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CTRI Number  CTRI/2025/06/088135 [Registered on: 03/06/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare Ksharsutra treatment and surgical procedures for peri anal fistula 
Scientific Title of Study   A Randomized Controlled Clinical Trial on The Effect Of “Ksharsutra treatment” (Ayurvedic Medical Seton) Vs Conventional Surgical Treatment in Clinical Outcomes of Patients with Fistula-In-Ano 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Professor Virinder Kumar Bansal 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no-405 4th Floor Surgery Block AIIMS New Delhi Pin-110049

South West
DELHI
110049
India 
Phone  9810348479  
Fax    
Email  drvkbansal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Professor Virinder Kumar Bansal 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no-405 4th Floor Surgery Block AIIMS New Delhi Pin-110049

South West
DELHI
110049
India 
Phone  9810348479  
Fax    
Email  drvkbansal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ansin Sreeraj S 
Designation  PG Surgery Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  Room no-405 4th Floor Surgery Block AIIMS New Delhi Pin-110049

South West
DELHI
110049
India 
Phone  6261446520  
Fax    
Email  ansinsreeraj1697@gmail.com  
 
Source of Monetary or Material Support  
AIIMS,New Delhi 
 
Primary Sponsor  
Name  Professor. Virinder Kumar Bansal 
Address  Room no- 405 4th floor Surgery Block AIIMS New delhi Pin- 11004 
Type of Sponsor  Other [self] 
 
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 Virinder Kumar Bansal  AIIMS,New Delhi  Room no- 405 4th floor Surgery block AIIMS New Delhi Pin-110049
South West
DELHI 
9810348479

drvkbansal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of ethics committee AIIMS of block Ansari Nagar New Delhi 29  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K603||Anal fistula, (2) ICD-10 Condition: K605||Anorectal fistula, (3) ICD-10 Condition: K604||Rectal fistula,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Surgery for fistula-in-ano, fistulotomy or fistulectomy   1.Fistulotomy The first step is identification of primary fistula tract using malleable probe. After passing probe from external opening through internal opening, diathermy is used to divide the perianal skin and anal epithelium. If few fibres of striated muscle of internal sphincter is involved, that may be divided. If substatntial amount of fibres are involved, division of muscle is not advisable and seton is inserted. If high blind tract is identified, it should be adequately curetted and drained. Any bleeding from the edges should be secured by cautery and gauze dressing applied. 2.Fistulectomy Similar to the fistulotomy, probe is inserted from external opening to internal opening and fistulous tract will excised using fine scalpel and cautery. All the tracts must be excised and cored out in complex fistula or multiple tracts. The defect in external sphincter may require closure and internal opening is closed with an anorectal advancement flaps.  
Intervention  Ksharsutra insertion for fistula-in-ano  After piercing the internal opening, the tip of the probe comes out through the anal canal. Ksharsutra is fixed through the ends of the metal probe and the two free ends of Ksharsutra are tied. Gauze pad dressing will be done and subsequently the thread will be changed once per week. Depending on the cutting and healing of the tract the duration can vary from patients to patients. The process is repeated until the thread cuts open the tract. The total time taken for complete healing of the fistula tract from start of treatment will be noted. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participants having low anal fistula (subcutaneous, submucosal, inter sphincteric fistula & trans sphincteric with less than 30% involvement of external sphincter) with single tract or multiple small tracts within 2-3 cm of each other and within 5 cm of anal verge diagnosed during clinical examination. 
 
ExclusionCriteria 
Details  1.Age < 20 years or >70 years
2.Severely immunocompromised or compromised cardio pulmonary status
3.Participants with uncontrolled comorbidities such as diabetes mellitus and hypertension
4.HIV/hepatitis B/VDRL positive
5.Colorectal carcinoma
6.Ulcerative colitis & Crohn’s patients
7.On anti-tubercular therapy
8.Fistulas other than ano-rectal like recto vaginal fistula etc.
9.Anterior fistula-in-ano in women & pregnant women
10.Osteomyelitis
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Guggulu-based Ksharsutra treatment vs. conventional surgical treatment in primary healing of fistula-in-ano   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the recurrence rates of anal fistula between the Guggulu-based Ksharsutra treatment & conventional surgical treatment during follow-up  3 months 
To evaluate the impact of both interventions on perianal symptoms including itching, discharge, burning sensation, pain, & anal incontinence at follow up  3 months 
To assess the unit cutting time & healing time associated with the Ksharsutra intervention  3 months 
To compare the duration of hospital stay & number of hospital visits required in both treatment groups.  3 months 
To evaluate the cost-effectiveness of Guggulu-based Ksharsutra treatment compared to surgical management.  3 months 
To assess the number of workdays lost due to the disease & its treatment in both groups  3 months 
To evaluate & compare the quality of life post-treatment using standardized tools such as the Gastrointestinal Quality of Life Index (GIQLI) & Fecal Incontinence Quality of Life Scale (FIQOL)  3 months 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
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 2 
Date of First Enrollment (India)   16/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   1.Fistula-in-ano is one of the most common inflammatory anorectal diseases affecting the perianal region including the sphincter muscles, ischioanal fossae, and the perianal skin

2. Ksharsutra is a widely accepted parasurgical treatment

3.This procedure has multitude of advantages over conventional surgical therapy; like it is an ambulatory procedure throughout the course of intervention and doesn’t require extensive hospital stays which is cumbersome to the patient and the treatment cost per patient is comparatively less . Ksharsutra has a better post procedural scarring, quality of life and less recurrence compared to the conventional surgery.It is observed that while performing Ksharsutra techniques sphincteric tone can be preserved leading to minimal incontinence in patients. Besides, Ksharsutra offers a relatively less invasive method for tackling fistula-in-ano as compared to surgery, which can have recurrence rates of 20%-40%, while exposing the patient to risk of anesthetic complications as well as prolonged hospital stay.

4.The Indian Council of Medical Research has validated [15] this therapy by conducting multicentric research trial and concluded that Ksharsutra is better than conventional surgery in fistula‑in‑ano.

5.over the years advancement in the field of Ayurvedic pharmaceutics has led to value addition & pharmaceutical modification in Ksharsutra. There has been a number of researches on the variants of classical Ksharsutra like nimba, aragwadha, udumbara Ksharsutra.One such modified form of classical Ksharsutra known as Guggulu Ksharsutra is also researched

6. This research study is proposed to compare the effect of Guggulu based Ksharasutra in Fistula-in-ano vs. conventional surgical treatment modalities to understand its effect in healing, recurrence and other morbidities associated with fistula-in-ano. This study also proposes to evaluate and put forward the findings to clinical practice. The treatment modalities will also be compared for the purpose of complete healing of fistulous tract while preserving sphincter complex and improving quality of life in these patients.



 
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