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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)
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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].
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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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