SCLEROTHERAPY IN BLEEDING PILES A COMPARATIVE STUDY BY PHENOL AND APAMARG KSHAR

Submitted to d.s.r.RAJASTHAN AYURVED UNIVERSITY JODHPUR (RAJASTHAN)

PROPOSED SYNOPSIS FOR THE DEGREE OF AYURVEDA DHANVANTARI [M.S.(Ay.)] Post graduate Department of shalya tantra NATIONAL INSTITUTE OF AYURVEDA, JAIPUR

Under supervision and guidance of GUIDE DR. J. P. VERMA M.D.(Ay.) Associate Professor CO-GUIDE DR. NARINDER SINGH M.S.(Ay.) Lecturer

SCHOLAR DR. ASHISH PAREEK P.G. Department of shalya tantra, National Institute of Ayurveda, Jaipur -302002

To, The Registrar, Rajasthan Ayurveda University, Jodhpur (Raj.). Through - Proper channel, Subject Application for the Registration of thesis for the award of post graduate degree of ayurved dhanvantari [M.S.] in the P.G. Department of Shalya Tantra,NIA,Jaipur. Respected Sir, With due respect, I am presenting herewith the synopsis of the thesis with necessary particulars for your kind perusal and permission please. Name of Scholar Father's Name Date of Birth Permanent Address : : : : Dr. ASHISH PAREEK Shri RAJENDRA KUMAR PAREEK 07/10/1987 131-132 SHRI RAM NAGAR, NEAR AVM SCHOOL, KALWAR ROAD, JHOTWARA, JAIPUR, RAJASTHAN ,PIN- 302012 RAU/06/777 B.A.M.S. in july 2012 P.G. Department of Shalya Tantra National Institute of Ayurveda, Jaipur. English, Sanskrit. " SCLEROTHERAPY IN BLEEDING PILESCOMPARATIVE STUDY BY PHENOL AND APAMARG KSHAR

Enrolment Number Previous Exam passed & Year Name of the Department Name of the Institution Language of Thesis Title of Dissertation

: : : : : :

GUIDE DR. J. P. VERMA M.D.(Ay.) Associate Professor SCHOLAR DR. ASHISH PAREEK

CO-GUIDE DR. NARINDER SINGH M.S.(Ay.) Lecturer

SCLEROTHERAPY IN BLEEDING PILES A COMPARATIVE STUDY BY PHENOL AND APAMARG KSHAR

INRODUCTION Sclerotherapy is a fixative procedure typically prescribed for treating small, internal, first or second degree hemorrhoids. The Sclerotherapy procedure employs a hardening chemical that scars the inflamed tissue, reducing the hemorrhoids blood -flow and thereby alleviating both the cause of the hemorrhoid and its symptoms. The sclerotherapy solution causes the vein to scar and collapse, forcing blood to reroute through healthier veins. The collapsed vein is reabsorbed into local tissue and eventually fades. AYURVEDIC VIEW Sclerotherapy is not a new technique it is modernization of ancient kshar karma. Kshar karma is indicated in Arsha chikitsa. Apamarg kshar is mentioned in Arsh chikitsa in chakradutt (Arsha chi./10). Kshar preparation method is thoroughly described in Susrut sutra sthan 11. NEED OF STUDY Currently available conservative treatment mode for bleeding piles is not so effective. Patient of hemorrhoids has hesitation about surgery. So there should be a way between oral drug therapy and surgery like sclerotherapy. With Sclerotherapy treatment, recovery time is shorter and the procedure threatens less risky side-effects; additionally, because the procedure can be done in O.P.D., it does not require a stay in the hospital. Sclerotherapy necessitates the patient adhere to strict protocol prior to, and after, the procedure has been performed. The phenol is very irritant in nature, and so painful. Sometimes it lead to sterile abscess in anal region. While Apamarg kshar is a herbal product and less irritant in nature, it may be a great substitute of phenol in sclerotherapy. CLINICAL STUDY: AIM: To evaluate and compare the efficacy of phenol and apamarg kshar by sclerotherapy. OBJECTIVES: To review and analyze available literature of Kshar karma explained in Ayurveda. To observe the therapeutic effect of Kshar karma using pratisarneeya kshar. To analyze the thermal behavior of fluid (kshar & phenol) to formulate mode of action of sclerotherapy.

 To innovate an ideally suitable procedure for performing Kshar karma.

Materials and methods:

The various materials required for the study along with their descriptions and method of application of the procedures is explained.

Materials:
1 Phenol (carbolic acid ) 2 Apamarg kshar 3 Menthol 4 Almond oil

Methodology:
1. SAMPLE SIZE: Total 30 subjects will be randomly selected for the study, with ages ranging from 20yrs to 60yrs, irrespective of sex, religion etc. 2. Source of data: Patients attending OPD and IPD of Post Graduate Department of Shalya Tantra, National Institute of Ayurveda, Jaipur will be selected for trial. During the course of selection a separate case proforma according to the protocol will be used for documentation. 3. INFORMED CONSENT: The study will be explained clearly to the subjects and their signed, written informed consent will be taken before starting the trial. 4. SELECTION CRITERIA: i. INCLUSION CRITERIA: 1. Patients of 20 - 60 year age group & any sex. 2. Patients having bleeding piles. 3. Patients who will be ready to give written informed consent.

ii. EXCLUSION CRITERIA: 1. 2 3 4 Patients with systemic diseases like Diabetes mellitus, Tuberculosis, etc. Infective, Neoplastic conditions of rectum. Pelvic pathology Pregnancy

A disease specific proforma will be prepared and the observations will be recorded after doing General, Systemic and Local examinations.

Investigations:
Blood routine: CBC, ESR HbsAg, HIV Blood sugar Urine examination Other investigations like tuberculin test, Pus culture, biopsy, FNAC etc. if needed.

STUDY DESIGN: In this clinical study 30 patients of bleeding piles will be selected on the basis of simple random sampling (SRS) procedure & will be distributed in 2 equal groups. After sclerotherapy analgesics will be used as per need.

POSOLOGY:-

SR. NO. 1.

PARTICULARS DRUG

GROUP- 1 phenol

GROUP- 2 Apamarg kshar

DOSE 2. APPLICATION METHOD DURATION 4.

3-4 ml

3-4 ml

3.

Injection in sub mucosal plane of a pile Thrice (at 1st ,3rd ,6th week)

Injection in sub mucosal plane of a pile thrice (at 1st ,3rd ,6th week)

FOLLOW UP: 1st, 2nd, 3rd , 4th ,5th ,6th ,7th and 8th week

Assessment criteria:
Effect of therapies will be evaluated before, during & after the course of treatment by using parameters as stated below4 with standard grading.

SUBJECTIVE PARAMETERS: Pain Functional ability Bleeding

OBJECTIVE PARAMETERS: Induration Tenderness Color Itching Discharge

Criteria for assessment:

Good response: complete relief in presenting signs symptoms of the disease. Fair response: 75% and above relief of signs symptoms. Poor response: 50% to 74% relief of signs symptoms. No response: No response in presenting signs symptoms of the disease

Results:
Results of the treatment will be tabulated and analyzed statistically with relevant tests and level of significance will be reported.

LAYOUT OF DISSERTATION: Acknowledgement Introduction Conceptual study Clinical study Aims & Objectives Materials and Methods

Drug review Observations Results Discussion Summary Conclusion References Bibliography Disease Specific Proforma / Case Sheet

GUIDE DR. J. P. VERMA M.D.(Ay.) Associate Professor

CO-GUIDE DR. NARINDER SINGH M.S.(Ay.) Lecturer

SCHOLAR DR. ASHISH PAREEK M.S.(AY.) SCHOLAR P.G. Department of shalya tantra, National Institute of Ayurveda, Jaipur -302002