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CTRI Number  CTRI/2025/03/082825 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Efficacy of Apamarga Kshara Sutra ligation in figure of eight technique in fistula in ano 
Scientific Title of Study   A Randomized controlled open labelled clinical study to evaluate the efficacy of Apamarga Kshara Sutra ligation in figure of eight technique in the management of Bhagandara with special reference to 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  Dr Shreya sharma 
Designation  PG Scholar 
Affiliation  Jammu Institute of Ayurveda and Research 
Address  Department of Shalya Tantra Jammu Institute of Ayurveda and Research Nardni Raipur Bantalab road Jammu and Kashmir India 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone    
Fax    
Email  shreyasharma1897@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harvinder singh bali 
Designation  Professor 
Affiliation  Jammu Institute of Ayurveda and Research 
Address  Department of Shalya Tantra Jammu Institute of Ayurveda and Research Nardni Raipur Bantalab road Jammu and Kashmir India 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9906188779  
Fax    
Email  Drharvindersinghbali.8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harvinder singh bali 
Designation  Professor 
Affiliation  Jammu Institute of Ayurveda and Research 
Address  Department of Shalya Tantra Jammu Institute of Ayurveda and Research Nardni Raipur Bantalab road Jammu and Kashmir India 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9906188779  
Fax    
Email  Drharvindersinghbali.8@gmail.com  
 
Source of Monetary or Material Support  
Jammu institute of Ayurveda and Research Nardani Raipur Bantalab road Jammu and Kashmir India 181123 
 
Primary Sponsor  
Name  Jammu institute of Ayurveda and Research 
Address  Jammu institute of Ayurveda and Research Nardani Raipur Bantalab road Jammu and Kashmir India 181123 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Shreya Sharma  Jammu institute of Ayurveda and Research  Department of Shalya Tantra Second floor Jammu Jammu and Kashmir India 181123
Jammu
JAMMU & KASHMIR 		 7051354235

shreyasharma1897@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jammu institute of Ayurveda and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushruta Samhita Chikitsa sthan chapter 17 shloka 33, Procedure details: After probing the internal & external openings are identified & tract of fistula is located & along that tract kshara sutra ligation is done )
2Intervention ArmProcedure-kshara sutra ligation in figure of eight technique (Procedure Reference: Novel technique, Procedure details: In this new figure of eight technique ,one extra opening in the middle of the external and internal openings of the tract of fistula will be created then with the help of a malleable probe kshara sutra ligation in the figure of eight technique will be done and after every one week patient will be examined till complete healing of fistula tract)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with fistula in ano
2. Patients reluctant to modern surgical technique
3. Age group 18 to 60 years of age
4. Low anal fistua 
 
ExclusionCriteria 
Details  1. Patients of less than 18 years of age and more than 60 years of age
2. High anal fistula
3. Patients suffering from fistula in ano associated with tuberculosis diabetes COPD or any other systemic ailment
4. Trans sphincteric high anal fistula
5. Inter sphincteric high anal fistula
6. Patients with positive result of any viral marker test
7. Patients with Hb below 10 gm/dl
8. Pregnancy
9. Unwilling patient
 
 
Method of Generating Random Sequence   Other 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Pain
2. Burning sensation
3. Discharge
4. Itching
5. Inflammation 		 Baseline
After 7th day,14th day,21st day,28th day till complete healing of fistula tract 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of unit cutting time & length of tract  Baseline, 1 week, 4 weeks 
 
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 2 
Date of First Enrollment (India)   15/04/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Conservative treatment of fistula in ano is not at all successful because of its callus nature . Even today when modern surgery is at its peak , fistula in ano is still a  challenge for the surgeons for its prolonged  healing period , post operative complications and incidence of recurrence . Management of anorectal disorders with Ayurveda is becoming more popular especially in fistula in ano . Kshara sutra is a medicated thread that works on the principle of cutting the tract, scrapping the unhealthy granulation tissue and healing of the tract.
The Bailey’s and love short practice of surgery has, in its 25 th edition , included kshara sutra  as a treatment method for fistula in ano while describing various methods for its treatment.
Moreover, when this kshara sutra ligation will be done in figure of eight technique  it may significantly reduce the duration of healing period of the tract of fistula , thus aiding speedy recovery.
Fistula in ano has two openings one internal opening and one external opening. with the help of probing, the internal opening and tract of the fistula is identified and kshara sutra ligation is done. but in this new figure of eight technique, one extra opening in the middle of the external and internal openings of the tract of fistula will be created. Then with the help of a malleable probe kshara sutra ligation in the figure of eight technique will be done. This new figure of eight technique may reduced the duration of the healing of the tract of fistula significantly when compared to classical kshara sutra ligation.
 
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