RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE—KARNATAKA

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT

FOR DISSERTATION

“A CLINICAL COMPARATIVE STUDY OF ARKA KSHARA

SUTRA AND KADALI KSHARA SUTRA IN THE

MANAGEMENT OF BHAGANDARA w.s.r. to FISTULA-IN-ANO”

BY

DR. SAURABH TIWARI

1st YEAR P.G. SCHOLAR

DEPT. OF POST GRADUATE STUDIES IN SHALYA TANTRA

GUIDE

DR. M.R. SUBBA RAJU M.D. (Ayu.)

PROFESSOR AND H.O.D

DEPT. OF PG STUDIES IN SHALYA TANTRA

2012-2013

RAJIV GANDHI EDUCATION SOCIETY’S AYURVEDIC

MEDICAL COLLEGE, HOSPITAL P.G. STUDIES AND

RESEARCH CENTRE, RON-582209 DIST.:- GADAG

(KARNATAKA)

1

APPLICATION FOR APPROVAL OF PROJECT PROPOSAL

From,

DR. SAURABAH TIWARI

First Year M.S. (Ayu.) scholar

Department of Post Graduate studies in Shalya Tantra.

RGES Ayurvedic Medical College, Hospital P.G. Studies & Research Centre,

Ron Dist:-Gadag. (Karnataka)

To,

The Registrar,

Rajiv Gandhi University of Health Sciences,

Bangalore, Karnataka.

Through,

The Principal and Head of the Department of Shalya Tantra, RGES Ayurvedic

Medical College, Hospital P.G. Studies & Research Centre, Ron, Dist:- Gadag,

Karnataka.

Respected Sir/Madam,

SUBJECT:- Submission of completed proforma for registration of subject for

dissertation.

I request you to kindly register the below mentioned subject against my name

for the submission of dissertation to the Rajiv Gandhi University of Health Sciences,

Bangalore for partial fulfilment of M.S.(Ayurveda) course in Shalya Tantra.

TITLE OF DISSERTATION:-

“A CLINICAL COMPARATIVE STUDY OF ARKA KSHARA SUTRA AND KADALI KSHARA SUTRA IN THE

MANAGEMENT OF BHAGANDARA w.s.r. to FISTULA-IN-ANO”

Here with I am enclosing the completed proforma for registration of subject for Dissertation.

Thanking you,

Date:- 26/04/2013 Yours faithfully,

Place:-Ron Dr.Saurabh Tiwari

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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE -- II

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR

DISSERTATION

1) Name of Candidate : DR.SAURABH TIWARI

Address (In block letter) : 1st Year M.S. [AYU] SCHOLAR,

DEPT. OF P.G. STUDIES SHALYA TANTRA

RGES AYURVEDIC MEDICAL COLLEGE,

HOSPITAL POST GRADUATE STUDIES

AND RESEARCH CENTRE, RON-582209

DIST:-GADAG, KARNATAKA

Permanent Address : 498.B SHIVAJI NAGAR, NEAR GYAN

STHALY INTER COLLEGE DIST. - JHANSI

284001 UTTAR PRADESH

2) Name of the Institution : RGES AYURVEDIC MEDICAL COLLEGE,

HOSPITAL POST GRADUATE STUDIES

AND RESEARCH CENTRE, RON-582209

DIST:-GADAG, KARNATAKA

3) Course of Study & Subject : AYURVEDA DHANVANTARI

M.S. (AYURVEDA) IN SHALYA TANTRA

4) Date of Admission of Course : 30-10-2012

5) Title of the Topic :

“A CLINICAL COMPARATIVE STUDY OF ARKA KSHARA

SUTRA AND KADALI KSHARA SUTRA IN THE

MANAGEMENT OF BHAGANDARA w.s.r. to FISTULA-IN-ANO”

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6) BRIEF RESUME OF INTENDED WORK:-

6.1) NEED FOR THE STUDY:-

Fistula-in-ano is one of the most common ailments pertaining to ano-rectal

region. This disease causes discomfort and pain to patient, which creates problems in

routine work. In Ayurvedic classics, this disease has been described with the name of

BHAGANDARA and included under Ashtamahagada.[1] Most of the symptoms

correlates with fistula-in-ano.

The prevalence rate of fistula-in-ano is 8.6 cases per 100,000 population. The

prevalence in men is 12.3 cases per 100,000 population, and in women 5.6 cases per

100,000 population. The male-to-female ratio is 1.8:1.The mean age of patients is

38.3 years. [2]

As the wound is located in anal region which is more prone for contamination

and repeated infection, takes long time to heal and the condition remains

troublesome, operative procedures often leads to complications like recurrences and

incontinence.[3] In contemporary medical science the fistulotomy and fistulectomy

procedures need prolonged hospitalization and long duration of treatment. To

alleviate such problems in the management of this disease, it was thought to find out

alternative technique to treat these cases without operative complications.

The concept of management through Kshara Sutra was mentioned long back

by Acharya Susruta [4] and Chakradatta, [5] which has both cutting and healing

properties in the effective management of Bhagandara. Acharya Susruta dedicated

one whole chapter namely Kshara paka vidhi adhyaya. In that described various

kshariya dravyas [6] and one chapter in Chikitsa Sthana where he advocated the use of

kshara sutra in Bhagandara. [4]

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As the Kshara Sutra treatment has become standardized and popular, various

Kshariya drugs have been explored in the form of Kshara Sutra. There are many

Kshariya dravyas which were explained in the classics. Arka [7] and Kadali [7] are two

among them. So, Arka and Kadali Kshara Sutra is a new scope in this field . Kshara

Sutra procedure is economically affordable, easy to implement, with minimal side

effects and no hospitalization is needed.

As research work has already done on Arka Kshara Sutra and Kadali Kshara

Sutra Separately in various institutions, the present study has been selected to compare

the Efficacy between these two. Thus, a clinical comparative study of Arka Kshara

Sutra and Kadali Kshara Sutra has been taken up.

6.2) REVIEW OF LITERATURE:-

1. DISEASE REVIEW:-

The disease Bhagandara is explained under the Ashtamahagada [1], its nidana,

samprapti, lakshana, Chikitsa are explained in Susruta Samhita Nidana Sthana [8] and

Chikitsa Sthana [9], Bhavaprakasha Vol.2 Madhyama and Uttarkhanda [10], Madhava

Nidana Uttrardha [11], Rasa Ratna samuchhaya [12].

According to the contemporary medical science the disease review is

explained in all the surgery text books like Bailey & love’s , short practice of

surgery[13], A Concise textbook of Surgery; S.Das.[14] , Manipal manual of surgery[15]

etc.

2. DRUGS REVIEW:-

The formulation of Arka Kshara & Kadali Kshara is explained in Susruta Samhita,

Sutra Sthana Kshara paka vidhi adhyaya, 11th Chapter and Sloka- 12.

6.3) PREVIOUS WORK DONE:-

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1. Dr. Vikas S Yadav- Effect of Kadali Kshara sutra in the Management of

Bhagandara, SDM College of Ayurveda & Hospital Hassan. Rajiv Gandhi

University of Health Sciences, 2010

2. Dr. Kshirsagar Nagendra - Comparative Clinical Study in the Management of

Bhagandara with Vasa Kshara Sutra and Apamarga Kshara Sutra, N K

Jabshetty A.M.C. & P.G. Research Centre, Bidar, Rajiv Gandhi University of

Health Sciences, 2009

3. Dr. Pharande Mayur Uttam - Effect of Guggulu Kshara Sutra in Bhagandara,

SDM College of Ayurveda. Kuthpady, Rajiv Gandhi University of Health

Sciences, 2009

4. Dr. Samir Ahmad Gulab Chaudhari - Efficacy of Patankarma with Apamrgadi

lepa in the management of Bhagandara, N K Jabshetty A.M.C. & P.G.Centre

Bidar, Rajiv Gandhi University of Health Sciences, 2008

6.4) OBJECTIVE OF THE STUDY

1. Detail study of Bhagandara in Ayurvedic classics.

2. Study in detail about etiopathogenesis & management of fistula-in-ano, in

modern literature.

3. To compare the effect of Arka Kshara Sutra and Kadali Kshara Sutra in the

management of Bhagandara (Fistula-in-ano).

7) MATERIALS AND METHODS:-

7.1) Source of Data:

a. Literary source – The Literature of Bhagandara is collected from the various

classical texts of Ayurveda & Modern Science, updated with journals and internet.

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b. Clinical source - Patients will be randomly selected from the OPD & IPD of the

Dept. of Shalya Tantra of RGES Ayurvedic Medical College, Hospital Post Graduate

Studies and Research Centre, Ron, Dist. – Gadag, Karnataka.

c. Drugs- The trial drugs are collected from the local area and certified by the Dravya

Guna department.

I) Arka (Calotropis procera)

Part used- Panchang

II) Kadali (Musa paradisiaca)

Part used- Panchang

Preparation of Kshara Sutra:-

Arka Kshara Sutra and Kadali Kshara Sutra will be prepared similarly as per

the preparation of standard Apamarga Kshara Sutra. [16]

7.2) Method of Data Collection:

Study will be carried out in the patients fulfilling the diagnostic criteria of Bhagandara.

a) INCLUSION CRITERIA:-

The patients are diagnosed as per classical texts.

Patients will be selected between the age group of 16 -70 yrs. of either sex,

irrespective of religion, occupation, economic status.

Low anal fistula.

b) EXCLUSION CRITERIA:-

Patients with high anal/ rectal fistula.

Recurrent fistula-in-ano.

Patients suffering from systemic diseases like- Diabetes Mellitus, Hypertension.

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Patients suffering from inflammatory diseases like- Ulcerative colitis & Crohn’s

disease.

Patients suffering from infectious disease like- H.I.V., Tuberculosis.

DIAGNOSTIC CRITERIA

Signs & Symptoms

Pain

Itching

Discharge

Local tenderness

Induration

Length of tract (in cm)

STUDY DESIGN:-

Single blind clinical comparative study with pre and post test design.

SAMPLE SIZE:-

A minimum of 40 patients, 20 in each group will be selected by Simple

randomized sampling procedure. All the patients will be screened out by inclusive and

exclusive criteria and registered for clinical trial divided into two equal groups.

GROUP A: 20 patients are treated with Arka Kshara Sutra.

GROUP B: 20 patients are treated with Kadali Kshara Sutra.

DURATION- It depends on the length of fistulous tract, which is approximately 1cm

cutting time of the tract in 7 days as reported in various studies.

FOLLOW UP- After cutting of the fistulous tract the patients will be advised to

review once in a week, for four weeks.

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SOURCE OF FORMULATION:

According to the classical references Arka Kshara Sutra and Kadali Kshara

Sutra will be prepared in the Rasa shastra & Bhaisajya kalpana Dept. of RGES

Ayurvedic Medical College, Hospital Post Graduate Studies and Research centre,

Ron, Dist. - Gadag, Karnataka.

ASSESSMENT OF RESULTS

Depending upon subjective & objective parameters, assessment of response

will be made based on Gradation Index mentioned below.

Statistical analysis will be made using unpaired‘t’ test.

PARAMETERS OF STUDY:-

The improvement provided by therapy will be assessed on the basis of classical signs

and symptoms. All the signs and symptoms will be assigned with a score depending

upon their severity to assess the effect of the drugs objectively.

CRITERIA FOR ASSESMENT:

Assessment will be done based on the following parameters.

GRADING FOR THE ASSESSMENT CRITERIA:-

FOR SUBJECTIVE CRITERIA:-

1. Pain

Grade 0 - No pain

Grade 1 - Mild pain

Grade 2 - Moderate pain

Grade 3 - Severe pain

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2. Itching

Grade 0 - No itching

Grade 1 - Itching sometimes but not interfering with activities and can be

controlled voluntarily

Grade 2 - Itching, interfering with function, involuntary, uncontrolled and

associated with skin patches.

Grade 3 - Itching that disturbs the sleep and/or demand treatment associated

with skin patches.

3. Discharge

Grade 0 - No Discharge

Grade 1 - Mild discharge; single pad is sufficient per day.

Grade 2 - Moderate discharge; 2-3 pads are necessary per day

Grade 3 - Profuse discharge; more than 3 pads are necessary per day

FOR OBJECTIVE CRITERIA:-

1. Local tenderness: - Assessed by palpation of anal region.

Grade 0 - No tenderness

Grade 1 - Mild – tender but can be palpated.

Grade 2 - Moderate – tender on gentle palpation.

Grade 3- Severe – patient denies touching.

2. Induration

Grade 0 - Absent

Grade 1- Slight swelling around the wound margin without induration.

Grade 2 - Swelling around wound margin with little area of induration.

Grade 3 - Swelling with marked induration.

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3. Length of tract (in cm)

Unit cutting time: - Initial length of the tract – length of the tract remaining No of weeks taken

7.3 ) Does the study require any investigations or interventions to be conducted on Patients or other humans or animals? If so please describe: Yes Study will be a human observational study. No animal experimentation will be conducted.

INVESTIGATIONS:

Hb %,

TLC

RBS

Culture and Sensitivity of wound discharge (if necessity),

Fistulography (if necessity),

Any other investigation (if necessity)

7.4) Has ethical clearance been obtained from your institution in case of 7.3?

YES (Copy Enclosed)

8) LIST OF REFERENCES:-

1) Maharishi Susruta, Susruta Samhita Hindi translation with Ayurveda

Tattva Sandipika Purvardha-Sutra Sthana, Chapter-33, Sloka-4th Kaviraja

Dr.Ambikadatta Shastri Editor, Reprint Varanasi; Chaukhamba Sanskrit

Sansthan, 2008; .P.126

2) www.ncbi.nlm.nih.gov/pubmed/6508203 Sainio P. Fistula-in-ano in a

defined population. Incidence and epidemiological aspects. Ann Chir

Gynaecol. 1984;73(4): P.219-24. [Medline].

11

3) R.C.G. Russell, Norman.S.Williams and Christopher. J.K Bulstrode editor.

Bailey & Love’s, Short practice of surgery, Chapter-72, 24 th edition,

London Edward Arnold (publishers) Ltd.2004. p. 1268

4) Maharishi Susruta, Susruta Samhita Hindi translation with Ayurveda Tattva

Sandipika Purvardha-Chikitsa Sthana, Chapter-17, Sloka 30-33 Kaviraja

Dr.Ambikadatta Shastri Editor, Reprint Varanasi; Chaukhamba Sanskrit

Sansthan,2008;.P.81

5) Chakradatta, Sri Chakrapani Datta with Vaidyaprabhahindi

commentary Chapter-45, Sloka 11-13 Dr.Indradeva Tripathi Prof. Ramanath

Dwivedi editor, Reprint Varanasi., Chaukhamba Sanskrit Sansthan, 2005.

P.268

6) Maharishi Susruta, Susruta Samhita Hindi translation with Ayurveda

Tattva Sandipika Purvardha-Sutra Sthana, Chapter 11, Kaviraja

Dr.Ambikadatta Shastri Editor, Reprint Varanasi; Chaukhamba Sanskrit

Sansthan, 2008; .P.34-38

7) Maharishi Susruta, Susruta Samhita Hindi translation with Ayurveda Tattva

Sandipika Purvardha-Sutra Sthana, Chapter-11, Sloka-12th Kaviraja

Dr.Ambikadatta Shastri Editor, Reprint Varanasi; Chaukhamba Sanskrit

Sansthan,2008;.P.35

8) Maharishi Susruta, Susruta Samhita Hindi translation with Ayurveda Tattva

Sandipika Purvardha-Nidana Sthana, Chapter-4, Kaviraja Dr.Ambikadatta

Shastri Editor, Reprint Varanasi; Chaukhamba Sanskrit

Sansthan,2008;.P.244-246

9) Maharishi Susruta, Susruta Samhita Hindi translation with Ayurveda Tattva

Sandipika Purvardha-Chikitsa Sthana, Chapter-8, Sloka-4th Kaviraja

12

Dr.Ambikadatta Shastri Editor, Reprint Varanasi; Chaukhamba Sanskrit

Sansthan,2008;.P.45

10) Bhavaprakasha of Sri Bhavamishra Hindi translation Vol.-2 Madhya and

uttarkhanda, Chapter-50, Sloka 2-8,&14 Prof. K.R. Srikanthamurthy, editor

Reprint Varanasi; Chaukhamba Sanskrit Sansthan, 2002; .P.582- 584

11) Madhava Nidana,Vol II Chapter-46, Sloka1-8,Ayurvedacharya Sri

Yadunandana upadhyaya editor, 23rd Edition, Varanasi, Chaukhamba Sanskrit

Sansthan,1994.P.134-138

12) Rasaratna samuchaya of vagbhattacharya, Chapter-24, Sloka- 106-07 Dr.

Indradeva Tripathi editor, 2nd Edition Varanasi, Chaukhamba Sanskrit

Bhavan, 2000 .P.327-232

13) R.C.G.Russell, Norman.S.Williams and Christopher.J.K Bulstrode, editor.

Bailey & Love’s Short practice of surgery, Chapter-72, 24th edition, London

Edward Arnold (publishers)Ltd.2004.p. 1265-1268

14) Dr.S.Das editor. A Concise textbook of Surgery; Chapter-44, 6th edition

Kolkata; Dr S.Das 13 old mayors court(publishers) 2010.P.864-867

15) Dr. Rajgopal Shenoy K editor. Manipal manual of surgery, Chapter-31,

Reprint, New Delhi; Satish kumar jain for cbs publishers and distributors,

2007.P.529-531

16) Bhaisajya kalpana vijnanam, Chapter-4, Dr. K.Rama Chandra reddy editor, 1st

Edition Varanasi, Chaukhamba Sanskrit Bhavan,1998 P.356-357

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9) Signature of the student : (Dr. Saurabh Tiwari )

10) Remarks of the guide : In the today’s busy schedule the treatment

modality is simplified to save time. So this present research work can be

considered. Best of luck.

11.1) Name of Guide : Dr. M.R. SUBBA RAJU M.D. ( Ayu. )

& Designation Professor and P.G. Guide

Department of PG studies in Shalya Tantra,

RGES Ayurvedic Medical College, Hospital

PG Studies and Research Centre, Ron

11.2) Signature of Guide :

11.3) Co-Guide : Dr. M.R. HUNAGUNDI M.S.(Ayu.)

Lecturer,

Dept. of P.G. Studies in Shalya Tantra

RGES Ayurvedic Medical College, Hospital

P.G. Studies and Research Centre, Ron

11.4) Co-Guide Signature :

11.5) Head of the Department : Dr. M.R. SUBBA RAJU M.D.(Ayu.)

Professor, H.O.D. and P.G. Guide

Department of PG studies in Shalya Tantra,

RGES Ayurvedic Medical College, Hospital

P.G. Studies and Research Centre,

Ron-582209 Dist. Gadag, Karnataka

11.6) Signature of the HOD :

12.1) Remarks of the chairman : The above synopsis is scrutinized by the

And principal Post Graduate Studies and Research Centre

Committee of R.G.E.S.A.M.C and H, Ron and submitted for Registration as

subject of dissertation at R.G.U.H.S. Bangalore.

12.2) Signature : Dr. I.B. Kotturshetti M.D. (Ayu.)

Principal / C.M.O.

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