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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 fistula”  
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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