CTRI Number |
CTRI/2020/08/027481 [Registered on: 31/08/2020] Trial Registered Prospectively |
Last Modified On: |
31/08/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A Clinical study in the management of fistula in ano |
Scientific Title of Study
|
“A Clinical study on the efficacy of
Minimal Invasive Kshara-Sutra Technique (MIKST)
in the management of Bhagandara w.s.r. to High anal fistulaâ€
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR SUMIT BERWAL |
Designation |
M.S Scholar |
Affiliation |
National Institute of Ayurveda Jaipur |
Address |
National Institute of Ayurveda
Jorawar Singh Gate,Madhav Vilas,Amer Road Jaiour pin-302002 National Institute of Ayurveda
Jorawar Singh Gate,Madhav Vilas,Amer Road Jaiour pin-302002 Jaipur RAJASTHAN Pin-302002 India |
Phone |
9416995377 |
Fax |
- |
Email |
berwal85@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof P HEMANTHA KUMAR |
Designation |
Professor and HOD |
Affiliation |
National Institute of Ayurveda Jaipur |
Address |
National Institute of Ayurveda PG Department of shalya tantra
Jorawar Singh Gate,Madhav Vilas,Amer Road Jaipur pin 302002 National Institute of Ayurveda PG Department of shalya tantra
Jorawar Singh Gate,Madhav Vilas,Amer Road Jaipur pin 302002 Jaipur RAJASTHAN PIN-302002 India |
Phone |
9414056362 |
Fax |
|
Email |
profphknia@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Prof P HEMANTHA KUMAR |
Designation |
Professor and HOD |
Affiliation |
National Institute of Ayurveda Jaipur |
Address |
National Institute of Ayurveda PG Department of shalya tantra
Jorawar Singh Gate,Madhav Vilas,Amer Road Jaipur pin 302002 National Institute of Ayurveda PG Department of shalya tantra
Jorawar Singh Gate,Madhav Vilas,Amer Road Jaipur pin 302002 Jaipur RAJASTHAN PIN-302002 India |
Phone |
9414056362 |
Fax |
|
Email |
profphknia@gmail.com |
|
Source of Monetary or Material Support
|
National institute of ayurveda pharmacy jaipur |
|
Primary Sponsor
|
Name |
National Institute of Ayurveda Jaipur |
Address |
National Institute of Ayurveda PG Department of shalya tantra
Jorawar Singh Gate,Madhav Vilas,Amer Road Jaipur pin 302002 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Sumit Berwal |
NATIONAL INSTITUTE OF AYURVEDA HOSPITAL JAIPUR RAJASTHAN |
shalya tantra OPD No.28 , NIA, HOSIPITAL Jaipur RAJASTHAN |
9416995377
berwal85@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
MIKST TEchnique in High anal fistula |
Minimal Invasive Kshara Sutra Technique (MIKST) – First Probing from external opening to internal opening will be done, followed by a small incision at inter-sphinteric groove. Through this wound, Kshara Sutra will be applied towards internal opening and the plain thread towards external opening. The Kshara Sutra and Plain thread will change at weekly interval |
Intervention |
MIKST technique in high anal fistula in ano |
Minimal Invasive Kshara Sutra Technique (MIKST) – First Probing from external opening to internal opening will be done, followed by a small incision at inter-sphinteric groove. Through this wound, Kshara Sutra will be applied towards internal opening and the plain thread towards external opening. The Kshara Sutra and Plain thread will change at weekly interval |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Male or female between age 20 to 60 years and willing to give their written informed consent.
2. No major systemic disease involved.
3. Patients who have signs and symptoms of Bhagandara /Fistula-in-ano of length more than 4cm from anal canal.
4. Patients who have signs and symptoms of High anal fistula and Trans-sphincteric fistula.
5. Recurrent High anal fistula and Trans-sphincteric fistula. |
|
ExclusionCriteria |
Details |
1. Male or female less than 20 years and greater than 60 years of age.
2. Patient with known hypersensitivity to any of the components of the formulation.
3. Fistula of length less than 4 cm from anal canal.
4. Supra-sphincteric and Extra-sphincteric fistula.
5. Multiple fistulas. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the efficacy of Minimal Invasive Kshara Sutra Technique (MIKST) in the management of Bhagandara (High anal fistula) |
3 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate the better surgical methods in fistula in ano. |
3 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
01/10/2020 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
In Ayurveda, Bhagandara has been mentioned as one among the Ashtomahagada (eight major diseases) because of its callous attitude. The references of Bhagandara can be traced back to Garuda Purana. Detailed description of Bhagandara is mentioned in Susruta Samhita in Chikitsa Sthana 8thchapter. Bhagandara can be compared to Fistula-in-ano in modern science on the basis of similarities in the symptomatology mentioned in Ayurveda and Modern text books. Bhagandara (Fistula-in-ano) is one of the oldest diseases known to the Medical Science. Fistula-in-ano is a common ano-rectal condition prevalent in the population worldwide and its prevalence is second after hemorrhoids. Hippocrates made reference to surgical Therapy for Fistula-in-ano. In 1376, the English Surgeon John Arderne (1307-1390 AD) wrote treatises of Fistula-in-ano, Hemorrhoids and clysters which described Fistulotomy and use of Seton in Fistula-in-ano. In the 19 century Goodsall and Miles, Milligan and Morgan, Thompson, Lockhart Mummery and Parks made substantial contribution in description and treatment of Fistula-in-ano. Acharya Susruta has mentioned that all types of Bhagandara are difficult to treat3. In modern Surgery also it is known for its callous nature towards cure and recurrence rate. According to a recent survey conducted by Sainiop4 on the prevalence rate of Fistula-in-ano in a London based hospital is 8.6 cases per 1,00,000 population. In men: 12.3 cases per 1,00,000 population and in women: 5.6 cases per 10,000 population, Male:female = 1.8:1, Mean age of patient: 38.3 years. 10% of all indoor patients and 4% of all outdoor patients were reported to be suffering from this disease. A similar study conducted in India has reported that Fistula-in-ano constitutes about 15-16 % of all ano-rectal disorders. It is being managed by specialized Proctologists and Surgeons. But inspite of all the possible efforts, the recurrence rate is very high i.e. 20 to 30% which is a big challenge before the surgeon’s community. |