dugdha (milk) Matsya (fish) Masha (black gram) Tila (seasum) Navanna Anoopa mamsa Maricha (black pepper) Amla, Lavana rasa Kulattha (horse gram) Mamsa rasa Nispava Ikshupista Viruddhashana Adyashana Ajeernashana Vidahi, Abhishyandi ahara Apathya Vihara Papa karma Diva nidra Viruddhashana Vishamasana Vyayama Vegavarodha Vyavaya C.S. + + + + + + + + + A.S. + + + + + + Y.R. + + + + + + + + + + S.S. + + + + + + + + + + + + + + + +

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Chikitsa Vivechana

CHIKITSA VIVECHANA
The term chikitsa is derived from the root word kit rogapanayane i.e., measures calculated for the removal of factors of the disease. According to Vaidyaka Shabda Sindhu, it has been defined as -that which eradicates the disease. Acharya Charaka says that the mere removal of the causative factors of the disease may not always result in the total removal of the disease; as such the effect of the disease may still continue to be operative. Hence in his view, chikitsa aims not only at the radical removal of the causative factors of the disease but also at the restoration of the doshik equilibrium108. Prime importance of chikitsa lies in breaking up of the samprapti. The prognosis of Shwitra depends upon the early diagnosis and prompt treatment. Here in we can cite a quotation as told by Acharya Vagbhata, the meaning of which runs as Shwitra is considered as more bibhtasa than that of Kushtha. Further he quotes analogy of a burning house. If a burning house is neglected, within a short period of time the flame spread to adjoining house. Hence immediate measures should be taken to extinguish the flame. Likewise the treatment of the Shwitra should be started immediately. Chakrapani109 commenting on Shwitra chikitsa mentions that the treatment of kustha holds good even for the Shwitra, however it should be adopted intensively. In the treatment of Kustha, shodhana procedures are advised prior to all other types of treatment. Depending on the predominance of dosha, snehapana is indicated in vata pradana kustha, vamana in shleshma pradhana and virechana and raktamokshana in pitta pradhana Kustha. In the kalpasthana of Charaka Samhita, there are description of dravya meant for vamana and virechana. If there is bahu dosha, shodhana therapy is indicated to eliminate them. Repeated vamana and virechana has to be adopted, mean while taking precaution that the bala of the patient is not diminished. In the lesions that are sthira and Kathina mandala, nadi and prastara type of sweda must be given and scraped by kurcha and raktamokshana has to be done. Acharaya Susruta says that treatment can be started soon after the appearance of premonitory symptoms. He further explains the specific line of treatment apart from the general treatment when dosha are located in each dhatu.
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Chikitsa Vivechana Dosha in twak Shodhana karma and alepa. Dosha in raktadhatu Shodhana, alepa, kashaya pana, raktamokshana, aristha and mantha pana. Dosha in medodhatu It becomes yapya by its virtue110. While explaining general line of treatment of kustha, Acharya Susruta and Vagbhata both have mentioned identical procedures. Vamana for every 15 days, virechana for once in every 30 days, shirovirechana for every 3 days and rakthamokshana for every six months are to be administered111,112. Inspite of all these treatment procedures, the patient must consume Khadira vari or decoction of Khadira. He must use the same for Snana. Also the yavagu prepared from Khadirambu must be consumed113. Apart from the general line of treatment of kustha, specific line of treatment for shwitra has been given in Charaka Samhita. Both Acharya Charaka and Vagbhata have stressed on the shodhana therapy followed by sramsana coupled with shamana to alleviate the Shwitra. Sramsana is mentioned as the therapy of choice for Shwitra roga. It is advocated after purificatory measures like vamana and virechana114. For the purpose of Sramsana Malapurasa with guda is given for a minimum period of three days. The patient is anointed with sneha and exposed to the sun depending on the strength of the individual. If sphota or blisters appear on the hypo-pigmented areas, they should be opened and drained with a kantaka. At this stage if the patient feels thirst, peya should be given. Then the patient is given decoction made up of Malapu, Asana, Priyangu and Palasha Kshara or Khadhira kasaya along with phanitha115. Aragwadha is mentioned as best Sramsana dravya. Rakta mokshana is also indicated in the treatment of Kushta Roga especially in Shwitra. The Raktamokshana procedure is considered one among the Pancha shodana. Raktamokshana is a process of letting the vitiated blood out of the body as a treatment procedure in disease caused by Rakta or pitta and carried out either by using sharp surgical instruments or by means of parasurgical measures, in selected persons with quantity only. Savarneekarana is one of the sixty Vranopakrama mentioned by Acharya Susrutha done to bring back the normal colour of the skin in a healing wound. Savarneekarana includes both Krishna karma and Pandu karma. Krishna karma is more relevant in the treatment of Vranaja Shwitra.
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Chikitsa Vivechana Apart from all the therapies, Shwitra can be cured only in the persons who are devoid of paapa karma116. Daivavyapashraya chikitsa is also mentioned in the treatment of Shwitra. Acharaya Hareeta says raupya-dana or giving away silver to alms helps in alleviating Shwitra. The main nidana of Shwitra is viruddhahara. Hence nidana parivarjana also plays an important role in the treatment of Shwitra. Going through the chikitsa sutra described in the classics it can be said that the treatment explained in the classics is shodhana and shamana. The later includes internally Shwitra nashaka yoga along with daivavyapashraya chikitsa and externally in the form of lepa. Shwitra is one among the rakta pradoshaja vikara. Sramsana is a type of adhobhagahara shodhana karma helpful in the diseases occurring in the skin especially in Shwitra. Lepa is also beneficial. Considering these factors Shwitra chikitsa is framed as follows. Ama pachana :- It is very essential before every shodhana procedure. Tikta, katu and agni deepana dravyas are administered to correct jatharagni till nirama lakshana are obtained. Snehapana:- After nirama lakshana are observed patient is subjected to snehapana procedure. Sneha is administered considering bala, agni and koshtha. The selected sneha dravya is administered in the early morning hours, which should be in hrusi yasi matra on the first day. Considering the time taken for the digestion of the hrusiyasi matra of sneha, on the second day calculated amount of sneha is given along with saindhava lavana117. Abhayanga and Sweda:- After administering sneha internally, abhayanga and sweda are administered for three days. Snehana and Swedana help in the further liquefaction of klinna dosha which are situated in the sukshma marga and also help in easy entry of the dosha from shakha to koshtha and from there elimination through the nearest route. Though Swedana is contraindicated in Kustha, have mridu swedana in the form of ushna jala parisheka is advised. Sramsana:- After abhyanga and sweda, by assessing the kostha of the patient

oushadhi is given for the purpose of sramsana in shleshmanta kala- Shleshma kale gate jnatwa kostham samyak virichyate118. Then the patient is advised to take hot water in little quantity frequently. Patient is observed for vega pravrutti. Considering the suddhi prakara, samsarjana is advised. Afterwards, shamanoushadhi or palliative medicines are started.
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Chikitsa Vivechana LEPA CHIKITSA119,120,121: Lepa chikitsa is one of the main components of Bahir Parimarjana Chikitsa. Lepa or external application of medicinal drugs is the choice of treatment in various skin disorders, swellings, painful conditions, wounds and pruritis. It also has a cosmetic value as it has the benefit of repigmentation and avoiding scar formation in the wounds. Lepa is a procedure where in the medicine is made in the form of paste with milk or kanji or gomutra or water and applied to the skin. A detailed description about lepa, its application, and mode of action, types and indication is available in Ayurvedic classics. Synonyms of lepa include lepana, alepa and lipta. Other terms used in the context of lepa are pralepa and pradeha. Karmukata:Alepa is a prime therapy for cleansing the twacha. It also has the action purifying local rakta and mamsa. Lepa is always advised to be applied from the opposite direction of the hair follicles. It promotes entry of lepa dravya through hair follicles. The veerya of lepa dravya reach the siramukha of swedavaha srotas. This explains the mode of action of lepa dravya. Exposure to Sun Light: Atapa sevana is considered as one of the methods of langhana as well as anagni type of swedana. These two procedures are meant for increasing agni. Here atapa sevana increases Bhrajakaagni directly. In the treatment the patient is advised to expose the hypopigmented skin portion to sunrays. The time for exposure to sunlight is in the early morning hours. Early morning sunrays contain UV rays which stimulate the skin pigmentary mechanism. Facultative or inducible skin colour which results from the exposure even in normal individuals commonly known as Tan is stimulated. (Harrisons principle of Internal Medicine).

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Chikitsa Vivechana
Table 19: List of drugs used internally and externally
Sl no

Name of the yoga Patola muladi kwatha Manibhadra yoga Malapu rasa + guda

C.S

S.S

A.H

A.S

B.P

Y.R

B.R

G.N

C.D

Virechana dravya + -

2 3

+ +

Malapu + asana+ priyangu + shatapushpa 2 Badrodumb aradi yoga 3 Dhatriyadi kwatha 4 Khadiradi kashaya 5 Vibhitaki Tvak + malapu mula + bakuchi churna 6 Bakuchi + amalaki + khadira 7 Dhatri khadira kwatha 8 Vibhitakya di kwatha 9 Manjistadi mahakasha ya 10 Gomutradi yoga 1 2 Musthadi churna Pancha nimba churna Khadirasara di churna

Shamanoushadhi - Kwatha + -

+ -

+ + -

+ -

+ + -

+ -

+ +

+ -

Churna + -

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Chikitsa Vivechana

Sl no

1 2 3 4

Name of the yoga Bhallataka avaleha Panchanib avaleha Mahabhalla taka guda Mahabhalla taka avaleha
Madhvasava

C.S -

S.S -

A.H -

Avaleha A.S -

B.P + +

Y.R + -

B.R + -

G.N -

C.D -

1 2 3

Kanaka bindwarista Gomutrasa va Swambu guggulu Swetari rasa Triphala gutika


Shashilekha vati

+ + -

Asava - Arista + Vati -

1 2 3 4 5

+ -

+
+

+ -

Vijayeshwar rasa

1 2

3 4 5

Thiktaka ghrutha Mahathikt aka ghrutha Mahavajra ka ghrutha Avarthaki ghrutha Somaraji ghrutha Mahavajra ka taila Aragvadha dhy taila

+ +

Ghrutha -

+ + -

+ -

1 2

Bahya oushadhi taila + -

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 68 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Chikitsa Vivechana
Sl no

4 5

6 7 8 9

Name of the yoga Swalpa marichadh ya taila Visha taila Kusta rakshasa taila Marichady a taila Kandarpas ara taila Jyothishm athi taila Laghu vishagarbh a taila Mahaneela ghrutha

C.S -

S.S -

A.H -

A.S -

B.P +

Y.R -

B.R -

G.N -

C.D +

+ -

+ +

+ -

+ + -

+ + -

Ghrutha Lepa -

Shiki Pitta Lepa 2 Krishna sarpodbha va masi + aksha taila 3 Savarnakar a Lepa 4 Gajalinda kshara + bakuchi 5 Bhallataka di Lepa 6 Burnt skin of elephant + taila 7 Puti keeta + aragvadha kshara 8 Kukkuta pureesha yoga 9 Avalgujadi varthi 10 Thuttadi Lepa

+ -

+ +

+ +

+ +

+ -

+ +

+ +

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 69 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Chikitsa Vivechana
Sl no

11 12 13 14

15 16

Name of the yoga Shvitranas hana Lepa Marichadi Lepa Bhallataka Lepa Aragvadha shatchurna pradeha Puthikadi Lepa Avalguja beejadi Lepa Shweta jayanthi mula kalka Shiladi Lepa Triphaladi Lepa Ayorajadi Lepa

C.S -

S.S -

A.H + + + -

A.S -

B.P -

Y.R -

B.R -

G.N + +

C.D +

+ -

+ +

17

18 19 20

+ +

+ + + -

21 Kadaliksha ra + kharasthi bhasma + goraktha 22 Malathi koraka Kshara+ hasthi mada 23 Neelotpala + kusta +saindhav a + gaja mutra 24 Mulaka beeja + avalguja + gomutra 25 Kakodumb ara + avalguja + chitraka + gomutra

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Chikitsa Vivechana
Sl no

Name of the yoga Bakuchi beejadi Lepa Bakuchi + haratala + manashila + gunja + chitraka Neelaparaj itha mula Lepa Manashila + apamarga bhasma Gandhaka + chitraka + pippali + haratala + haritaki Gruhadhu madi Lepa
Sudarshana mulayoga

C.S +

S.S -

A.H -

A.S -

B.P -

Y.R -

B.R -

G.N -

C.D -

26

27

28

29

30

31 32

+ + + -

33 Bakuchyad iLepa 26 Bakuchi beejadi Lepa Bakuchi + haratala + manashila + gunja + chitraka Neelaparaj itha mula Lepa Manashila + apamarga bhasma

27

28

29

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Chikitsa Vivechana

Sl no

Name of the yoga Gandhaka + chitraka + pippali + haratala + haritaki Gruhadhum adi Lepa Sudarshana mulayoga Bakuchyadi Lepa

C.S

S.S

A.H

A.S

B.P

Y.R

B.R

G.N

C.D

30

31 32 33

+ + +

Treatment of Vitiligo ( As per modern) Line of treatment followed in modern science is, Educate and encourage relatives, friends and society to overcome the stigma that this is not infectious. Reassurance that this is a cosmetic problem and does not affect the patients health directly. Educate the patient about the nature of the disease. Application of sunscreen avoids sunburn injury. Cover mark and derma blend are cosmetics that can be used to match most skin hues. PUVA Therapy (Psoralen photochemotherapy)122 Topical or Systemic. Topical PUVA involves Ultraviolet A radiation thirty minutes after application of topical Methoxasalen to the localized vitiligenous area. Systemic PUVA involve ingestion of Methoxasalen (0.6mg/kg) two hours before irradiation. Creams containing corticosteroid compounds in small areas of Vitiligo along with other treatment. Systemic steroids are also useful123. Grafts from uninvolved skin containing viable melanocytes124

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Drug Review

DRUG REVIEW
Aushadha is one which removes the fear of disease and also the disease itself. By executing two main goals such as remedial of illness and promotion of health it is made clear about action o f aushadha in the body. Thus it is considered as synonym of chikitsa. Process of attainment of morbidity of Dosha till the manifestation of disease is known as Samprapti and the measures which bring discontinuity in Samprapti and reversing the process is known as chikitsa. The drug or diet articles that reverses or break the Samprapti is ideal for the particular disease. The drug can be used in combination or singly to achieve this. It is mostly the total efficacy of all the ingredients of formulation rather than the action of individual drugs that plays a prime role in treatment. Keeping in view the above facts, In the present study the formulation Shashi lekha vati125 along with Gomutrasava126,127 converted into Gomutra Ghana vati for better palatability are selected for the disease Shwitra in present study. The detail of the same is given below

A) Composition of Shashilekha Vati125 :(Y.R.-Kustha NidanaChi.)


1. Suddha Parad 2. Suddha Gandhak 3. Tamra Bhasma 4. Shodhita Bakuchi(Seeds) : 125 mg tid : 1 Part : 1 Part : 1 Part : Quatha for Bhavana (q.s.)

Indication : Shwitra, Kushta . Matra Anupana : Bakuchi Taila 1 Karsha(10gm) with Madhu Method of Preparation

Shuddha Parada and Shuddha Gandhak should be mixed in equal quantity followed by adding equal quantity of Tamra Bhashma. Bhavana with Shodhita Bakuchi seed Kwatha should be given to it. Fine powder of the mixture should be obtained, dried and later vati is prepaired.

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Drug Review

1) BAKUCHI128
Latine name Family Vernacular name Synonyms Rasa Guna Virya Vipaka Doshaghnata Part used - Psoralia corylifolia Linn. - Pappilionacae - Hindi: Bakuchi - Guarati: Bavachi - Somraji, Kusthaghni, Krisnaphala : Katu, Tikta : Laghu, Ruksha : Ushna : Katu : Kapha-vatashamak : Seeds, seed oil Rasa panchak

Chemical composition:Large numbers of compound were isolated from Bakuchi. Bakuchiol isolated from fruits, synthesis of Bakuchiol,two coumamarins bava coumarins A and B isolated from seeds and sophoracomastan also isolated. A new furanocoumarin, bakuchicine isolated from seeds along with stigmasterol, bakuchiol and psoralen. Isolation of two new benzofuron derivatives-corlifonol and isocorlifonol from seeds and their characterization in addition psoralen, bakuchiol, angelicin, corilifolicin, p-hydroxybenzoic acid isolated. Amino acids: It contains following amino acids Alanine, Arginine, Glycine, Histidin, Isoleucine and Lycine, Phenylealanine, Tryptophen. . Minerals: It also contains trace mineral like Magnesium, Calcium, Iron, Phosphorus and Potassium. The other important components are Aspartic acid, Beta-Carotine andGlutamic acid. Tyrosinase: The root of Psoralea contains Tyrosinase, an enzyme, which initiate the Oelanogenesis, in volume of about1.899 ppm.

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Drug Review Pharmacology &Therapeutic uses: It is a Kushthaghna, Kandughna, Jantughna, Vranashodhak, Vranaropak. It is antibacterial, antistaphylococcal, antifungal, anti-inflammatory, vasodilator, skin photosensitizing, antitumour, immunomodulatory, anticonvulsant, central muscle relaxant, mild hypotensive, spasmolytic, antipyretic. Clinical studies were conducted at several places to evaluate the effectiveness of Psoralia corylifolia seeds as well as its different chemical constituents in treatment of leucoderma. Local application of oleo-resinous extract of seeds on the patches of Leucoderma was found promising but oral administration of seeds was associated with severe undesirable side effects like nausea, vomiting, malaise, headache, and sometimes purging128. The transdermal product of psoralen may improve melanin formation in vitiligo patients. Topical application of active fraction from seeds inhibited the growth and delayed the onset of papilloma formation. Psoralene and isopsoralene are considered the therapeutically active constituents of the seeds. The drug appears to have a purely local action with a specific effect on the arterioles of the subcappilary plexuses which are dilated so that plasma is increased in this area. The skin becomes red and the melanoblasts are stimulated. In leucoderma, melanoblasts do not function properly and their stimulation by the drug leads them to form and exude pigments which gradually diffuse into the white leucodermic patches. The treatment by this drug has not been effective in the leucoderma of syphilitic group. Because in such cases probability melanoblasts are killed, as they are not visible in histological preparation

2) PARADA129
Vernacular Names: Samskrta Hindi Latin English Rasa Panchaka Rasa Guna Virya Vipaka Karma : : : : : Shad Rasa Snigdha, Sara, Guru Usna Madhura Yogavahi, Rasayana, Balya, Vrusya etc. : : : : Parada Parada Hydrargyrum Mercury, Quick silver

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COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Drug Review Dosha Prabhava Vyadhi Prabhava : : Tridosaghna Krmi,Kustha, Vataroga,Valipalita roga etc.

3) GANDHAKA130
Vernacular Names: English Nam : Sulphur, Brime Stone Sulphur Samskrta Hindi Synonyms Classification Uparasa varga Rasa Panchaka: Rasa Guna Veerya Vipaka Karma VyadhiPrabhava Doshaghnata Prabhava Dose Anupana :Katu, Tikta, Kashaya, Madhura. :Ushna, Snigdha, Sara. :Ushna. : Madhura. : Deepana, Pachana, Krimihara, Rasayana, Yogavahi. :Kandu,Kushta,Visarpa,Dadhru,Krimidosha. :Vatakapha Shamaka, Rakta Shodhaka :Twakavikaranashaka, Kushtanashaka. :Rasatarangini : 1-8 Ratti :Pakwa Kadalipatra in Skin disease Kitanasana,Kushtari, Pamari : Suvarnadi varga, Candanadi varga, Dhatu varga, : Gandhaka : Gandhaka

:Navanita, Gandhaka, Kruragandha, Kitaghna, Lekhi,

4) TAMRA131 :
Vernacular Names : Samskrta Hindi Latin English Rasa Panchaka: Rasa Guna Virya Vipaka : Tikta, kashaya, katu, madhura : laghu, sara : Usna : Madhura : Tamra : Tamba : Cuprum : Copper

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COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Drug Review Karma Vyadhi Prabhava : lekhana, ropan, shodhak. : visha, udara, aam, krumi, kustha.

B) Gomutra Ghana vati: ( Gomutrasava126,127)


Gomutra is claimed to be an elite effective medication in the cure of the shwitra particularly Gomutrasava .Palatability was the main drawback against acceptance of Gomutrasava so in the present study with the unique concept of Ghanakriya it was converted into Gomutra Ghana vati to rescue the issues related to adaptation of Gomutrasava. Following drugs are used to make kwatha later followed by Ghana Kriya. 1. Chitrak 2. Sunthi 3. Marich 4. Pippali 5. Gomutra 6. Water Indication Matra : : : : : : : : 1 Tola ( Mool ) 1 Tola ( Mool ) 1 Tola ( Fala ) 1 Tola ( Fala ) 1 Karsha (1 Karsha=1 Tola12 gram ) AFI 64 Pala Shwitra , Kushta . 1gm tid : (4 Tola = 1 Pala46gram) AFI

Method of Preparation

All the four dry herbs are collected in required quantity (1 tola12gram) AFI and grinded into coarse powder, Freshly collected 1 karsha Gomutra and 64 Pala water has to be added to above said mixture as per emphasized by Shadangdhara in Kashaya kalpana132.The mixture is kept on slow fire for Ghana kriya and Should be heated till it convert into solid and later Ghana vati is prepared. 1. CHITRAKA133: Botanical Name : Plumbago zeylanica Linn. Family : Plumbaginaceae Vernacular Names : Sanskrit : Chitraka Hindi : Chita Bengali : Chita English : Leadwort Gujarati : Chitro

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Drug Review Rasapanchaka /Pharmacodynamics : Rasa Guna Virya Vipaka Part Used : Katu : Laghu, Tikshna, Ruksha : Ushna : Katu : Root

Doshakarma : Kapha-vatashamaka, Deepana

Chemical Constituents : Roots contain an antimicrobial napthoquinone, plumbagin, sitosterol, sitosterol glycoside, tannin, glucose and organic acids. Aerial parts contain 6hydroxyplumbagin, plumbagin, sitosterol,stigmasterol and campesterol. Pharmacological action and studies : Roots are acrid and irritant and used as a local vesicant and abortifacient. They are used internally in the treatment of hepatitis, dyspepsia, piles, anasarca and both externally and internally in rheumatism, paralytic affections, enlarge glands and also in leucoderma. Roots are also a powerful sialogogue and a remedy for secondary syphilis and leprosy. Milky juice is useful in ophthalmia and scabies. Plumbagin has antifertility properties. Plumbagin showed anti bacterial activity against wide variety of bacteria (Ind. J. Exp. Biol. 1980, 18,876) 2. SHUNTHI134 Botanical Name Family Vernacular Names : Sanskrit : Shunthi, Hindi : Sontha Bengali : Sontha, Gujarati : Suntha English : Dry Ginger Rasapanchaka /Pharmacodynamics : Rasa Guna Virya Vipaka : Katu : Laghu, Snigdha : Ushna : Madhura : Zingiber officinale Rosc. : Zingiberaceae

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COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Drug Review Doshakarma : Kapha-vatashamaka Part Used : Dried rhizomes

Chemical Constituents: Rhizome contains acrid resinous substances,essential oil starch, protein and sugars. Resin contains a pungent principle, gingerol, gingeodiols and gingediacetates. Essential oil is a mixture of more than 25 different monoterpene and sesquiterpene compounds. Rhizome also contains zingerone, a pungent compound with sweet odour. Pharmacological action and studies: Rhizome constitutes the drug which is stimulant, carminative, stomachic, digestive, sialgogue and rubefacient. Infusion of rhizome is popularly used in the treatment of dyspepsia, vomiting, loss of voice, cough and cold with fever, sore throat, constipation, dysentery, earache and headache. It is also prescribed as an adjunct to many tonic and stimulating remedies. Gingerols active is Analgesic. Shogaol and gingerol were also analgesic in animals. The alcoholic extract showed some significant activity against E.coli (Gugnani. &Ezenwanze, 1985) 3. MARICHA135 : Botanical Name : Piper nigrum Linn Family : Piperaceae Vernacular Names : Sanskrit Hindi Bengali Gujarati English Rasa Guna Virya Vipaka : Katu : Laghu, Tikshna, Ruksha : Ushna : Katu : Maricha : Kali Mircha : Gol Maricha : Kala Mari : Black pepper

Rasapanchaka /Pharmacodynamics :

Doshakarma : Kapha-vatashamaka, Deepana

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COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Drug Review Part Used : Fruits

Chemical Constituents: Fruits contain alkaloids, chavicine, -methyl pyrroline, piperine, piperidine, piperovatine, a balsamic essential oil, apungent resin, chavicin, piperetine, lignin, gum, starch and fat. Volatile components of essential oil are mainly mono, sesquiterpenes, piperine, piperidine, depentine. Stems and leaves contain traces of the principal alkaloids. Pepper also contains oleoresin, gum and fatty oil. Pharmacological actions and studies: Fruits are pungent, carminative, antiperiodic, stimulant and rubefacient, and used in the treatment of colds, coughs, asthma, sore throat, skin diseases, cholera, obstinate fevers, dyspepsia, constipation, gastric troubles, ascites and anaemia and also for expulsion of worms. The fruits extract reported to be inhibitory to E.coli (subrahmanyam, 1957).

4. PIPPALI136 Botanical Name Family Vernacular Names : Sanskrit Hindi Bengali Gujarati Rasa Guna Virya Vipaka Part Used : Katu : Laghu, Tikshna, Snigdha : Ushna : Katu : Fruits : Gaja Pippali : Gaja Peepal : Gaj Pipul : Moti Peepar : Piper sylvaticum Roxb. : Piperaceae

Rasapanchaka /Pharmacodynamics :

Doshakarma : Kapha-vatashamaka

Chemical Constituents : Fruits contain a pungent resin, essential oil, starch, alkaloids, piperine, piplartine and two liquid alkaloids; triacontane, sesamin, dihydrostigmasterol, piplasterol, sesquiterpenes, glycosides and sugars. Stems contain alkaloids, piperine, piplartine, triacontane, dihydroxystigmasterol and a steroid. Roots AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 80
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Drug Review contain an alkaloid, piperlongumine. The pungent principle present in the fruit is capsaicin. Uses : Fruits possess stimulant, alterative, carminative and expectorant properties, and are used in the treatment of dyspepsia, colds, coughs, malaise and fever. Root is used in the treatment of headache and insomnia. Pharmacological actions and studies: Marked anti inflammatory activity is established against carrageenin induced rat paw edema (sharma and Singh, 1980). 5 GOMUTRA : Gana : Katuskandha137 Shirovirechana138 Rasa Panchaka Rasa Guna Virya Vipaka Dosha : Katu, Tikta, Kashaya, Madhura, Lavana (Anurasa) : Tikshna, Ushna, Laghu : Ushna : Katu : karma Kaphavata Shamaka, Pitta Prakopaka

Chemical Constituents: Table 20: showing Chemical description of cow urine and cure of diseases: S. No. 1 Name of chemical Nitrogen (N2) Pharmacological action Removes blood abnormalities and toxins, Natural stimulant of urinary track, activates Kidneys and it is diuretic. 2 3 4 5 Sulphur (S) Ammonia (NH3) Copper (Ca) Iron (Fe) Supports motion in large intestines. Cleanses blood. Stabilizes bile, mucous and air of body. Stabilizes blood formation. Controls built up of unwanted fats, decreases obesity. Maintains balance and helps in production of red blood cells and haemoglobin. Stabilizes working power of organs. AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 81
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Drug Review 6 7 8 9 10 11 12 13 14 15 Urea Co(NH2)2 Uric Acid Phosphate (P) Sodium (Na) Potassium (K) Manganese (Mn) Carbolic acid (HCOOH) Calcium (Ca) Salt (Nacl) Vitamins A,B,C,D,E Affects urine formation and removal. Germicidal. Removes heart swelling or inflammation. It is diuretic therefore destroys toxins. Helps in removing stones from urinary track. Purifies blood, antacid.
Cures hereditary rheumatism, increases appetite, removes muscular weakness and laziness.

Germicidal, protects decay due to gangrene. Germicidal, stops growth of germs and decay due to gangrene. Blood purifier, bone strengthener, germicidal. Prevents exhaustion, unconsciousness and toxicity, germicidal. Vitamin B is active ingredient for energetic life, saves from nervousness, strengthens bones and reproductive.

16 17 18 19 20 21 22

Other Minerals Lactose Enzymes Water (H2O) Hipuric acid Creatinin Aurum Hydroxide

Increases immunity. Gives satisfaction, Strengthens heart, removes thirst and nervousness. Makes healthy digestive juices, increases immunity. It is life giver. Maintains fluidity of blood, maintains body temperature. Removes toxins through urine. Germicide. It is germicidal and increases immunity power. AuOH is highly antibiotic and antitoxic.

Pharmacological actions and studies "gavyam sumadhuram kinchid doshaghnam krumi kushthanut kandunghana shamyet pitam samyak doshom vahe hitam"139 Mulakbeej avalguja lepa pishto gavam mut 140 AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 82
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Drug Review Its utilized in curing skin ailments has been stressed in this verse. In case of itching, boils, vicharchika cow urine mixed with amba haldi should be taken. In case of skin disease, Make a paste of mixture of Hartal, Bakuchi and Malankangani in cow urine and apply over the diseased part of skin. In case of white leprosy apply paste of Bakuchi seed powder in cow urine. In case of ear pain and other diseases drops of warm cow urine may be put in ear. In case of itching take massage and bath with cow urine. Mix powdered krishna jiraka with cow urine and use this for massage then take cow urine bath, it cures all skin diseases. Electric rays present in environment keep our body healthy. Copper has property of attracting these electric rays to enter in our body in form of extremely small current; we can get copper from cow urine. Under the Ayurvedic treatment of leprosy and skin Disease, both chalmogra oil extracted from the seeds and cow urine are prescribed for internal as well as external use. As the Scientist J.C.Ghosh states it is very likely that the acids of the oil coming in contact with the sodium and ammonium salts of urine some alkaline salts are formed and these salts being soluble .they will readily diffuse through the patients blood, and act as if a soluble salt of chalmogra acids were administered to the patients. The chief active principle of seeds is an essential oil. On voluntary muscles, the essential oil in high dilutions has a distinct stimulant action. The essential oil however varies enormously in its effects on different patients. With the majority of the patients it causes only redness of the leucodermic patients.

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Figure No 01 Ingredients of Shashilekha Vati

PARADA

GANDHAKA

TAMRA BHASMA

BAKUCHI SEED

Figure No 02 Final Product - Shashilekha Vati

SHASHILEKHA VATI

MARKET PACK

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Figure No 03 Ingredients of Gomutra Ghana Vati

CHITRAKA

MARICH

GOMUTRA

PIPPALI

SHUNTHI
Figure No 04 Final product Gomutra Ghana Vati

GOMUTRA GHANA VATI

MARKET PACK

Figure No 05 Market pack -Bakuchi Taila:

MARKET PACK - BAKUCHI TAILA

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AnalyticalStudy

ANALYTICAL STUDY
Analytical Study of Shashilekha vati : For routine analysis and standardization of Shashilekha vati, HPTLC finger print profile of Shashilekha vati has been obtained in comparison with Bakuchi in a suitable solvent system. When the plate viewed under 254 nm HPTLC finger prints of Bakuchi and Shahilekha vati showed 13 and 6 spots respectively. The Rf values of four spots (0.51, 0.69, 0.75, 0.82- all Green) of Shahilekha vati is comparable with that of Bakuchi. , Thus presence of Bakuchi in Shashilekha vati has been established by HPTLC fingerprinting. Gas Chromatography Mass Spectrometry profile of Shashilekha vati has been obtained for amenable steroids or anti-nutritional value as per the library of the instruments. This analysis did not reveal presence of any of the pesticides as well as steroids. Analytical Study of Gomutra Ghana Vati: For routine analysis and standardization of Gomutra Ghana Vati, Microbial load analysis of Gomutra Ghana vati was carried out as Gomutra is used as main ingredient which had ruled out contamination. HPTLC finger print profile of Gomutra Ghana Vati (GGV) was done for comparing the sample to its ingredients viz. chitraka (C), Marica (M) and Shunthi (S). HPTLC of Photodocumentation revealed spots of the same Rf and color as that of ingredients in GGV. When chromatograms were obtained under UV 254 and 366 nm at equal concentration of ingredients and triple the concentration of GGV, the chromatogram of GGV was superimposable with each ingredient. Gas Chromatography Mass Spectrometry profile of Gomutra ghana Vati has been obtained for amenable pesticides as keeping eagle eye on Gomutra may contain pesticides as Cow usually eats farm crops which may be sprinkled with pesticides. This analysis did not reveal presence of any of the pesticides as well as steroids. Detailed reports are piled up in coming pages respectively.
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||Om Shri Manjunathaya Namaha|| S.D.M. CENTRE FOR RESEARCH IN AYURVEDA AND ALLIED SCIENCES (AYUSH Centre for Excellence and Recognized SIROs by DSIR) Laxminarayana Nagar, P.O. Kuthpady 574 118 UDUPI [Karnataka] Ph. 0820 2533971 E-mail: gravishankar2000@yahoo.com ANALYSIS REPORT FOR 236/13032701-02

Part A: Particulars of sample submitted

Test requested by: Dr.Bhavin, SDMCA, Udupi. Requested on: 27-03-13 Investigation to be performed: HPTLC Sample coded as: 13032701-02 Sample details: Shashilekha vati and bakuchi. Packing details: Packed in plastic pouch.

Part B: Methodology

I.

HPTLC: Alcohol extract of sample was applied on a pre-coated silica gel F254 on aluminum plates to a band width of 8 mm using Linomat 5 TLC applicator. The plate was developed in Toluene: Ethyl acetate (7 : 3). The developed plates were visualized in UV 254, 366, under white light and then derivatised with vanillin sulphuric acid reagent and scanned under UV 254, 366 nm and under white light. Rf, colour of the spots and densitometric scan were recorded.

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Figure 1. TLC photo documentation of alcohol extract of Shashilekha vati

1234 At 254 nm

1234 At 366 nm Track 1- Bacuchi 5 l Track 2- Shashilekha vati 5 l Track 3- Bacuchi 10 l Track 4- Shashilekha vati 10 l

1234 Under white light

1234 Post derivatisation

Solvent system- Toluene: Ethyl acetate (7:3)


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Table 1. Rf values of both tracks At 254 nm Bacuchi Shashileka vati 0.04 Green 0.14 Green 0.20 Green 0.25Green 0.31 D green 0.36 D green 0.47 D green 0.51 Green 0.55 Green 0.64 Green 0.69 Green 0.75 Green 0.82 Green 0.17 Green 0.51 Green 0.69 Green 0.75 Green 0.82 Green 0.97 Green 0.02 F yellow 0.04 F blue 0.14 F blue 0.20 F blue 0.25 F blue 0.36 F blue 0.47 F blue 0.61 F blue 0.69 F blue 0.75 F blue 0.86 F blue 0.93 F blue At 366 nm Bacuchi Shashileka vati 0.02 F blue 0.04F blue 0.14 F blue 0.20 F blue 0.25 F blue 0.36 F blue 0.47 F blue 0.64 F blue 0.69 F blue 0.79 F blue 0.96 F black 0.04 Black 0.17 Yellow 0.25 L blue 0.37 Blue 0.47 D yellow 0.55 Blue 0.64D green 0.73 Blue 0.82 D blue 0.88 Purple Post derivatisation Bacuchi Shashileka vati 0.17 L blue 0.47 L yellow 0.55 L blue 0.64 L blue 0.82 L blue -

D- Dark; L- Light; F- fluorescent

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Figure 2. HPTLC densitometric scan of alcohol extract of at 254 nm

Bacuchi 5 l

Shashilekha vati 5 l

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Figure 3. HPTLC densitometric scan of alcohol extract at 366 nm

Bacuchi 5 l

Shashilekha vati 5 l

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Figure 4. HPTLC densitometric scan of alcohol extract under white light

Bacuchi 5 l

Shashilekha vati 5 l

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Figure 5. 3 D display of both tracks

At 254 nm

At 366 nm

Under white light

Part D: Remarks HPTLC finger print profile of Shashilekha vati has been obtained in comparison with bakuchi in a suitable solvent system. The TLC photo documentation, Rf values and densitometric scan have been developed. When the plate viewed under 254 nm HPTLC finger prints of bakuchi and Shahilekha vati showed 13 and 6 spots respectively. The Rf values of four spots (0.51, 0.69, 0.75, 0.82- all Green) of Shahilekha vati is comparable with that of bakuchi. HPTLC finger print of Shahilekha vati under 366 nm showed 11 spots. The Rf values 0.02, 0.04, 0.14, 0.24, 0.25, 0.36, 0.47 and 0.64 are present in both Shahilekha vati and bakuchi. Colour of all the spots are F blue except the spot with Rf value 0.02 (F yellow).

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After derivatisation with vanillin sulphuric acid bakuchi showed 10 spots and Shashilekha vati showed only 5 spots. The spots with Rf values 0.17, 0.47, 0.55, 0.64 and 0.82 are present in both sample. Thus the presence of bakuchi in Shashilekha vati has been established by HPTLC fingerprinting. The identity test can be used for routine analysis and standarisation of Shashilekha vati.
Testing Personnel Laboratory In-charge Authorized Signatory

M Rajalekshmi. M.Pharm. Research Officer Pharma Chemistry

KN Sunil Kumar M.Sc., (Ph.D.) Senior Research Officer Pharmacognosy

Dr. B Ravishankar M.Sc., Ph.D. Director

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||OhmShreeManjunathayaNamaha|| S.D.M.CentreforResearchinAyurveda AndAlliedSciences (AYUSHCentreforExcellenceandRecognizedSIROsbyDSIR) LaxminarayanaNagar,P.O.Kuthpady574118 Udupi[Karnataka] Ph.08202533971Email:gravishankar2000@yahoo.com


Part A: Particulars of sample submitted TEST TITLE: Microbial load analysis of Gomutra Ghana vati. Test sample: Gomutra Ghana vati Shape: Round Colour: Black Odour: Gomutra Sample Code: 2030301 Sample presentation: Polythene bag unsealed.

Part B: Methodology Preparation of Casein soya bean digest agar medium (CSDAM): The following ingredients Casein peptone 7.0g, Soya peptone 2.5g, sodium chloride 2.5g were taken and dissolved in distilled water and made up to 500 ml and pH was adjusted to 7.30.2 with Sys 361 Systronics digital pH meter. 7.0g of agar was added and mixed. Then media was autoclaved at 121 C for 20 minutes. Preparation of buffered Sodium chloride peptone solution (BSCPS) pH 7.0: The following chemicals Potassium dihydrogen phosphate 1.78g, Disodium hydrogen phosphate 3.615g, Sodium chloride 2.15g, Peptone 0.5g were taken and dissolved in distilled water and made up to 500 ml. Then pH was adjusted to 7.0 with Sys 361 Systronics digital pH meter. Total aerobic microbial count by plate count method: Serially dilute the sample under test in sterile BSCPS. 1 g of the sample was mixed with 10 ml of sterile BSCPS to make dilution 10-1. 1 ml from 10-1 dilution is transferred to 9 ml of sterile BSCPS to make a dilution of 10-2. Similarly a dilution 10-3 was carried out. A petri dish of measurement of 10cm in diameter is taken and 1 ml (inoculam) each dilution was introduced into sterile petri dishes. Molten media (CSDAM) cooled to 45C is and poured into petri dishes containing the specified amount of sample. Following the addition of molten and cooled agar, the cover is replaced and the plate is gently rotated in a circular motion to achieve uniform distribution of the sample. This is left undisturbed till the media solidifies. Solidified media was transferred to the BOD incubator. Plates were incubated at 30C for 5 days. Number of colonies was counted using digital colony counter.

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Part C: Results Table No.1. Sl.No.


1 2 3

Dilutions
1/10 (10-1) 1/100 (10-2) 1/1000 (10-3) 21 01 01

Number of Colonies (NOC)


02 02 02 13 03 03

CFU/g
1 0 0

Trial 1; 2Trial 2; 3Trial 3, CFU-Colony Forming Units.

Above results shows that, test sample is highly sterile hence profuse growth of bacterial colonies were not observed. Higher dilutions do not produced any bacterial colonies. Whereas lower concentration / dilution produced minimum number of colonies. Colony forming units in this test drug is found to be lesser than the permissible limit as per WHO guidelines (Anonymous, 1998.). CONCLUSION: Test drug Gomutra Ghana vati is free from contamination.

Testing Personnel

Laboratory In-charge

Authorized Signatory

Mrs. Shalini, DMLT Lab Technician Microbiology

Dr.Devika Shetty, M.Sc., Ph.D.) Senior Research Officer Biotechnology and Microbiology

Dr. B Ravishankar M.Sc., Ph.D. Director

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SDM CENTRE FOR RESEARCH IN AYURVEDA AND ALLIED SCIENCES, LAXMI NARAYANA NAGAR, KUTHPADI, UDUPI - 574 118
TEST SAMPLE CODE: 89.12030301 and 95.12031001 Part A: Particulars of sample submitted

Test requested by: SDM Pharmacy Udupi Test requested on: 03-03-12 and 10-03-12 Investigation to be performed: HPTLC Sample coded as: 12030301 and 12031001 Sample details: Gomutraghanavati and its ingredients Packing details: Packed in polythene cover. Part B: Methodology

Figure 1. TLC PHOTODOCUMENTATION OF ALCOHOLIC EXTRACT OF GOMUTRAGHANA VATI AND ITS INGREDIENTS

1234

1234 1234 At UV 254 nm At UV 366 nm Post derivatisation Track 1 - Chitraka 10 l Track 2 - Maricha 10 l Track 3 - Sunthi10 l Track 4 - Gomutraghana vati 30 lSolvent system - Toluene : Ethyl acetate (9: 2)

HPTLC: As per SOP: SDMCRAAS/PCHE/018

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Table 1. Rf value of alcoholic extract of gomutraghana vati (30 l) and its ingredients

Chitraka (C) 0.03 L Green 0.37 L Green -

Maricha (M) Sunthi (S) 0.07 L Green 0.10 L Green 0.19 L Green 0.24 D Green 0.27 L Green 0.29 D Green 0.31 Green 0.39 D Green 0.47 D Green 0.54 L Green 0.59 L Green 0.64 L Green 0.70 L Green 0.75 Green 0.96 Green 0.96 Green (10 l) at UV 254nm L- Light , D- Dark

Gomutraghana vati 0.03 L Green (C) 0.10 L Green (M) 0.13 L Green 0.24 D Green (M) 0.29 D Green (M) 0.31 Green (M) 0.39 D Green (M) 0.47 D Green (M) 0.54 L Green (M) 0.59 L Green (S) 0.64 L Green (S) 0.75 Green (M) 0.96 L Green (S)

Table 2. Rf value of alcoholic extract of gomutraghana vati (30 l) and its ingredients (10 l) at UV 366nm
Chitraka (C) 0.36 F L Green 0.85 F Blue Maricha (M) 0.08 F L Blue 0.14 F L Brown 0.17 F L Brown 0.24 F Blue 0.27 F Blue 0.33 F L Blue 0.42 F L Blue 0.46 F L Blue 0.53 F L Brown 0.64 F L Blue 0.74 F M Blue 0.85 F Blue Sunthi (S) 0.60 F Green 0.85 F Blue 0.97 F L Blue Gomutraghana vati 0.03 F L Blue 0.08 F L Blue (M) 0.17 F L Blue (M) 0.24 F Blue (M) 0.27 F M Blue (M) 0.33 F Green (M) 0.42 F L Blue (M) 0.48 F L Green 0.53 F L Blue (M) 0.60 F L Blue 0.64 F L Blue (M) 0.68 F L Blue 0.74 F L Blue (M) 0.85 F Blue (M & S) 0.97 F L Blue (S)

F- Fluroscent, L- Light, M- Medium, D- Dark

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Table 3. Rf value of alcoholic extract of gomutraghana vati (30 l) and its ingredients (10 l) after derivatisation in vanillin-sulphuric acid
Chitraka (C) 0.22 L Blue 0.38 L Green 0.45 L Blue 0.98 L Blue Maricha (M) 0.07 L Blue 0.12 L Blue 0.26 Brown 0.29 Brown 0.38 L Pink 0.41 L Pink 0.45 L Blue 0.54 L Pink 0.68 L Blue 0.75 Purple 0.95 Blue Sunthi (S) 0.03 Purple 0.07 Blue 0.12 Blue 0.26 Blue 0.31 Blue 0.33 Blue 0.45 Blue 0.48 Blue 0.60 Purple 0.63 Brown 0.95 Blue Gomutraghana vati 0.03 L Blue 0.07 L Blue (M / S) 0.12 L Blue (M / S) 0.26 Brown (M) 0.29 Brown (M) 0.31 Blue (S) 0.35 Blue 0.38 Blue (C / M) 0.41 Blue 0.45 Blue (C / M) 0.54 Blue 0.60 Purple (S) 0.63 Blue 0.68 L Blue (M) 0.75 L Purple (M) 0.98 Blue (C)

L- Light

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Figure 2. HPTLC Densitometric scan of gomutraghana vati (30 l) and its ingredients(10 l) at UV 254nm

Chitraka

Maricha

Sunthi

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Gomutraghana vati
Figure 3. HPTLC Densitometric scan of gomutraghana vati (30 l) and its ingredients(10 l) at UV 366 nm

Chitraka

Maricha

Sunthi

Gomutraghana vati

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Figure 4. 3D display of tracks At UV 254nm

At UV 366nm

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Part D: Remarks HPTLC of gomutraghanavati (GGV) was done for comparing the sample to its ingredients viz. citraka (C), marica (M) and sunthi (S). Photodocumentation revealed spots of the same Rf and color as that of ingredients in GGV. Under UV 254 nm there were 2 spots in C, 11 spots in M and 5 spots in S. Out of 13 spots present in GGV, 10 spots were from M and 2 from S. At UV 366 nm there were 2 spots in C, 12 spots in M and 3 spots in S. Out of 15 spots present in GGV, 10 spots were from M and 2 from S. After derivatisation there were 4 spots in C, 11 spots in M and 11 spots in S. Out of 16 spots present in GGV, 2 were either from C or M, 2 from M or S, 4 from M and 2 from S. When chromatograms were obtained under UV 254 and 366 nm at equal concentration of ingredients and triple the concentration of GGV, the chromatogram of GGV was superimposable with each ingredient. In the solvent system used, most of the spots in GGV were from P.

Testing Personnel Trainee Research Officer Laboratory In-charge Authorized Signatory Director

Senior Research Officer

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Methodology

MATERIALS AND METHODS


Aims and Objectives of the Study:
To study nidana panchaka of Shwitra according to Ayurvedic texts in detail. To critical analysis of literature for the different clinical aspects of Shwitra and study Vitiligo in Modern medicine in detail. To assess the role of Shashilekha vati along with Gomutra Ghana vati internally and Bakuchi Taila as topical application in Shwitra.

Source of Data:
20 patients with a definite diagnosis of Shwitra/Vitiligo fulfilling the diagnostic, inclusion and exclusion criteria were selected for the study irrespective of their sex, caste and religion from the OPD and IPD of SDM Ayurveda hospital. These patients were recruited for the study after getting a written consent.

Methods of Collection of Data:


A special proforma was prepared incorporating all the clinical manifestation and assessment criteria including ancillary investigation findings of the Vitiligo / Shwitra. Complete clinical data was collected from all the selected patients as per the proforma before the intervention. Results obtained were statistically analyzed by adapting the paired t test.

Design of Study:
It was an open explanatory clinical study with pre-test and post-test design.

Intervention: Following oral medications are given for 56 days Shashilekha vati - 125 mg. tid (a.c.)
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Methodology

Along with Anupan- Bakuchi Tail 1 Karsha(10-12 ml) + Madhu Gomutra ghan vati 1 gm tid (a.c.)

Duration of the Study: 28 days of medication followed by another 28 days of follow up

Diagnostic Criteria:
Must have Pratyatma Lakshana of Shwitra i.e. visible depigmented lesion.

Inclusion Criteria:
Patients fulfilling the criteria of diagnosis irrespective of sex or creed. Patients between the ages of 16 to 70 years.

Exclusion Criteria:
Chronicity more than 10 years. Spread more than 50 % of the body involvement. Patient with any other systemic illness like diabetes mellitus, IHD etc.

Investigations:
Blood- TC, DC, ESR, HB%,RBS

Assessment Criteria:
1) Subjective parameters: Sympotms of Switra as well as Vitiligo explained in ayurvedic and modern texts respectively were the subjective parameters such as: 1. Twak shwethata whitish discolouration with complete dipigmented skin
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Methodology
Grade 0 normal normal skin colour Grade 1 mild less pigmentation and more pigmentation over a lesion Grade 2 - moderate depigmentation more than pigmentation or equal over lesion Grade 3 severe no pigmentation totally white colour over lesion 2. Arun varnata : Grade 0 normal normal skin colour Grade 1 mild less aruna varnata and more pigmentation Grade 2 - moderate more aruna varnata than normal colour or equal over lesion Grade 3 severe totally aruna varna over the lesion 3. Tamra varnata : Grade 0 normal normal skin colour Grade 1 mild less tamra varna and more pigmentation Grade 2 - moderate more tamra than normal colour or equal over lesion Grade 3 severe totally tamra varnata over the lesion 4. Twak rukshta : Grade 0 normal no dryness Grade 1 mild dryness on exposure to cold and sunlight and other allergents Grade 2 - moderate dryness during exposure to cold environnment Grade 3 severe always dryness 5. Daha : Grade 0 normal no burning sensation Grade 1 mild burning sensation on expose to mid noon sunlight Grade 2 - moderate burning sensation morning sunlight exposure and other iritants Grade 3 severe always burning sensation 6. Roma vivarnata : Grade 0 normal normal hair colour Grade 1 mild less than 25% of hair over the lesion has vivarnata
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Methodology
Grade 2 - moderate 25% - 75% of hair over the lesion has vivranata Grade 3 severe more than 75% of hair over the lesion has vivarnata 7. Kandu : Grade 0 normal no itching Grade 1 mild itching on exposure to cold and sunlight and other allergants Grade 2 - moderate itching on exposure to mild cold environment Grade 3 severe always itching

Vida score (Vitiligo disease activity score) :


The Vitiligo Disease Activity (VIDA) Score is a 6-point scale for assessing Vitiligo activity. It helps in assessing effectiveness of interventions to halt and reverse the extention of depigmentation.

Scoring
Based on the individual's own opinion of the present disease activity over time. Active Vitiligo involves either one of the following aspects:

(1) Expansion of existing lesions or


(2) Appearance of new lesions.

Table 21: VIDA scoring :

Vitiligo Activity Active Active Active Active Stable Stable with spontaneous repigmentation

Time Period 6 weeks or less 6 weeks to 3 months 3 - 6 months 6 - 12 months 1 year or more 1 year or more

VIDA Score +4 +3 +2 +1 0 -1

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Methodology
OBJECTIVE PARAMETERS: Scoring Pattern Special scoring pattern was adopted for scrutinizing the symptomatology. The score was given on the basis of size, color, number and percentage of area involvement. For the assessment of the involvement of body surface area, the Rule of Nine described in the forensic medicine was used with certain modifications. The whole body was scored as per the rule of nine explained in text, but looking to the nature of the disease, score was further specified to the organs as follows

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Table 22: Body Surface area using rule of 9:


Involved body part Head and neck Scalp Face Neck Thorax Dorsal Ventral Abdomen Trunk Back One Upper limbs Finger to elbow Dorsal Ventral Elbow to shoulder Dorsal Ventral One lower limb Finger to knee Dorsal Ventral Knee to leg Dorsal Ventral Perineal part 4.5 4.5 1.0 1.0 4.5 4.5 R 9 L 9 9 9 2.25 2.25 R L 36 4.5 4.5 2.25 2.25 R 4.5 L 4.5 Percentage 2.0 5.0 2.0 9.0 9.0 9.0 9.0 18 18 18 18 Subtotal Total 9

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Methodology

The criteria kept for grading to observe any improvement was as following.

1) Percentage of Body region involvement: Total % of area involved 0 Less than 2 % 2-5% 5-20% 20-50% Score 0 1 2 3 4

2) Number of patches: Number of patches 0 1 to 3 4 to 6 7 to 10 More than 10 or Descrete lesion Score 0 1 2 3 4

3) Colour change in the observed Shvitra patches: Color Normal Red Pinkish Redish white White Score 0 1 2 3 4

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4) Size of the observed Shvitra patch : Size 0 cm Less than 2 cm 2 to 5 cm 5 to 10 cm More than 10 cm Score 0 1 2 3 4

5) Number of black spots in observed Shvitra patch : Number of black spots If no black spots appear If less than three spots appear If three or more spots appear Score 2 1 0

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Observation OBSERVATION A total of 20 patients suffering from Shwitra were taken for the study who fulfilled inclusion criteria. All patients registered have completed the stipulated period of the study. All the patients irrespective of their sex and caste were taken for the study and were given with the trial drug.

The statistical analysis, observations and the result of the study are elaborated as follows: 1. Descriptive statistical analysis of the patients. 2. Analysis of the therapeutic effect of the Shashilekha vati and Gomutra Ghana vati in the patients suffering from Shwitra and the significance of the treatment is assessed by using Pairedt test.

Descriptive Statistical Analysis The descriptive statistical analysis of 20 patients of Shwitra and distribution of the patients according to their Age, Gender, Marital status, Dietary habits, Prakriti, Satva etc is elaborated in coming pages.

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Observation Distribution of 20 Patients According to Different Age group: Out of 20 Patients of Shwitra in this study maximum number of 5 (25%)patients belonged to the age group 31-40 years against minimum number of 1 (5 %)patients in age group 61-70 Years.The details are given in Table No.23 and Graph No.1

Table no.-23 Distribution of Patients According to Age group Age (in years) 16-20 21-30 31-40 41-50 51-60 61-70 No. of Patients 4 3 5 4 3 1 % 20% 15% 25% 20% 15% 5%

Graph no.-1 Distribution of Patients According to Age group

AGE
1620 2130 3140 5% 15% 20% 25% 20% 15% 4150 5160 6170

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Observation Distribution of Patients According to Gender: There were 14(70%) male patients suffering from the Shwitra as against the 6 (30%) of female patients were present in the study.The statistical elaboration of the details is shown in the table (Table no. 24) and pie diagram (Graph no.-2)

Table no.-24 Distribution of Patients According to gender Gender Male (M) Female (F) No. of Patients 14 6 % 70% 30%

Graph no.-2 Distribution of Patients According to gender

GENDER
MALE FEMALE

30%

70%

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Observation

Distribution of 20 Patients According to Religion Out of 20 Patients 85% of Patients were Hindus; Muslims and Christians were 5% and 10% respectively. The same is detailed in the table (Table no. 25) and pie diagram (Graph no.-3).

Table No.-25 Distribution According to Religion Religion Hindu (H) Muslim (M) Christian (Ch) No. of Patients 17 1 2 % 85% 5% 10%

Graph no.-3 Distribution According to Religion

RELIGION
HINDU 5% MUSLIM 0% 10% CHRISTIAN

85%

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Observation

Distribution of 20 Patients According to Educational Status Majority of Patients comprising 75 % in this group are Graduated followed by Higher Secondary class education contributing 20%. The complete details of the distribution of Patients According to education is detailed in the table (Table no. 26) and pie diagram (Graph no.-4)

Table No.-26 Distribution According to Educational Status Education Uneducated (UE) Primary school (P) Higher secondary (HS) Graduation (GR) Post-graduation (PG) No. of Patients 0 1 4 15 0 % 0% 5% 20% 75% 0%

Graph no.-4 Distribution According to Educational Status

EDUCATION
PRIMARY HIGHERSECONDARY 5% 20% GRADUATE

75%

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Observation

Distribution of Patients According to Habitate: There were 15(75%) of patients from urban domain as against the 5 (25%) of patients were from rural domain in the study.The statistical elaboration of the details is shown in the table (Table no. 27) and pie diagram (Graph no.-5)

Table no.-27 Distribution of Patients According to Habitate Habitate Urban Rural No. of Patients 15 5 % 75% 25%

Graph no.-5 Distribution of Patients According to Habitate

HABITATE
URBAN RURAL

25%

75%

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Observation Distribution of 20 Patients According to Occupation Maximum numbers of Patients were housewives and employee, each group contributing 30%. The distribution of 20 Patients According to their occupation is shown in the table (Table no. 28) and pie diagram (Graph no.-6) below.

Table no.-28 Distribution According to Occupation Occupation Student Housewife Employee Business man No. of Patients 5 6 6 3 % 25% 30% 30% 15%

Graph no.-6 Distribution According to Occupation

OCCUPATION
STUDENT HOUSEWIFE EMPLOEE BUSINESSMAN

15%

25%

30% 30%

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Observation Distribution of 20 Patients According to Socio- Economic Status Majority of Patients 14 (70%) belonged to the Middle class , 4(20%)were in upper middle class. The distribution of Patients According to Socio-Economic Status is given in table (Table no. 29) and pie diagram (Graph no.-7)

Table No.-29 Distribution According to Socio- Economic Status: Socio-Economic Status Lower class(L) Lower middle class(LM) Middle class (M) Upper middle class(UM) Upper class(U) No. of Patients 1 1 14 4 0 % 5% 5% 70% 20% 0%

Graph no.-7 Distribution According to Socio- Economic Status

SOCIOECONOMICSTATUS
LOWERCLASS UPPERMIDDLE 20% LOWERMIDDLE UPPER 0% CLASS 5% MIDDLE

5%

70%

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Observation Distribution of 20 Patients According to Marital Status 55% of Patients were married in contrast to 45% of Unmarried individuals in the present sample. The marital status of the 20 Patients is shown in the table (Table no. 30) and pie diagram (Graph no.-8)

Table No.-30 Distribution According to Marital Status Marital Status Married(M) Unmarried (UM) Divorce (D) Widow(W) No. of Patients 11 9 0 0 % 55% 45% 0% 0%

Graph no.-8 Distribution According to Marital Status

MARITALSTATUS
UNMARRIED 0% MARRIED

45% 55%

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Observation Distribution of Patients According to Ahara Out of 20 Patients, 10 (50%) had the habit of taking vegetarian diet and other 10(50%) had habit of taking mixed diet. Complete details of the same is given in the table (Table no. 31) and pie diagram (Graph no.-9)

Table No.-31 Distribution of Patients According to Ahara Ahara Vegetarian Mixed No. of Patients 10 10 % 50% 50%

Graph no.-9 Distribution of Patients According to Ahara

AHARA
VEGETARIAN MIXED

50%

50%

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Observation Distribution of Patients According to Vyasana 60 % of the Patients confessed the different addictions they had and the remaining 40% Patients had no history of any addictions. Table (Table no. 32) and pie diagram (Graph no.-10) show more details of the addictions in 20 Patients of Shwitra.

Table No.-32 Distribution According to Vyasana Vyasana Smoking Alcohol None No. of Patients 3 9 8 % 15 45 40

Graph no.-10 Distribution According to Vyasana

VYASANA
SMOKING ALCOHOL NONE

15% 40%

45%

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Observation Distribution of Patients According to Prakruti A majority of Patients belonged to Pitta Kapha Prakruti (40%) and 35% belonged to Vata kapha Prakruti. The details of other incidence are shown in the table (Table no. 33) and pie diagram (Graph no.-11).

Table No.-33 Distribution of Patients According to Prakruti

Prakruti Vata Pitta Kapha VataPitta VataKapha PittaKapha

No. of Patients 0 0 1 4 7 8

% 0% 0% 5% 20% 35% 40%

Graph no.-11 Distribution of Patients According to Prakruti

PRAKRUTI
VATA 0% PITTA 0% KAPHA VATAPITTA 5% 40% 20% PITTAKAPHA KAPHAVATA

35%

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Observation Distribution of Patients According to Samhanana Among the 20 Patients, 18(90%) recorded Madhyama Samhanana ; 2(10%) Patients showed Avara Samhanana. Table (Table no. 34) and pie diagram (Graph no.-12) depict more details of the same.

Table No.-34 Distribution of Patients According to Samhanana

Samhanana Pravara Madhyama Avara

No. of Patients 0 18 2

% 0% 90% 10%

Graph no.-12 Distribution of Patients According to Samhanana

SAMHANANA
AVARA MADHYAMA PRAVARA 0% 10%

90%

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Observation Distribution of Patients According to their Satva The assessment of the Satva in 20 Patients ; 10(50%)Patients having Madhyama Satva. Another 8(40%) patients had Avara Satva. Remaining 2(10%) Patients had Pravara Satva. The details of the Satva in this sample is depicted in the table (Table no. 35) and pie diagram (Graph no.-13). Table No.-35 Distribution of Patients According to their Satva Satva Pravara Madhyama Avara No. of Patients 2 10 8 % 10% 50% 40%

Graph no.-13 Distribution of Patients According to their Satva

SATVA
PRAVARA MADHYAMA AVARA

10% 40%

50%

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Observation Distribution of Patients According to Satmya Analysis of Satmya revealed that 75 % had Madhyama Satmya, 25% had of Avara Satmya and no one exhibited Pravara Satmya. The table (Table no. 36) and pie diagram (Graph no.-14) show the details of the same.

Table No.-36 Distribution of Patients According to Satmya Satmya Pravara Madhyama Avara No. of Patients 0 15 5 % 0% 75% 25%

Graph no.-14 Distribution of Patients According to Satmya

SATMYA
MADHYAMA AVARA

25%

75%

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Observation Distribution of Patients According to Ahara Abhyavaharana and Jarana Shakti 10% Patients had Pravara - Abhyavaharana and Jarana Shakti, 55% had Madhyama Abhyavaharana and Jarana Shakti and 35 % had Avara - Abhyavaharana and Jarana Shakti. Distribution of the Patients According to Abhyavaharana Shakti and Jarana shakti is shown in the table (Table no. 37) and pie diagram (Graph no.-15).

Table No.-37 Distribution of Patients According to Ahara- Abhyavaharana and Jarana Shakti Aahaara-Abhyavaharana Shakti Pravara Madhyama Avara 2 11 7 10% 55% 35% No. of Patients %

Graph no.-15 Distribution of Patients According to Ahara- Abhyavaharana and Jarana Shakti

AHARAABHYAVARANAANDJARANA SHAKTI
PRAVARA MADHYAMA 10% AVARA

35% 55%

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Observation Occurrence of Symptoms in 20 Patients of Shwitra The symptoms like Twaka Swetata was observed in 12(60%) Patients , Rukshta in 12(60%) of Patients and Tamra varnata in 7(35%). More details of the same is depicted in the table (Table no. 38) and bar diagram (Graph no.-16)

Table No.-38 Occurrence of Symptoms of Shwitra Symptamatalogy Twak Shwethata(TSw) Arun Varnata(AVr) Tamra Varnata(TVr) Twak Rukshta(TRuk) Daha(D) Roma Vivarnata(RVi) Kandu(K) No. of Patients 12 1 7 12 2 3 3 % of Patients 60% 5% 35% 60% 10% 15% 15%

Graph no.-16 Occurrence of symptoms of Shwitra

12 10

No. of Patients 6
4 2 0 TSw Avr TVr Truk D Rvi K

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Observation

Nidana of Shwitra identified in 20 Patients The exploration of Nidana in 20 Patients suffering from Shwitra revealed that 80%

of Patients exhibited faulty dietetic habits. Another 35% Patients showed erroneous Vihara as cause of the illness. Mere 5 % of Patients exhibited Manasika factor as Nidana. Details of the same is given in the table (Table no. 39) and bar diagram (Graph no.-17)

Table No.-39 Nidana of Shwitra identified in 20 Patients Nidana Aharaja(A) Viharaja (V) Manasika (M) No. of Patients 16 7 1 % 80% 35% 5%

Graph no.-17 Nidana of Shwitra identified in 20 Patients

16 14 12

No. of 10 Patients 8
6 4 2 0 AHARAJA VIHARAJA MANASIKA

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Observation Distribution as per Manobhava identified in 20 Patients of Shwitra The exploration of Manobhava in 20 Patients suffering from Shwitra revealed that 45% of Patients exhibited Chinta. Another 40% Patients showed Shoka. Mere 30 % of Patients exhibited Manasika factor like Bhaya. Details of the same is given in the table (Table no. 40) and bar diagram (Graph no.-18)

Table No.-40 Manobhava identified in 20 Patients of Shwitra Manobhava Chinta (C) Bhaya (B) Shoka (S) Krodha (K) No. of Patients 9 6 8 3 % 45% 30% 40% 15%

Graph no.-18 Manobhava identified in 20 Patients of Shwitra

10 8

No. of Patients

6 4 2 0 C B S K

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Observation Incidence of Number of patches in 20 Patients of Shwitra Out of 20 patient taken for clinical trial, Incidence shows that 10 subjects (50%) were having about 1-5 patches; 6 subjects (30%) were having about 6-10 patches,rest 4 subjects (20%) were having more than 10 patches. Details of the same is given in the table (Table no.41) and bar diagram (Graph no.-19)

Table No.41 : Showing incidence of Number of patches Shwitra No. Of Patches 1-5 6-10 Above 10 No. of Patients 10 6 4 % 50% 30% 20%

Graph no.-19 Showing incidence of Number of patches Shwitra

10 8

No. of 6 Patients
4 2 0 1 -5 6 - 10 Above 10

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Observation Incidence of colour of patches in 20 Patients of Shwitra Out of 20 subjects taken for clinical trial, Incidence of colour of patches shows 7 subjects (35%) were having complete white coloured patches and 09 subjects (45%) were having reddish colour patches and 04 subjects (20%) were having dull white patches. Details of the same is given in the table (Table no. 42) and bar diagram (Graph no.-20)

Table No 42: Showing Incidence of Colour of patches Shwitra Colour of patches Complete white Dull white Reddish No. of Patients 7 4 9 % 35% 20% 45%

Graph no.-20 Showing Incidence of Colour of patches Shwitra

10 8

No. of 6 Patients
4 2 0 Complete white Dull white Reddish

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Observation Distrtibution as per Measurement of patches of 20 cases of Shwitra Out of 20 subjects taken for clinical trial, 13 subjects (65%) were having patches measuring about 0 10 Sq.cm., 02 subjects (10%) were having patches measuring about 11 20 Sq.cm. , 01 subjects (05%) were having patches measuring about 21 30 Sq.cm., 01 subjects (05%) were having patches measuring about 31 40 Sq.cm. and 03 subject (15%) was having patches measuring about 41-50 Sq.cm. Table No 43: Showing Measurement of patches wise distribution of 20 cases of Shwitra

Measurement of patches (Sq.cm.) 0 10 11 20 21 30 31 40 41 50

No. of Subjects 13 02 01 01 03

Percentage 65% 10% 05% 05% 15%

Graph no.-21 Showing Measurement of patches wise distribution of 20 cases of Shwitra

14 12 10

No. of 8 Patients 6
4 2 0 0-10 11 - 20 21 - 30 31 - 40 41 - 50

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Observation Chronicity wise distribution of 20 cases of Shwitra Out of 20 subjects taken for clinical trial, 07 subjects (35%) presented with duration of 1 years, 04 subjects (20%) since 6 months, 03 subjects (15%) since 2 year and 03 subjects (15%) since 4 years. Table No. 44: Showing Chronicity wise distribution of 20 cases of Shwitra Chronicity 6 months 1 year 2 year 3 year 4 year 5 year 6 year No. of Subjects 04 07 03 01 03 01 01 Percentage 20% 35% 15% 05% 15% 05% 05%

Graph no.-22 Showing Chronicity wise distribution of 20 cases of Shwitra

7 6 5

No. of 4 Patients 3
2 1 0 6 months 1 year 2 year 3 year 4 year 5 year 6 year

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Observation Affected side wise distribution of 20 cases of Shwitra Out of 20 subjects taken for clinical trial, 12 subjects (60%) were having affected side in Both hand, 10 subjects (50%) had shown affected side in both leg, 09 subjects (45%) were affected over Fingers and Toes, 07 subjects (35%) were affected over Face. 06 subjects (30%) were affected over neck, 05 subjects (30%) were affected over back. Thorax was affected in 04(20%) Subjects, Abdomen and lip each were affected in 03(15%) Subjects, 01 subject (05%) was affected on eye lid, 02 (10%) subjects were having Patches on Genitalia. Details of the same is given in the table (Table no. 45) and bar diagram (Graph no.-23) Table No. 45: Showing Affected side wise distribution of 20 cases of Shwitra Sl. No. 1 2 3 4 5 6 7 8 9 10 11 Affected side Face Eye lid Lips Neck Hands Legs Fingers And Toes Thorax Abdomen Back Genitalia No. of Subjects 07 01 03 06 12 10 09 04 03 05 02 Percentage 35 % 05% 15% 30% 60% 50% 45% 20% 15% 25% 10 %

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Observation Graph no.-23 Showing Affected side wise distribution of 20 cases of Shwitra

12 10 8

No. of Patients

6 4 2 0

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Observation Distribution as per VIDA SCORE identified in 20 Patients of Shwitra The exploration of VIDA SCORE in 20 Patients suffering from Shwitra revealed that 45% of Patients exhibited +2 Score. Another 20% Patients categorised under +1 score. Mere 10 % of Patients exhibited score +4 and +3 each. 15% of patients had shown score 0 as disease activity was stable since 1 year .Details of the same is given in the table (Table no. 46) and Bar diagram (Graph no.-24) Table No. 46: Showing VIDA SCORE wise distribution of 20 cases of Shwitra VIDA SCORE +4 (Active: 6 weeks or less) +3(Active:6weeks to 3 months) +2 (Active:3 6 months ) +1 ( Active:6 12 months ) 0 (Stable: 1 year or more ) -1 (Stable with spontaneous repigmentation) Graph no.-24 Showing VIDA SCORE wise distribution of 20 cases of Shwitra No. of Patients 2 2 9 4 3 0 % 10% 10% 45% 20% 15% 0%

10 8

No. of 6 Patients
4 2 0 4 3 2 1 0 -1

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RESULTS
In the present study 20 Patients suffering from Shwitra were treated with Shashilekha vati in a dose of 125 mg tid and Gomutra Ghana vati 1 gm tid a day for 56 days in this open clinical trial, pre test post test design. The c o m b i n e d effect of the treatment following medication was assessed periodically in regards to Subjective criteria and objective criteria. Details of the same with statistical analysis adapting paired t test is elaborated in this section on results.

A) Effect on Subjective criteria :


I. Effect on Twaka Shwethata The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be effective in reducing the Twaka Shwethata. Among 20 patients ,The mean score for Twaka Shwethata prior to the treatment was 2.300 which reduced to 0.6500 after the treatment with mean difference of 1.650. The analysis by applying the paired t test proved the statistical extremely significance of the improvement, The change that occurred with the treatment is greater than would be expected by chance (P = <0.001).Details are shown at full length in the table (Table no.47) and Graph (Graph no-25). Table no.-47 Effect on Twaka Shwethata Mean Twaka Shwethata BT AT (SE) (SE) 2.300 0.6500 (0.2065) (0.1500) Difference in Means % S.D. 1.650 71.74% 0.8127 Paired t Test S.E.M 0.182 t =9.079 P P=<0.0001

Graph no.-25 Effect on Twaka Shwethata


3 2.5 2 1.5 1 0.5 0 TwakaShwethata
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II.

Effect on Arun Varnata The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be effective in reducing the Aruna Varnata. Among 20 patients ,The mean score for Arun Varnata prior to the treatment was 0.200 which was reduced to 0.0500 after the treatment with mean difference of 0.150. The analysis by applying the paired t test proved the statistical not quite significance of the improvement, The change that occurred with the treatment is not great enough to exclude the possibility that the difference is due to chance (P = 0.186) .Details are shown at full length in the table (Table no.48) and Graph (Graph no-26). Table no.-48 Effect on Arun Varnata

Mean Arun varnata BT (SE) 0.200 (0.156) AT (SE) 0.0500 (0.0500)

Difference in Means

Paired t Test

S.D.

S.E.M

0.150

75 %

0.489

0.109

=1.371

P=0.186

Graph no.-26 Effect on Aruna Varnata.

0.8 0.6 0.4 0.2 0 ArunaVarnata 0.2 0.4 BT AT56

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III.

Effect on Tamra Varnata The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be effective in reducing the Tamra Varnata. Among 20 patients ,The mean score for Tamra Varnata prior to the treatment was 0.8500 which reduced to 0.2500 after the treatment with mean difference of 0.6000. The analysis by applying the paired t test proved the statistical extremely significance of the improvement, The change that occurred with the treatment is greater than would be expected by chance as P=<0.0021.Details are shown at full length in the table (Table no.49) and Graph (Graph no-27).

Table no.-49 Effect on Tamra Varnata

Mean Tamra varnata


BT (SE) 0.8500 (0.2325) AT (SE) 0.25000 (0.1230)

Difference in Means

Paired t Test

S.D.

S.E.M

0.6000

70.58%

0.7539

0.169

=3.559

P=<0.0021

Graph no.-27 Effect on Tamra Varnata

1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 0.2 TamraVarnata BT AT56


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IV.

Effect on Twak Rukshta The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be very effective in reducing the Twak Rukshta. Among 20 patients ,The mean score for Twaka Rukshta prior to the treatment was 1.300 which reduced to 0.2000 after the treatment with mean difference of 1.100 . The analysis by applying the paired t test proved the statistical extremely significance of the improvement as P=<0.0001.Details are shown at full length in the table (Table no.50) and Graph (Graph no-28).

Table no.-50 Effect on Twak Rukshta

Mean Twaka Rukshta


BT (SE) 1.300 (0.2417) AT (SE) 0.2000 (0.09177)

Difference in Means

Paired t Test

S.D.

S.E.M

1.100

84.62%

0.9119

0.204

=5.395

P=<0.0001

Graph no.-28 Effect on Twak Rukshta

2 1.5 1 0.5 0 TwakaRukshta 0.5 BT AT56


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V.

Effect on Daha The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be little benefit in reducing the Daha. Among 20 patients ,The mean score for Daha prior to the treatment was 0.3000 which reduced to 0.05000 after the treatment with mean difference of 0.2500 . The analysis by applying the paired t test proved the statistical not quite significance of the improvement ,The change that occurred with the treatment is not great enough to exclude the possibility that the difference is due to chance (P = 0.096).Details are shown at full length in the table (Table no.51) and Graph (Graph no-29).

Table no.-51 Effect on Daha

Mean Daha
BT (SE) 0.3000 (0.1638) AT (SE) 0.05000 (0.05000)

Difference in Means

Paired t Test

S.D.

S.E.M

0.2500

83.33%

0.6387

0.143

=1.751

P=0.0961

Graph no.-29 Effect on Daha

1 0.8 0.6 0.4 0.2 0 0.2 0.4 Daha BT AT56


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VI.

Effect on Roma Vivarnata The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be little benefit in reducing the Roma Vivarnata. Among 20 patients ,The mean score for Roma vivarnata prior to the treatment was 0.4000 which reduced to 0.3000 after the treatment with mean difference of 0.1000 . The analysis by applying the paired t test proved the statistical not significance of the improvement , The change that occurred with the treatment is not great enough to exclude the possibility that the difference is due to chance (P = 0.163).Details are shown at full length in the table (Table no.52) and Graph (Graph no-30). Table no.-52 Effect on Roma Vivarnata

Mean Roma vivarnata BT (SE) 0.4000 AT (SE) 0.3000

Difference in Means

Paired t Test

S.D.

S.E.M

0.1000

25%

0.3078 0.0688 =1.453 P=0.1625

(0.1974) (0.1638)

Graph no.-30 Effect on Roma Vivarnata

1 0.8 0.6 0.4 0.2 0 RomaVivarnata 0.2 BT AT56


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VII.

Effect on Kandu

The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be effective in reducing the Kandu. Among 20 patients ,The mean score for Kandu prior to the treatment was 0.300 which reduced to 0.150 after the treatment with mean difference of 0.150 . The analysis by applying the paired t test proved the statistical not significance of the improvement, The change that occurred with the treatment is not great enough to exclude the possibility that the difference is due to chance (P = 0.186) .Details are shown at full length in the table (Table no.53) and Graph (Graph no-31). Table no.-53 Effect on Kandu

Mean Kandu BT (SE) 0.300 (0.179) AT (SE) 0.150 (0.109)

Difference in Means

Paired t Test

S.D.

S.E.M

0.150

50%

0.489

0.109

=1.371

P=0.186

Graph no.-31 Effect on Kandu

1 0.8 0.6 0.4 0.2 0 0.2 0.4 Kandu BT AT56


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B) EffectonObjectivecriteria:
I. Effect on percentage of body involvement The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be effective in reducing the percentage of body involvement. Among 20 patients, The mean score for percentage of body involvement prior to the treatment was 2.250 which reduced to 1.250 after the treatment with mean difference of 1.000 . The analysis by applying the paired t test showed that the change that occurred with the treatment is greater than would be expected by chance; there is a statistically significant change (P = <0.001).Details are shown at full length in the table (Table no.54) and Graph (Graph no-32).

Table no.-54 Effect on percentage of body involvement

Mean % of body involvement BT (SE) 2.250 (0.228) AT (SE) 1.250 (0.280)

Difference in Means

Paired t Test

S.D.

S.E.M

1.000

44.44%

0.725

0.162

=6.164

P=<0.001

Graph no.-32 Effect on percentage of body involvement

3 2.5 2 1.5 1 0.5 0 %ofbodyareainvolved


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II. Effect on Number of shwitra patches The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be effective in reducing the Number of patches. Among 20 patients ,The mean score for number of patches prior to the treatment was 2.450 which reduced to 1.400 after the treatment with mean difference of 1.050 . The analysis by applying the paired t test showed that the change that occurred with the treatment is greater than would be expected by chance; there is a statistically significant change (P = <0.001).Details are shown at full length in the table (Table no.55) and Graph (Graph no-33).

Table no.-55 Effect on Number of patches

Mean Number of patches BT (SE) 2.450 (0.256) AT (SE) 1.400 (0.343)

Difference in Means

Paired t Test

S.D.

S.E.M

1.050

42.85%

0.759

0.170

=6.185

P=<0.001

Graph no.-33 Effect on Number of patches


3.5 3 2.5 2 1.5 1 0.5 0 Numberofpatches BT AT56


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III. Effect on colour of shwitra patches The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be very effective in normalizing the colour of patches. Among 20 patients ,The mean score for colour of patches prior to the treatment was 3.200 which reduced to 0.850 after the treatment with mean difference of 2.350 . The analysis by applying the paired t test showed that the change that occurred with the treatment is greater than would be expected by chance; there is a statistically significant change (P =

<0.001).Details are shown at full length in the table (Table no.56) and Graph (Graph no-34). Table no.-56 Effect on colour of patches

Mean colour of patches BT (SE) 3.200 (0.186) AT (SE) 0.850 (0.221)

Difference in Means

Paired t Test

S.D.

S.E.M

2.350

73.43%

0.933

0.209

=11.261 P=<0.001

Graph no.-34 Effect on colour of patches

4 3.5 3 2.5 2 1.5 1 0.5 0 Colourofpatches BT AT56

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IV. Effect on Size of shwitra patches The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be very effective in reducing the Size of patches. Among 20 patients, the mean score for size of patches prior to the treatment was 3.300 which reduced to 1.600 after the treatment with mean difference of 1.700 . The analysis by applying the paired t test showed that the change that occurred with the treatment is greater than would be expected by chance; there is a statistically significant change (P = <0.001).Details are shown at full length in the table (Table no.57) and Graph (Graph no-35).

Table no.-57 Effect on size of patches

Mean size of patches BT (SE) 3.300 (0.164) AT (SE) 1.600 (0.373)

Difference in Means

Paired t Test

S.D.

S.E.M

1.700

73.43%

1.261

0.282

=6.030

P=<0.001

Graph no.-35 Effect on size of patches

4.5 4 3.5 3 2.5 2 1.5 1 0.5 0 Sizeofthepatches

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V. Effect on Black spots over shwitra patches The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be very effective on black spots occurrence over shwitra patches. Among 20 patients, The mean score for Black spots over patches prior to the treatment was 1.950 which reduced to 0.300 after the treatment with mean difference of 1.650 . The analysis by applying the paired t test showed that the change that occurred with the treatment is greater than would be expected by chance; there is a statistically significant change (P = <0.001).Details are shown at full length in the table (Table no.58) and Graph (Graph no-36).

Table no.-58 Effect on Black spots over shwitra patches

Mean Black spots over patches BT (SE) 1.950 AT (SE) 0.300

Difference in Means

Paired t Test

S.D.

S.E.M

1.650

84.61%

0.489

0.109

=6.030 P=<0.001

(0.0500) (0.105)

Graph no.-36 Effect on Black spots over shwitra patches


3 2.5 2 1.5 1 0.5 0 0.5 Blackspotsovershwitrapatches BT AT56

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Discussion

DISCUSSION The aim of discussion should not be victory, but the progressive acumen. It is accentuated in Sheemad Bhagavat Geeta that Any Discussion will be dwindled down with creation of knowledge; where creation is the only Projection of Light over the form of that which already exists. In this part, discussion on literary review, materials and methods, observation and results is depicted.

Literary review: Skin not only covers and protects the body, but also performs some functions of excretion and metabolism. It also maintains body temperature, its colour and complexion etc. Skin complaints affect all ages from neonate to the elderly and causes harm in a number of ways. Twacha is formed by the Paka of Rakta Dhatu by its Dhatvagni. It consists of seven layers, out of which, Shwitra occurs in the Tamra layer, which is the fourth layer of the Twak. These days skin diseases like Shwitra are increasing in day today life and generating socio cosmetic problem for so many people. Due to chronic nature of this diseases and unsatisfactory treatment the people are so much disheartened and apathic about this disease. That is very difficult to convince them for treatment. This lack of confidence is a great hindrance for continuation of treatment up to the required time. Shwitra is increasing and creating a social problem for many patients. Acharya Charaka, Sushruta and Vagbhata have considered Shwitra as an important disease. The disease Shwitra is pitta pradhana tridoshaja vyadhi. According to acharya Sushruta, Shwitra occurs in tamra the fourth layer of the twak and is 1/8th of Vreehi in its thickness. As per the symptomatology and pathogenesis Shwitra can be correlated to Vitiligo in modern science because of the presenting symptoms like Shweta varna, Tamra varna, Aparisraavi i.e. Non-exudative or Non-oozing type of lesion is another important feature of Shwitra roga. Nidana is one of the main aspects, mainly Ahara Hetu, Vihara Hetu, Achara Hetu, Anya Hetu and Mithyahara Vihara which are known to be responsible in the manifestation of disease Shwitra particularly. While narrating the Nidana for Shwitra the due importance has been given to factors like paapa karma, kritaghnabhava, guru gharshana and poorvakrita karma.

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Acharya have emphasized that the dual part played by Nidana simultaneously, vitiating Tridosha and various Dhatu such as Twak, Rakta, and Mamsa. When Dosha are vitiated will gets lodged in shithila, Twagadi sthana and causes srotosanga to Raktavaha, Mamsavaha, and Medovaha srotas. This leads to vitiation of local pitta i.e. Bhrajaka pitta and causes Shwitra. Though all three dosha are involved mainly, Udana vayu and Bhrajaka Pitta are specially vitiated. These two are held responsible in maintenance of Twak Varna. Vitiligo is a common autoimmune disorder of depigmentation due to loss of melanocyte. Sufferers often have relatives with other organ specific autoimmune disorders. Lesions are often symmetrical and frequently involve the face, hands and genitalia. The hair can also get depigmented. It affects 1% of the population worldwide. Management of Vitiligo involves Phototherapy with PUVA or more recently LT01 has been used. Topical PUVA involves Ultraviolet A radiation thirty minutes after application of topical Methoxasalen to the localized vitiligenous area. Systemic PUVA involve ingestion of Methoxasalen (0.6mg/kg) two hours before irradiation. Finally, transplantation, using a range of techniques including split-skin grafts and blister roof grafts, is used on to derma braded recipient skin. So many remedies are mentioned for the management of Shwitra (Vitiligo) like Shodhana, Shamana, Vyadhihara Rasayana and Bahirparimarjana Chikitsa are the crux of principles of treatment for Shwitra . Repeated administration of Shodhana has been given importance in literatures, whereas Shamana therapy also provides better results. Lepa or external application of medicinal drugs is the choice of treatment in various skin disorders, swellings, painful conditions, wounds and pruritis. It also has a cosmetic value as it has the benefit of repigmentation and avoiding scar formation in the wounds. The recurrence of Shwitra is remote possible if all modalities of management like Shodhana, Shamana, Vyadhihara Rasayana and Bahirparimarjana are followed as treatment. Oral medication Shashilekha vati and Gomutra Ghana vati with bakuchi taila and its therapeutic efficacy is the subject matter of this dissertation work.

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Discussion

Materials and Methods : 1. Medicinal formulation for oral medication : In the present clinical study; each patient was given with Shashilekha vati 125mg tid with 10ml of Bakuchi Taila as anupana (a.c.) and Gomutra Ghana Vati 1 gm tid (a.c.) for 56 days. a) Shashilekha vati : Shashilekha vati is a Herbomineral preparation; elitly indicated in Shwitra as well as Kushtha. Here, Shuddha Parada and Shuddha Gandhak should be mixed in equal quantity followed by adding equal quantity of Tamra Bhashma. Bhavana with Shodhita Bakuchi seed Kwatha should be given to it. Fine powder of the mixture should be obtained, dried and later vati is prepaired, which is used for oral administration along with Bakuchi Taila as anupana. b) Gomutra Ghana Vati : Gomutra is claimed to be an omniscient effective medication in the cure of the shwitra particularly Gomutrasava .Palatability was the main drawback against acceptance of Gomutrasava so in the present study with the unique concept of Ghanakriya it was converted into Gomutra Ghana vati to rescue the issues related to adaptation of Gomutrasava. Chitrak, Shunthi, Marich, Pippali, Gomutra are used to make kwatha.The mixture is kept on slow fire for Ghana kriya and should be heated till it get convert into solid and later Ghana vati is prepared for oral administration.

2. Methodology: This is an open explanatory clinical study with a pre-test and post-test design. 20 Patients between the age group of 16 to 70 years suffering from Shwitra were taken for the study from O.P.D and I.P.D of SDM college of Ayurveda Hospital, Udupi. The Pratyatma lakshana of Shwitra like Twaka Shwetata, Aruna Varnata, Tamra varnata, Rukshta, Daha, Roma vivarnata, and Kandu were mainly considered for the diagnosis as per Ayurvedic science. As a routine, hematological investigations were carried out in all the Patients taken for the study. Once they were diagnosed as Shwitra they should fulfill the inclusion and exclusion criteria. Even though Shodhana is best for Shwitra but that is not indicated in every person, so in the present study, Shashilekha vati and Gomutra Ghana vati as Shamana oushadha is used. In the present study, 20 Patients were registered which were subjected to oral administration of the Shashilekha vati 125 mg tid (a.c.) along with Bakuchi Taila 10 ml as anupana
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Discussion

and Gomutra Ghana vati in dose of 1gm tid (a.c.) for the 56 days. During this interval monthly assessment is done by using Symptom scoring for subjective criteria such as Twaka shwetata, Aruna varnata, Tamra varnata, Daha, Kandu, Rukshta, Roma Vivarnata. Objective criteria are assessed such as percentage of body area involved, Size, colour, number and presence of black spots over depigmented patches through special adopted scoring method.

Observation: Following observations were made during the clinical trial of Shwitra. These observations are mainly based upon Age, Sex, Occupation and Religion etc. Age: In the present study, it was observed that, majority of subjects (25%) were between the age group of 31 to 40 years. This shows the prevalence of illness is in Madhyamavastha. In this age possibility of mental stress and other exposure i.e. occupational, environmental, unwholesome food were more which leads to Shwitra. It affects all the persons irrespective of age, but in general it is more common in the age group between 20- 40 years. Some observation by clinicians also recorded many cases of vitiligo at the age of 5 years to 15 years and at menopause. Sex: In the present study 14 subjects (70%) were males and 6 subjects (30%) were females. So it can be said that in this study males are more affected than females. Religion, Habitat and Marital status: These do not play any major role in the causation of the disease. Though in the present study the percentage of Hindus, Urban people and married subjects were more, but Religion and Habitat reflect the demographic distribution. Occupation: In the present study it was observed that 6 Housewives (30%), 6 employee (30%) had more incidence of Shwitra. These groups of people are more cosmetic conscious and the study observed that they had lesions predominantly on the face and exposed parts of the upper and lower limbs, which made them more conscious and socially stressful.

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Discussion

Education: Out of 20 subjects were taken for clinical trial 15 subjects (75%) were graduates, 4 subjects (25%) were studied till High School, and 01 subject (5%) was studied till Primary. This does not have any relation with the disease manifestation. Socio-Economic Status: In this series, Majority of Patients belonged to the Middle class (70%), 20% were in upper middle class. This trend of distribution in this sample also represents the socioeconomic state of individuals in and around Udupi. Diet: Equal of the subjects (50%) were taking mixed diet, where they were consuming fish, meat and chicken along with spicy and oily supplements. Such diets are directly responsible for the pradushana of pitta dosha and rakta dhatu which ultimately play important role in the samprapti of Shwitra. Rest 50% patients were vegetarian. Habit: Out of 20 subjects taken for clinical trial 09 subjects (45%) were having the habit of taking Alcohol, 03 subjects (15%) were smoker. Any role of addictions either in the causation or in perpetuation of Shwitra could not be said from this sample of 20 Patients. Prakruti: Out of 20 subjects were taken for clinical trial 7 subjects (35%) were vata kapha prakruti, 08 subjects (40%) were pitta kapha prakruti . 04 subjects (20%) were vata Pitta prakruti. Shwitra is a disorder predominant of pitta with involvement of kapha Dosha. It may be contended that person belonging to Pitta-kapha Prukruti are more prone to get Shwitra. The same is reflected in the present sample. Satva: Out of 20 subjects taken for clinical trial, 10 subjects (50%) were belonging to Madhyama Satva, 08 subjects (40%) had Avara Satva. Madhyama and Avara Satva people are more prone to intake of Viruddha Ahara which may cause Shwitra. Abhyavarana jarana shakti : Patients having Madhyama and Avara Abhyavaharana Jarana Shakti tend to develop agnimandya and consequently ama. In the present study a total of 90 % of subject had either Avara or Madhyama Abhyavaharana and Jarana Shakti. This observation agrees with the understanding of risk of diseases due to Agnimandya.
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Discussion

Treatment History: Out of 20 subjects taken for clinical trial, 13 subjects (65%) had received treatment among them 45% had taken allopathic treatment where as rest 20 % had taken shodhana treatment in past. As Shwitra causes cosmetic problem as well as social stigma, people do try to get rid of it by all the possible ways and means. Manasika Bhava: Out of 20 subjects taken for clinical trial, 9 subjects (45%) were having Chinta, 06 subjects (30%) were having Bhaya, 08 subjects (40%) were having Shoka and 03 subjects (15%) were having Krodha. As Shwitra is a cosmetological problem many subjects were having more thinking and worried. Number of patches: Out of 20 subjects taken for clinical trial, Incidence shows that 10 subjects (50%) were having about 5 patches; remaining 6 subjects (30%) were having about 10 patches. Usually the number of patches increases when the subjects do not seek proper treatment and due to chronicity. Colour of patches: Out of 20 subjects taken for clinical trial, Incidence of colour of patches shows 04 subjects (20%) were having dull white coloured patches and 7 subjects (35%) were having complete white colour patches and 09 subjects (45%) were having reddish patches. During the chronic nature the skin turns from normal to reddish, dull white and full white colour due to lack of melanin pigment. Measurement of patches: Out of 20 subjects taken for clinical trial, 13 subjects (65%) were having patches measuring about 0 10 Sq.cm., 02 subjects (10%) were having patches measuring about 11 20 Sq.cm.,01 subjects (5%) were having patches measuring about 21 30 Sq.cm., 01 subjects (5%) were having patches measuring about 31 40 Sq.cm., and 03 subject (15%) was having patches measuring about above 50 Sq.cm. Usually the size of patches increases when the subjects does not seek proper treatment and due to chronicity. Chronicity: Out of 20 subjects taken for clinical trial, 05 subjects (25%) was having chronicity of 6 years, 01 subject (5%) presented with duration of 3 years, 03 subjects (15%) from 2 years, 07 subjects (35%) 1 year and 04 subjects (20%) from 6 months. This shows the chronic nature of the disease.
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Discussion

Affected site: Out of 20 subjects taken for clinical trial, 12 subjects (60%) were having affected side in Both hand, 10 subjects (50%) had shown affected side in both leg, 09 subjects (45%) were affected over Fingers and Toes, 07 subjects (35%) were affected over Face. 06 subjects (30%) were affected over neck, 05 subjects (30%) were affected over back. Thorax was affected in 04(20%) Subjects, Abdomen and lip each were affected in 03(15%) Subjects, 01 subject (05%) was affected on eye lid, 02 (10%) subjects were having Patches on Genitalia. Usually the patch occurs over the periphery aspect of the body, mainly on hands, legs and face which are exposed more outside. Vida score : The exploration of VIDA SCORE in 20 Patients suffering from Shwitra revealed that 45% of Patients exhibited +2 Score. Another 20% Patients categorised under +1 score. Mere 10 % of Patients exhibited score +4 and +3 each. 15% of patients had shown score 0 as disease activity was stable since 1 year. Ongoing it is clear that more Subject were identified as +2 score means disease is active since 3-6 months; which reveals more subjects are cognizant and mindful about ailment in early stage itself.

Effect of therapy : This open clinical trial is designed to carry out a comprehensive literary study on Shwitra and also to evaluate the combined effect of oral medication with Shashilekha vati and Gomutra Ghana Vati in shwitra. Significant remission in the cardinal symptoms was observed that included Twaka shwetata, Tamra varna, Aruna varnata, Roma vivarnata, Daha, Rukshata, Kandu. Improvement in objective criteria was also recorded such as Number of patches, Colour of patches, and Size of patches .The results thus obtained are statistically significant. During the course of the study, Redness of the patches was observed that after giving treatment for 28days (1st visit), they were observed without any sphota. In few patients visphota or blister developed particularly who had underwent shodhana in past. After rupturing, there was improvement. Some patients developed local or generalized itching and it was observed that these patients had a faster rate of improvement. During pigmentation process, two types of improvement was seen. In 1st type repigmentation started at the margins of the patches which showed delayed reduction
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Discussion

of size, and in 2 type repigmentation started in the middle of the patches in form of black spots and those repigmented patches joined together resulting in configured the normal skin colour by aggregation. The pigmentation process was faster in case of small patches.

nd

Effect of therapy on Individual Signs and Symptoms : Twaka Shwetata : Shweta coloration or De- pigmentation of the lesion is due to the morbid kapha Dosha in Patients suffering from Shwitra. Twaka Swetata is rectified by 71.74 % in Patients of Shwitra treated with Shashilekha vati and Gomutra Ghana vati. This clearly

indicates the appreciable therapeutic improvement in regards to Twaka Swetata in Patients of Shwitra. Bakuchi and Tamra are known for its effect in rectifying the Swetata of the skin. This is proved by this clinical study as the Patients had satisfactory correction of the symptom Twaka Shwetata.

Aruna Varnata: Aruna and Shyava coloration of the lesion accounts for the vitiation of Vata Dosha in the skin. Aruna varnata is decreased by 75 % in Patients of Shwitra treated with same medicine. This change is considered due to reduced aruna varnata and more pigmentation after healing of ruptured blister which was seen in few subjects.Both medicines contains drugs which have Tikshana Guna, Ushana Virya and Ksharana property. Due to Teekshna & Ushna guna, it has many functions such as Dahana, Pachana, Vidarana and Vilayana, and also does Shodhana. Thus it leads to Visphota (bleb) formation due to Pitta Prakopa, which clearly indicates the appreciable therapeutic improvement in regards to Vaivarnya in Patients of Shwitra even though it is hyperpigmentation.

Tamra varnata: Reddish coloration is due to the morbidity of Pitta Dosha. This was rectified by 70.58 % in the patient of shwitra treated with same combined medicine. Bakuchi is being one among the active ingredient it reconcile by its Katu, tikta rasa, Laghu rooksha guna and ushna veerya and acts as Sroto shodhaka, kapha vata shamaka and it is mainly pitta vardhaka. It stimulates the Bhrajaka pitta to perform its function and helps in the production of colour. By its Sroto shodhaka action it eliminates the sanga
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at the level of Rakta dhatwagni and acts on Bhrajaka pitta. By its Prabhava it is Shwitra, kushtaghna and Krimighna i.e. is responsible for relieving the Tamra varnata of the skin

Twaka Rukshata : Vata Dosha is invariably involved in all the Kshudra kushta as well as Shwitra. The morbid Vata Dosha affects the Rasa Dhatu in the Tvak leads to Rukshata in the lesions of Shwitra. Alleviation of Vata Dosha and normalising the Rasa Dhatu helps in relieving the symptom of Rukshata. In the present study the Rukshata is amended by about 84.62 % proves the effect of Shashilekha vati along with Bakuchi Taila as anupana and Gomutra Ghana vati in this regard in patients suffering from the Shwitra.

Daha: In the Patients of Shwitra the morbidity of Pitta Dosha involving the Rakta Dhatu is responsible for the occurrence of Daha. Reduction in the symptom Daha by 83.33% proves the therapeutic efficacy of Shashilekha vati along with Bakuchi Taila as anupana and Gomutra Ghana vati in Patients suffering from Shwitra.

Roma Vivarnata: Roma vivarnata over lesion is due to the morbid Vata , Pitta and Kapha dosha in Patients suffering from Shwitra. In contrast to this, reddish coloration is due to the morbidity of Pitta Dosha. Whitish accounts for the vitiation of Kapha Dosha at the root of Roma. Roma Vivarnata is rectified by 25 % in Patients of Shwitra treated with Shashilekha vati along with Bakuchi Taila as anupana and Gomutra Ghana vati. This clearly indicates the appreciable therapeutic improvement in regards to Roma Vaivarnya in Patients of Shwitra. Bakuchi, Pippali and Gandhaka are known for its effect in rectifying the Vaivarnya of the Roma as well as skin. This is proved by this clinical study as the Patients had satisfactory correction of the symptom Roma Vaivarnya.

Kandu: Morbid Kapha Dosha as well as Vata Dosha is responsible for the Kandu in lesions of Shwitra. Hence the regimens that alleviate these two Dosha are likely to be effective

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in relieving the symptom Kandu. Further the abnormality of Rakta Dhatu contributes in the establishment of the Kandu in Shwitra. Complimentary to say, the medicaments that rectify the abnormality of Rakta Dhatu tend to aid in remission of the symptom Kandu. Shashilekha vati along with Bakuchi Taila as anupana and Gomutra Ghana vati is said to be effective in alleviation of Kapha Vata Dosha and rectifier of Rakta Dhatu as well. The reduction in the severity of Kandu by 50% proves its efficacy in normalization of Vata Kapha Dosha and Rakta Dhatu. Added to this the Bakuchi and Gandhaka, the major ingredient of Shashilekha vati has known Kandhughna effect.

Effect on percentage of body involvement: The Combined effect of Shashilekha vati and Gomutra Ghana vati was found to be effective in reducing the percentage of body involvement. The mean number of patches before treatment was 2.250, which reduced to 1.250 after treatment. The therapy provided 44.44% relief. The effect of the therapy was statistically highly significant at the level of P<0.001. Both medicine provides good improvement in Shwitra as mainly Bakuchi present in the drug is having Ushna Veerya , Kushtaghna and Shwitraghna properties.

Number of Patches: The mean number of patches before treatment was 2.450 which reduced to 1.400 after treatment. The therapy provided 42.85% rectification. The effect of the therapy was statistically highly significant at the level of P<0.001. During pigmentation process, two types of improvement, was seen. In 1st type repigmentation started at the margins of the patches and in 2nd type repigmentation stared in the middle of the patches and those regimented patches joined together resulting normal skin colour. Both medicines provide good improvement in regards to number of patches.

Colour of the patches: The Mean Parameter Colour of patches before treatment was 3.200 which reduced to 0.850 after treatment. The therapy provided 73.43% reform on this parameter. The effect of therapy was statistically highly significant at the level of P<0.001. The above said highly significant values are ultimately suggestive of marked response (repigmentation) shown by these subjects towards the comprehensive management
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Discussion

which meliorate Bhrajaka Pitta so that alteration in the colour of Shvitra (Vitilgo) patches was rectified impressively. Therefore for getting good results and complete remission the intervention of study drug should be sustained.

Size of the Patches: The mean size of patches before treatment was 3.300 which reduced to 1.600 after treatment. The therapy provided 73.43% relief. The effect of the therapy was statistically highly significant at the level of P<0.001. The comprehensive management has given good result in deducting size of the patches.

Number of black spots appearing in the observed Shvitra (vitiligo) patches: Effect of study drug given proved to be highly significant with respect to increase in number of black spots in observed Shvitra (Vitiligo) patch with an improvement of 84.61% (p>0.001). In the present study after the intervention of both combined medicine on number of black spots appearing in the observed Shvitra (Vitiligo) patches was markedly improved. As Bakuchi has Katu, tikta rasa, Laghu rooksha guna and ushna veerya acts as Sroto shodhaka, kapha vata shamaka and it is mainly pitta vardhaka. Hence there may be increase in the activity of Bhrajaka Pitta leading to formation of melanin pigments in Tvaka (skin) resulting in appearance of black spots. Tamrabhasma, chitraka and bakuchi is said to have potent therapeutic effect in curing shwitra. The present study showing significant reduction in the vida score following medication corroborates the same. Tamra, the fourth layer of the Twak, wherein a copper containing enzyme known as Tyrocinase which is solely responsible for the synthesis of melanin pigments by the melanocytes in the presence of sun light. Copper and furocoumarins such as Psoralens which are essential ingredient present in Bakuchi seed, acts on photo active stimulation of melanocytes, and induce their proliferation. The treatment used in the study showed statistically significant coloration of the skin in about 56 days can be thus explained by the chemical composition of the ingredients of the medicine. In a nut shell, 20 Patients of either sex suffering from Shwitra between the age group of 16 to 70 were subjected to open explanatory clinical study of pre test and post test design, treated with oral medication of Shashilekha vati in a dose of 125 mg
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thrice a day along with Bakuchi Taila 10 ml as Anupana before food and Gomutra Ghana vati in a dose of 1 gm thrice a day before food for 56 days. The study showed significant improvement in almost all the outcome measures of Shwitra that included Subjective criteria such as Twaka Swetata, Aruna Varnata, Tamra Varnata, Rukshta, Kandu, Daha and objective criteria such as percentage of Body area involved , number, colour, size and black spot appearance on patches of Shwitra. This implies that the Shashilekha Vati and Gomutra Ghana vati is effective in the correction of all the morbidities of Vata, Pitta, Kapha, Rasa, Rakta, Mamsa and meda that are invariably involved in Shwitra. Though this is the fact, it is also true that the improvement observed is not complete. As the Shwitra is caused due to Bahu Doshavastha, Shodhana is indispensable to cure the illness. In the present study only the Shamana medication with Shashilekha Vati and Gomutra Ghana vati is tried giving gratified improvement. Gratuitously to say the Shamana medication with Shashilekha vati and Gomutra Ghana vati with prior Shodhana treatment may ensure complete remission of the illness Shwitra. On the other hand, Shwitra is a chronic lingering disease, the Shashilekha vati and Gomutra Ghana vati is tried only for 56 days showed marked response. Therefore it may be suggested to sustain the duration of treatment until complete overthrown of the illness. From this discussion it can be confidently said that, Shashilekha Vati and Gomutra Ghana vati is very effective in the treatment of Shwitra Roga, and for better results the pre-treatment with Shodhana and longer duration of Shamana with combination of Shashilekha vati and Gomutra Ghana vati secures best results. No doubt the study proves the efficacy of repigmentation of the skin in patients suffering from shvitra / vitiligo although complete remission was recorded in only few patients. This implies the medicine need to be continued more than the duration tried in the study until the complete remission, thus this paves way for more studies on this regimen with prolonged duration of the treatment is safe. The therapeutic effect may be exemplied further by the prior planning of shodhana treatment.

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Conclusion

CONCLUSION
20 patients of either sex suffering from Shwitra between the age group of 16 to 70 years who attended the SDM Ayurveda Hospital were subjected to open explanatory clinical trial of pre test and post test design. The patients were treated with combined oral medication of Shashilekha vati in a dose of 125 mg thrice a day along with Bakuchi Taila 10 ml as Anupana before food and Gomutra Ghana vati in a dose of 1 gm thrice a day before food for 56 days. After completion of the study the following are the conclusions drawn. Shwitra identical to Kushta in general, is caused due to the morbidity of the three dosha involving Tvak, Rakta, Mamsa and Meda. Shashilekha vati and Gomutra Ghana vati is effective in reducing the severity of symptoms of Shwitra. Marked reduction in the mean score of outcome measures was identified such as Twaka Shwetata, Aruna Varnata, Tamra Varnata, Rukshta, Kandu, Daha, Roma Vivarnata, extent of body region affected, number, size, colour, and appearance of black spot on shwitra patches; all are recorded and are mostly statistically highly significant. Shashi lekha vati and Gomutra Ghana vati effectively said to be reduces the activity of Shwitra. Activity of Shwitra is assessed by VIDA score and is more reliable if done after a period of one year With few incidences of blister formation on application of Bakuchi Taila, the medication is safe with no any untoward symptoms

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Summary

SUMMARY Shwitra is a chronic relapsing skin disorder which is in reality challenge to the whole medical field as the complete cure to this illness is a remote possibility. No doubt the illness is not fatal, but it poses embarrassment and inferiority complex to the person affected. More to add, the person having Shwitra will feel that they are separated from the society and get depressed psychologically and our society also has a contemptuous opinion regarding these persons. Shwitra is also a variety of Kushta, which can spoil the beauty of skin and may pose major or minor cosmetic problems and is

characterized by whitish depigmentation .The lesions of shwitra being dry and also non infectious, thus differs from the kushtha in general. Based on the symptoms Shwitra can be correlated to vitiligo of the modern science. Shodhana and Shamana measures are proved to be efficacious in the treatment of Shwitra. Review of

previous work done reveals that meagre numbers of clinical trials have been carried out establishing the evidence of effect of Shamana therapy in the management of Shwitra. Hence any attempt of clinical work in this regard is justified. With this connotation the present study entitled An open explanatory clinical trial with a pretest and post-test design evaluating combined therapeutic effect of Shashilekha Vati and Gomutra Ghan Vati in Shwitra is planned. Objective: To study nidana panchaka of Shwitra according to Ayurvedic texts in detail. To Rectify and study literature for the different clinical aspects of Shwitra in ayurveda and Vitiligo in Modern medicine for critical analysis in detail. To assess the role of Shashilekha vati along with Gomutra Ghana vati internally in Shwitra. Design of Study: It was an open explanatory clinical study with pre-test and post-test design.

Settings: SDM Hospital of Ayurveda , Udupi, Karnataka

Diagnostic Criteria: Must have Pratyatma Lakshana of Shwitra ie visible depigmented lesion.

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Summary

Inclusion Criteria: Patients fulfilling the criteria of diagnosis irrespective of sex or creed. Patients between the age group of 16 to 70 years.

Exclusion Criteria: Chronicity more than 10 years. Spread more than 50 % of the body involvement. Patient with any other systemic illness like diabetes mellitus, IHD etc.

Outcome Measures: Subjective Criteria: Twaka Shwetata, Tamra Varnata, Aruna varnata, Daha, Rukshta, Kandu, Roma Vivarnata, VIDA score. Objective Criteria: Percentage of body area involved, Number, Size, colour, Number of black spots over Shwitra Patches. Intervention: Following oral medications were given for 56 days Shashilekha vati - 125 mg. tid (a.c.) Along with Anupan- Bakuchi Taila 10 ml + Madhu Gomutra ghan vati 1 gm tid (a.c.)

Observation & Results: 25 % of patients of Shwitra were in the age group 31-40; 70% were males and remaining 30% were females; 30% of patients were either employee or housewives; 85% were Hindu; 75% were graduates; 55% of patients were married; 70% belonged to the middle socio economical class and 75% patients were from urban area. It is observed that 40% of the patients presented with Pittakapha Prakruti; 50% of them had Madhyama Satva; Avara Satmya was identified in 25%; 55% belonged to Madhyama Ahara Shakti and 50% subjects had no addiction. Exploration of nidana in 20 subjects revealed that 80% had erroneous food habits as causative factor. 12 patients presented with Twaka Shwetata as leading presenting symptom. The administration of Shashilekha vati and Gomutra Ghana Vati was found to be effective in reducing the Twaka Shwetata. The mean Twaka Shwetata prior to the treatment was 2.300 which reduced to 0.6500 after the treatment with mean difference
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Summary

of 1.650. The analysis by applying the paired t test proved the statistical significance of the improvement as P=<0.0001. The mean Score for Aruna Varnata stepped down from initial value of 0.200 to 0.0500 after the treatment, with a difference of 0.150. The mean score of Tamra Vaivarnya prior to the treatment was 0.8500. After the treatment the same reduced to 0.2500. An initial mean Twacha Rukshta score was 1.300 in 20 patients suffering from Shwitra. The value dropped to 0.2000 following the treatment thus recording good improvement by the medication. The mean Score for Daha reduced from initial value of 0.3000 to 0.0500 after the treatment, with a difference of 0.2500. The mean score of Roma Vivarnata prior to the treatment was 0.4000. After the treatment the same reduced to 0.3000. An initial mean Kandu score was 0.300 in 20 patients suffering from Shwitra. The value dropped to 0.150 following the treatment thus recording good improvement by the medication The percentage of area involved is reduced to a larger extent by the medication with Shashilekha vati and Gomutra Ghana vati in all the 20 patients. The mean score for same prior to the treatment was 2.250 which reduced to 1.250 with mean difference of 1.000 after treatment. The number of patches reduced markedly following the treatment with same. The mean score number of patches prior to the treatment was 2.450, which reduced to 1.400 with mean difference of 1.050 after treatment. The mean Score for colour reduced from initial value of 3.200 to 0.850 after the treatment, with a difference of 2.350. The mean score of number of black spot over shwitra patches prior to the treatment was 1.950. After the treatment the same reduced to 0.300. The administration of Shashilekha vati and Gomutra Ghana Vati was found to be effective in reducing the size of patches. The mean score prior to the treatment was 3.300 which reduced to 1.600 with mean difference of 1.700 after treatment. All these outcome measures were analysed by paired t test and the improvement found by the medication was statistically highly significant confirming the efficacy of Shashilekha vati and Gomutra Ghana vati in the subsidence of Shwitra.

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Discussion 20 Patients of either sex suffering from Shwitra between the age group of 16 to 70 were subjected to open explanatory clinical study of pre test and post test design, treated with oral medication of Shashilekha vati in a dose of 125 mg thrice a day along with Bakuchi Taila 10 ml as Anupana before food and Gomutra Ghana vati in a dose of 1 gm thrice a day before food for 56 days. The study showed significant improvement in almost all the outcome measures of Shwitra that included Subjective criteria such as Twaka Shwetata, Aruna Varnata, Tamra Varnata, Rukshta, Kandu, Daha and objective criteria such as percentage of Body area involved , number , colour , size and black spot appearance on patches of Shwitra. This implies that the Shashilekha Vati and Gomutra Ghana vati is effective in the correction of all the morbidities of Vata, Pitta, Kapha, Twaka, Rakta, Mamsa and medas that are invariably involved in Shwitra. Though this is the fact, it is also true that the improvement observed is not complete. As the Shwitra is caused due to Bahu Doshavastha, Shodhana is indispensable to cure the illness. In the present study only the Shamana medication with Shashilekha Vati and Gomutra Ghana vati is tried giving gratified improvement. Gratuitously to say the Shamana medication with Shashilekha vati and Gomutra Ghana vati with prior Shodhana treatment may ensure complete remission of the illness Shwitra. On the other hand, Shwitra is a chronic lingering disease, the Shashilekha vati and Gomutra Ghana vati is tried only for 56 days showed marked response. Therefore it may be suggested to sustain the duration of treatment until complete overthrown of the illness. From this discussion it can be confidently said that, Shashilekha Vati and Gomutra Ghana vati is very effective in the treatment of Shwitra Roga, and for better results the pre-treatment with Shodhana and longer duration of Shamana with combination of Shashilekha vati and Gomutra Ghana vati secures best results. Also this study airts for further planning of the clinical study to know the additional effect of Shodhana treatment , which is essential in the treatment of chronic lingering disease like Shwitra.

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Conclusion Management of Shwitra with Shamanoushadhi as Shashilekha Vati and Gomutra Ghana Vati provides very effective in the remission of the illness. The improvement recorded is definite and not by chance as proved by the paired t test. Marked reduction in the mean score of Twaka Shwetata, Aruna Varnata, Tamra Varnata, Rukshta, Kandu, Daha, Roma Vivarnata, extent of body region affected, number, size, colour and appearance of black spot on shwitra patches. The medication is safe with no any untoward symptoms with exception of blister formation in some.

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Bibliographic References

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Sansthan;2007. Pp.738; p.339 8. Agnivesha, Charaka Samhita revised by Charaka &Dridabala,with Ayurveda Dipika comentary by Chakrapanidatta, foreword by Acharya Yadav ji Trikam ji. 5th edition.Varanasi: Choukhamba Sanskrit Sansthan;2001. Pp.738; p.56 9. Sushruta, Sushruta Samhita, with Nibhandha Sangraha comentary by Dalhana, foreword by Acharya Yadav ji Trikam ji. 8th edition.Varanasi: Choukhamba Sanskrit Sansthan;2005. Pp.824; p.339 10. Agnivesha, Charaka Samhita revised by Charaka &Dridabala,with Ayurveda Dipika comentary by Chakrapanidatta, foreword by Acharya
AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 171 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 172 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 173 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 174 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 175 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 178 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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112. Vagbhata, Ashtangahrdayam Sarvanga sundari commentary of Arunadatta and Ayurveda rasayana commentary of Hemadri, Edited by Bhishagacharya Harishastri Paradakara Vaidya, 9th Edition.Varanasi: Choukhambha

Orientalia;2005 , Pp.956, p.712 113. Sushruta, Sushruta Samhita, with Nibhandha Sangraha comentary by Dalhana, foreword by Acharya Yadav ji Trikam ji. 8th edition.Varanasi: Choukhamba Sanskrit Sansthan;2005. Pp.824;p.447 114. Agnivesha, Charaka Samhita revised by Charaka &Dridabala,with Ayurveda Dipika comentary by Chakrapanidatta, foreword by Acharya Yadav ji

Trikam ji. 5th edition.Varanasi: Choukhamba Sanskrit Sansthan;2007. Pp.738 p.458 115. Agnivesha, Charaka Samhita revised by Charaka &Dridabala,with Ayurveda Dipika comentary by Chakrapanidatta, foreword by Acharya Yadav ji

Trikam ji. 5th edition.Varanasi: Choukhamba Sanskrit Sansthan;2007. Pp.738 p.458 116. Agnivesha, Charaka Samhita revised by Charaka &Dridabala,with Ayurveda Dipika comentary by Chakrapanidatta, foreword by Acharya Yadav ji

Trikam ji. 5th edition.Varanasi: Choukhamba Sanskrit Sansthan;2007. Pp.738 p.458 117. Vagbhata, Ashtangahrdayam Sarvanga sundari commentary of Arunadatta and Ayurveda rasayana commentary of Hemadri, Edited by Bhishagacharya Harishastri Paradakara Vaidya, 9th Edition.Varanasi: Choukhambha

Orientalia;2005 , Pp.956, p.246 118. Vagbhata, Ashtangahrdayam Sarvanga sundari commentary of Arunadatta and Ayurveda rasayana commentary of Hemadri, Edited by Bhishagacharya Harishastri Paradakara Vaidya, 9th Edition.Varanasi: Choukhambha

Orientalia;2005 , Pp.956, p.266 119. Sushruta, Sushruta Samhita, with Nibhandha Sangraha comentary by Dalhana, foreword by Acharya Yadav ji Trikam ji. 8th edition.Varanasi: Choukhamba Sanskrit Sansthan;2005. Pp.824;p.615-615 120. Vriddha Vagbhata, Ashtanga sangraha with Shashilekhayakhya commentary by Indu, Edited by Dr.Shivaprasad Sharma, Varanasi, Chaukhambha

Sanskrit series office, 2008; Pp.935 p.777-778

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Bibliographic References

121. Yoga Ratnakara, edited by Dr. Madham Shetty Suresh Babu; Varanasi; Chowkhamba Sanskrit Series Office 2004. p.234 122. Mauro picardo alain taieb ed, chapter 48,3.7.2.,2010,vitiligo,Springer Heidelberg Dordrecht,London Newyork, Pp 410 123. Mauro picardo alain taieb ed, chapter 38,3.2.1.,2010,vitiligo,Springer Heidelberg Dordrecht,London Newyork, Pp 329 124. Mauro picardo alain taieb ed, chapter 47,3.7.1.,2010,vitiligo,Springer Heidelberg Dordrecht,London Newyork, Pp 397 125. Yogratnakara ; Vaidyaprabh Hindi Commentary ; Dr. Tripathi Indradev ; Dr Tripathi Dayashankar ; Varanasi ; Krishnadas Academy ; Ist edition ; 1998 ; P.p 894 ; P.662 126. Sushruta ; Shushruta samhita (vol-2) ; Prof. Srikantha Murthy K.R. ; Varanasi ; Chaukhambha Orientalia ; Second Edition 2005 ; P.p 499 ; P.111. 127. vagbhata ; Astanga hrudayam ; edited with Nirmala Hindi commentary along with special deliberation ; Dr. Tripathi Brahmanand ; Delhi ; Chaukhamba Sanskrit Pratishthan ; Edition 2009 ; P.p 1219 ; P.798 128. Sharma PC, Yelne M.B, Dennis T.J, Database on Medicinal plants used in Ayurveda, Volume 2, CCRAS publication, 2005, Pp590. P.89 129. Sharma Sadananda, Rasa Tarangini, with Rasavijnana Hindi commentary by Kashinatha Shastri, 11th edition. Delhi: Motilal Banarasidas; 1979. Pp772; p71-77. 130. Sharma Sadananda, Rasa Tarangini, with Rasavijnana Hindi commentary by Kashinatha Shastri, 11th edition. Delhi: Motilal Banarasidas; 1979. Pp772; p174-182. 131. Sri Vagbhathacharya, Rasaratnasamucchaya with The Suratnojjvala hindi commentary Edited by, Kaviraj Sri Ambikadatta Shastri, Varanasi,

Choukhambha Amarabharati Prakashan,2001; Pp-647,P.100 132. Sharangadhara, Sharangadhara Samhita, with Adhamllas deepika and Kashiramas Gudartha Deepika Commentary, edited by PandithParashuram Shastry, Bombay, Nirnaya Sagara Press, 1931,2nd ed, Pp 398; P.144 133. Sharma PC, Yelne M.B, Dennis T.J, Database on Medicinal plants used in Ayurveda, Volume 1, CCRAS publication, 2000, Pp528, p.102 134. Sharma PC, Yelne M.B, Dennis T.J, Database on Medicinal plants used in Ayurveda, Volume 5, CCRAS publication, 2002, Pp572, p.315
AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE 183 COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Bibliographic References

135. Sharma PC, Yelne M.B, Dennis T.J, Database on Medicinal plants used in Ayurveda, Volume 5, CCRAS publication, 2002, Pp572, p.187 136. Sharma PC, Yelne M.B, Dennis T.J, Database on Medicinal plants used in Ayurveda, Volume 3, CCRAS publication, 2005, Pp635, p.472 137. Agnivesha, Charaka Samhita revised by Charaka &Dridabala,with Ayurveda Dipika comentary by Chakrapanidatta, foreword by Acharya Yadav ji

Trikam ji. 5th edition.Varanasi: Choukhamba Sanskrit Sansthan;2007. Pp.738 p.284 138. Sushruta, Sushruta Samhita, with Nibhandha Sangraha comentary by Dalhana, foreword by Acharya Yadav ji Trikam ji. 8th edition.Varanasi: Choukhamba Sanskrit Sansthan;2005. Pp.824;p.143 139. Agnivesha, Charaka Samhita revised by Charaka &Dridabala,with Ayurveda Dipika comentary by Chakrapanidatta, foreword by Acharya Yadav ji

Trikam ji. 5th edition.Varanasi: Choukhamba Sanskrit Sansthan;2007. Pp.738, p21 140. Agnivesha, Charaka Samhita revised by Charaka &Dridabala,with Ayurveda Dipika comentary by Chakrapanidatta, foreword by Acharya Yadav ji

Trikam ji. 5th edition.Varanasi: Choukhamba Sanskrit Sansthan;2007. Pp.738, p.458

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Annexure S.D.M. COLLEGE OF AYURVEDA & HOSPITAL, UDUPI. DEPARTMENT OF P.G. STUDIES IN KAYA CHIKITSA

Patient Inclusion/Exclusion Form


Case Number ( Name: Address: Age: ) Sex : M/F

Screening of the Patient Symptoms Kandu P Site of lesions A Daaha P A Vaivarnya P A Rookshata P A Spreading P A Relapsing P A

Scalp, Face Neck ,Trunk, Hands, Wrists, Ankles, Feet , Fingers,Toes Exclusion Criteria

Diabetic Mellitus

RBS : ____ mg/dl

YES YES YES

NO NO NO SI No:

Lesion present in more than 50% of body IHD Case : ACCEPTED

REJECTED

Case Number ( Name: Address: Age:

) Sex : M/F

Screening of the Patient Symptoms Kandu P Site of lesions A Daaha P A Vaivarnya P A Rookshata P A Spreading P A Relapsing P A

Scalp, Face Neck ,Trunk, Hands, Wrists, Ankles, Feet , Fingers,Toes Exclusion Criteria

Diabetic Mellitus

RBS : ____ mg/dl

YES YES YES

NO NO NO SI No:

Lesion present in more than 50% of body IHD Case : ACCEPTED

REJECTED

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Annexure

Patients Consent Letter Form

zs Adxg D0iz z0i, Pvr Gq v gUz Rn v Uv Wn 0iUz CzsAi Csy w v


___________________ JA F Aq AidAi gAz gu qz, EZAz F AidAi Mq Mz. F CzsAiz sUP U szAiPUz Egz JAz wz. Ezg Gz zsP, zsPU vU vPAv U jnz. F P F AidAiMq w awz. Aiiz Pgt Pqz F AidAz Aiiz Azsz Az g DPg Ag U wz. AP: :

QAi Pg

zg Pg

I .. aged.. years R/O.. is exercising my free power of choice, hereby give my consent to be included as a trial subject in the clinical research subject AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA. I understand that I may be treated with drug for the disease with which I am suffering. I have been informed to my satisfaction the aim, objective of the clinical trial, ingredients of the trial drug treatment and follow up including laboratory investigations to monitor and safeguard my body functions as when required. I am also aware of the right to opt out of the trial at any time during the course of my treatment .I will not make any compensatory claim for any hazardous effects on me during the treatment.

Date Patients signature Patient has signed the declaration and has given consent. Signature of the research scholar

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

II

Annexure SDM COLEGE OF AYURVEDA AND HOSPITAL, UDUPI DEPARTMENT OF KAYA CHIKITSA IN P.G. STUDIES RESEARCH PROFORMA FOR M.D. (AYU) THESIS AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA
GUIDE: Dr. SHRIDHARA HOLLA , CO-GUIDE: Dr. G. SHRINIVASA ACHARYA

Scholar:
Dr. KATHIRIYA BHAVIN

I. PATIENT PROFORMA NameAge: yrs Sl.No: OPD/IPD: Date: Ward/Bed No: D.O.A: D.O.D : Treatment Started on : Treatment Completed on:

Sex: M/F Religion H/M/Ch Education UE/P/M/HS/GR/PG Marital Status M / UM/ W / D Socio-economic Status : VP/ LM / M / UM / R Occupation Postal address Place U / R
II.

CHIEF COMPLAINTS -

Pradhana vedana 1 2 3 4 5 6 7 Vedana-kandu/daha Vaivarnya- Arun/Tamra/shweta Ruksha/Parusha Kesh/Loma paridwamsi Ghana/bahaltva Spreading Relapsation

Duration

Site

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

III

Annexure III. History of Present Illness:1)Vaivarnya/Discolouration a) Onset of Discolouration b) Duration: c) Site of Discolouration: head&neck/face/arms/hands/wrists/trunk/legs/feet d) Colour: Arun/Tamra/shweta e) Character of lesion Nummular/anular/cricinate /arcuate/ gyrate/linear/grouped/ reticulate f) No of lesionsAt beginning Sudden/Gradual/Insidious Acute/sub acute/chronic

Present g) Factor aggravating the symptoms: chemicals/dyes/earrings/necklace/chappals/dust/pores/pollens/ spring/autumn h) Factor reliving the symptoms: 2) Kandu: a) Course : Progressive / Episodic / Continuous b) Severity : Mild, localized, relieved spontaneously or any local measures Intense or widespread. Relieved by systemic methods or spontaneously. Intense or widespread. Poorly controlled by treatment c) Site : head&neck/face//trunk/arms/hands/wrists /legs/feet/fingers/ toes d) Aggravating Factor : Seasonal / Diurnal / Nocturnal / dust/pores/pollens/food e) Relieving Factor : Seasonal / Diurnal / Nocturnal 3)Vedana/Pain : a) Character : Daha : b) Onset : Sudden / Gradual c) Site : head&neck/face//trunk/arms/hands/wrists /legs/feet/fingers/ toes

d) Course : Progressive / Episodic / Continuous e) Aggravating Factor : f) Relieving Factor :

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

IV

Annexure IV .Treatment taken so far: Type Ayurveda Allopathy Other Variety Shodhana/shaman Oral/parental Duration Effect

V. History of past IllnessBR.ASTHAMA Skin diseases

VI. Family history Relative Father Mother Wife / Husband Siblings Dead/Alive Health status History of shwitra

VII. Personal History 1) Ahara


a)Appetite- G/M/P b)Diet- Nature- Veg/Mix/Non-veg c) Break Fastd) Mid Morninge) Lunchf) Snacks in Eveningg) Habits- Samshana / Vishamashana / Adhyashana / Anashan / Pramitashan h) Fruits- Regular/ occasional i) Rasapradhana- M / A / L / K / T / KS / SR j) Any sp.allergy of perticular rasa/food: k) Supplementary Diet tea / coffee / milk / cold drinks l) Water Intake Every morning / during or After Lunch/ Dinner Day + Night Its Total m) Cold Beverages Regular / Occasional

n) Butter milk/Curds: Regular / Occasional o) Spicy FoodsRegular / Occasional p) Fried ItemsRegular/ Occasional q) Junk FoodsRegular/ Occasional r) Ice CreamRegular/ Occasional s) Fish/milk: Regular / Occasional

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Annexure 2)Vihar a) Nidra: Sound / Disturbed Day_____ hours / Night ______ hours If disturbed reason: Mental strain: Y/N If yes, since_______ b) Vyayama: Type of exercise: for _____ mins. c) Mental activity : Type of stress Reliving factors Aggravating factors Day / years of exposure d) Type of profession: Sedentary /Involves physical strain /Involves mental strain Since _______ day / years . e) Recreation entertainment:TV / Indoorgames / outdoorgames / Outing / others f) Sexual intercourse:. Frequency __________ times / day / week. g) Hours of work: _______ hrs / day. h) Bowels: Reg /irreg /formed / unformed /constipated frequency______ time / day i) Micturation: Dysuria / polyuria / Oliguria frequency _________ times/day J) Addictions : Habits Duration/ continued Smoking Alcohol Tobacco Snuff Others

Occasional / Regular

Stopped/ reduced

VIII. Gynecological history M.C._________ days. Regular / Irregular / Painfull , History of contraception Menarche/ Menopause_______years P__G__L__D__A__ Temporary: Mechanical / Chemical /Oral /Local / I.U.C.D Permanent: Tubectomy / Vasectomy / Hysterectomy
IX. Vital signs Pulse :_____ per min Temperature : ______ oF Respiratory rate : ______ per min

B.P :__________mm of Hg Heart rate :_______ per min

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

VI

Annexure X. Dashavidha pariksha


Prakrithi V/P/K/VP/PK/KV/KP/VK/ S Vikriti V/P/K Satva P/M/A Sara P/M/A Samhanana P/M/A Pramana H__ cms : Wt____ Kg Satmya P/M/A Ahara shakthi Abhyavarna shakthi Purvakalina : P/M /A Adyatana : P/M/A Jarana Shakthi Purvakalina : P/M/A Adyatana : P/M/A Vaya : Bala/Madhyama / Vriddha Vyayama shakthi P/M/A

XI.GeneralPhysicalexamination.
Built & nourishment : well /mod /poor. Ht: _____ cms. Wt: _____ kg BMI:____kg/m2 Pallor: P / A , Edema: P / A , Cyanosis: P / A , Ictrus: P / A , Lymphadenopathy: P / A

Throat : Thyroid: Normal / abnormal XII. Systemic ExaminationSystem Respiratory Cardiovascular Per abdomen Urogenital Musculo skeletal Skin ExaminationINSPECTION: 1) Extent&DistributionSymmetrical/asymmetrical/localized Findings

2) Color of skin: Hypo pigmentation Hyper pigmentation ColorGeneralised/ liocalised Persistent/ Intermittent 3) State of skin: Sweating- absent/increased/decreased/normal/local/general Cold & Clammy skin- P/A Greasiness- P/A Wrinkling- P/A Tense skin- P/A Elasticity- N/I/D Thickness- N/I/R

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE VII COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Annexure Primary lesions Primary lesion Macule Shape Size Colour Distribution Margin Surface

XIII. Investigations Routine Hematological Investigation.


Results Hb% (12-18gm%) T.C. (4000 -11,000 cells/cumm) D .C N L E M B 40-70; 20-40;0-6; 0-6; 0-1 E.S.R (0-30 mm/hr) R.B.C (3.8-5.2 million/ Cumm)

XIV. Nidana panchaka: 1) Nidana a)Aharaja: Viruddha aharaTila+guda+dadhi lavana+dugdha matsya+dugdha milk+amla dravya

Garishta ahara- curd,fish,fermented food,drava,guru,sneha bahula,gramya anoopa uadaka mamsa sevana Fast foods idli,dosa,pizza,burger,sandwitch Asatmya aharasour food like cocum,pickle,vinegar,cold drinks,backing

powder,ushna-teekshna ,vidahi ahara,mulaka,garlic,onion,excessive intake of tila lavana amla and navannapana, b)Viharaja Vega dharana,ati vyayama after eating,Panchakarma apachara, after excersise/sun

exposure/fear taking cold water Exposure to sun after heavy meal,divasvapna,Living in polluted environment,Allergy to any substancec)Manasika2) RUPA Vata Roukshya Parushata Aruna/ Krishna Pitta Daha Roma vidwmsi Tamra / kamal patra vat varnata Snigdhata Kapha Kandu Bahal / Ghana Shveta varnata bhaya,chinta shoka krodha etc

varna mandala Kesh paridwamsi

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE VIII COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Annexure

3) DUSYATAHA PARIKSHA RAKTA-Rakta varna,kandu,durgandha. Tvak sparshahani,rukshata,sveda,kandu vaivarnya Mamsa - Tamra varna,bahala, sthira. Meda- shweta varna. 4) SAMPRAPTI GHATAKA Nidana Dosha Dushya Srotas Sroto dusti Agni Ama Udbhava sthana Sanchara sthana Vyakta sthana Roga marga : Aharaja/Viharaja/ Manasika : V/P/K : Tvak/Rakta/mamsa/Meda : Rasa/Rakta/Mamsa : : vishama /tikshns/manda/sama : Jatharagni / Dhatwagni : Amasaya / Pakwasaya / Ama pakwasaya : : : Bahya

5) VYADHI VINISCHAYA: Shwitra: Vaivarnya Shyava Tamra Shweta/kandu/Daha. 6) SADHYASADHYATA : 7) UPADRAVA :

XV. CHIKITSA: a) Oral administration of 1. Gomutra ghan vati 1 gm tid (A.C.) 2. Shashilekha vati 125 mg tid (A.C.) Anupana 10 ml Bakuchi taila for 28 days medication b) Diet & regimen: Avoid hot oily spicy food

Avoid contact with causative factor


AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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Annexure

XVI. ASSESSMENT CRITERIA : SUBJECTIVE CRITERIA: Twak shwethata Arun varnata Tamra varnata Twak rukshta Daha Roma vivarnata Kandu B.T. OBJECTIVE CRITERIA: Body region Number of patches Colour Size Number of black spots B.T.

VIDA score

AFTER TREATMENT /VISIT AT 28TH DAYS Name: Age: SUBJECTIVE CRITERIA: Twak shwethata Arun varnata Tamra varnata Twak rukshta Daha Roma vivarnata Kandu A.T.1

Date: Sex : A.T.1

OBJECTIVE CRITERIA: Body region Number of patches Colour Size Number of black spots

Systemic ExaminationIntegumentary system Respiratory System Cardiovascular System Central Nervous System Gastrointestinal System Adverse effect during treatment: yes/no If yes :

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

Annexure

AFTER TREATMENT /VISIT AT 56TH DAYS Name: Age: SUBJECTIVE CRITERIA: Twak shwethata Arun varnata Tamra varnata Twak rukshta Daha Roma vivarnata Kandu Systemic ExaminationIntegumentary system Respiratory System Cardiovascular System Central Nervous System Gastrointestinal System A.T.2

Date: Sex : A.T.2

OBJECTIVE CRITERIA: Body region Number of patches Colour Size Number of black spots

Adverse effect during treatment: yes/no If yes :

Signature of the Guide

Signature of Co-guide

Signature of the Scholar

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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BEFORE TREATMENT AFTER TREATMENT

AN OPEN EXPLANATORY CLINICAL TRIAL WITH A PRE-TEST AND POST-TEST DESIGN EVALUATING THE COMBINED THERAPEUTIC EFFECT OF SHASHILEKHA VATI AND GOMUTRA GHAN VATI IN SHWITRA

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INTRODUCTION

OBJECTIVES

REVIEW OF LITERATURE

DRUG REVIEW

ANALYTICAL STUDY

METHODOLOGY

OBSERVATIONS & RESULTS

DISCUSSION

CONCLUSION

SUMMARY

BIBLIOGRAPHIC REFERENCES

ANNEXURE