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CTRI Number  CTRI/2025/07/090093 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study on 40 Fistula-in-Ano(Bhagandara) Patients Treated With Ayurveda. Ksharasutra Therapy to Assess its Efficacy. 
Scientific Title of Study   A randomized controlled clinical trial to evaluate the efficacy of langali ksharasutra in the management of bhagandara. 
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 Hafis Muhammed KM 
Designation  PG Scholar 
Affiliation  Alvas Ayurveda Medical College 
Address  PG Department of Shalyatantra, Alvas Ayurveda Medical College, Moodubidire, Vidyagiri, Dakshina Kannada, Karnataka 574227

Dakshina Kannada
KARNATAKA
574227
India 
Phone  8921863186  
Fax    
Email  hafizhafiz3526@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukesh A 
Designation  Professor 
Affiliation  Alvas Ayurveda Medical College  
Address  PG Department of Shalyatantra, Alvas Ayurveda Medical College, Moodubidire, Vidyagiri, Dakshina Kannada, Karnataka 574227

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9845274680  
Fax    
Email  sukeshsdm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sukesh A 
Designation  Professor 
Affiliation  Alvas Ayurveda Medical College  
Address  PG Department of Shalyatantra, Alvas Ayurveda Medical College, Moodubidire, Vidyagiri, Dakshina Kannada, Karnataka 574227

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9845274680  
Fax    
Email  sukeshsdm@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical College, Moodubidire Karnataka India 574227 
 
Primary Sponsor  
Name  Dr Hafis Muhammed KM 
Address  PG Department of Shalyatantra Alvas Ayurveda Medical College, Moodubidire, Vidyagiri, Dakshina Kannada, Karnataka 574227 
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 Hafis Muhammed KM  Alvas Ayurveda Medical College  OPD ,PG Department of Shalyatantra,Alvas Ayurveda Medical College, Moodubidire, Vidyagiri, Dakshina Kannada, Karnataka 574227 KARNATAKA
Dakshina Kannada
KARNATAKA 		 8921863186

hafizhafiz3526@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clincal ethics commitee alvas ayurveda medical college vidyagiri moodbidri india  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Chakradatta Bhagandara Chikitsa 46/4, Procedure details: langali ksharasutra is administered in trial group where Ksharasutra taken through the external opening of the tract & pulled out through anal orifice & it is tied outside anal orifice .New thread is changed once per every week till its cut off or until 60 days. later once in every week for one month follow up is taken.)
2Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Chakradatta Bhagandara Chikitsa 46/4, Procedure details: Apamarga ksharasutra is administered in standard group where Ksharasutra taken through the external opening of the tract & pulled out through anal orifice & it is tied outside anal orifice .New thread is changed once per every week till its cut off or until 60 days. later once in every week for one month follow up is taken.)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.The patients having classical symptoms of Bhagandara will be selected.
2.Patients will be selected between the age group of 16 -70 yrs. of either gender, irrespective of religion, occupation, economic status.
3.Controlled systemic illness like Hypertension, Diabetes Mellitus etc.

 
 
ExclusionCriteria 
Details  1.Patients suffering secondary to inflammatory diseases like Ulcerative colitis and Crohn’s disease.
2.Fistula in ano associated with Multiple tracts, Fissure in Ano, Hemarrhoids, Anal stricture, Malignancy and Polyps.
3.Patients suffering from HIV, Tuberculosis, CA of rectum and Hepatitis B.
4.Pregnant women. 
 
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   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of treatment will be assessed on the basis
of gradation of both subjective and objective
parameters before and after treatment. 		 Follow up once every week for one month after study period 
 
Secondary Outcome  
Outcome  TimePoints 
Length of tract (in cm)

Unit Cutting Time :- "Total number of days taken for cut through" /"Initial length of track in cm" = days /cm
 		 Follow up once every week for one month after study period 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   14/07/2025 
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="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  
RANDOMIZED CONTROLLED CLINICAL TRIAL :- Evaluating the efficacy of langali ksharasutra in Management of Bhagandara using two study groups .In Group A (Standard group) Apamarga ksharasutra will be used and in  group B (Trial group) Langali ksharasutra is used for ligation of tracts. Total study period including follow up will be upto 90 days, (where ksharasutra is changed each week up to 60 days or till tract cut off. It will be followed by follow up once in every week for one month).Outcome assessed through subjective and objective parameters. 
 
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