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CTRI Number  CTRI/2025/06/089595 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study on Reapproving of Sushruthas Circular incision followed by Alkali application in Fistula in ano 
Scientific Title of Study   An open label single arm clinical study on Revalidation of Sushrutokta Chandrachakra incision followed by Kshara karma in Parisravi 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 Shubha M M  
Designation  2nd year PG scholar 
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical College and Hospital Mysuru -570028, Karnataka.
Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical College and Hospital Mysuru -570028, Karnataka.
Mysore
KARNATAKA
570028
India 
Phone  7019654002  
Fax    
Email  shubha1999mm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Siddayya Aradhya math 
Designation  Professor and HOD  
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical College and Hospital Mysuru -570028, Karnataka.
Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical College and Hospital Mysuru -570028, Karnataka.
Mysore
KARNATAKA
570028
India 
Phone  9449972788  
Fax    
Email  dr.siddesharadyamath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubha M M  
Designation  2nd year PG scholar 
Affiliation  JSS Ayurveda Medical College and Hospital, Mysuru 
Address  Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical College and Hospital Mysuru -570028, Karnataka.
Department of PG and Ph.D studies in Shalya Tantra. JSS Ayurveda Medical College and Hospital Mysuru -570028, Karnataka.
Mysore
KARNATAKA
570028
India 
Phone  7019654002  
Fax    
Email  shubha1999mm@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital Mysuru 570028 
JSS Ayurveda Medical College and Hospital,Mysuru 570028  
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [] 
 
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 Shubha M M  JSS Ayurveda Medical College and Hospital   OPD no 10 , OPD and IPD of Department of Shaya tantra,JSS Ayurveda Medical College and Hospital, Lalithadripura road, Mysuru 570028
Mysore
KARNATAKA 
7019654002

shubha1999mm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearance Committee - Human  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: PARISRAVI-BAGANDARAH/SLESHMAJA-BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Bedana-karma, भेदन-कर्म (Procedure Reference: Sushruta samhitha , Procedure details: Chandrachakra incision will be taken over external opening excision of tract will be done followed by kshara karma.)
(1) Medicine Name: Tab gandaka rasayana , Reference: Yogaratnakara , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 28 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects fulfilling diagnostic criteria of Parisravi Bhagandara
Diagnostic criteria - Presence of external opening near anal canal, pain, itching, discharge. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women
2. Rectovaginal fistula, Rectovesical fistula, Rectoscrotal fistula
3. CA of rectum, HIV, Hepatitis B, uncontrolled DM
4. Fistula secondary to Tb, crohns disease, ulcerative colitis  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identifying the fistula tract, probing, chandrachakra incision followed by kshara karma procedure. Pain, pus discharge, itching,size of wound, induration, granulation tissue parameters will be assessed.  2 to 3 days  
 
Secondary Outcome  
Outcome  TimePoints 
Healed fistulous tract   Healed fistulous tract  
Subjective parameters like pain, pus discharge, itching will be assessed. Objective parameters like size of wound, induration, granulation tissue will be assessed.  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 3 
Date of First Enrollment (India)   06/07/2025 
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 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   Bhagandara is a chronic illness which is correlated to fistula in ano. Fistula in ano is an abnormal communication between epithelial lined surface having non healing unhealthy granulation tissue. In Ayurveda Acharyas have described Chedana karma for management of Bhagandara with different types of incision. 
The main aim and objective of the study is to revalidate Acharya Sushrutas Chandrachakra incision followed by kshara karma in Parisravi Bhagandara. Sample source - subjects fulfilling diagnostic criteria. Diagnosis by confirming following signs and symptoms of Parisravi Bhagandara after thorough digital, rectal, proctoscopic examination of subjects, like presence of external opening near anal canal, pain, itching, discharge.
Intervention - Pre operative procedure like physical fitness will be taken, inform and written consent will be taken, nil by mouth for 6 hours prior to surgery, part preparation followed by proctoglycerin enema will be given, injection TT intramuscular and injection lignocaine test dose subcutaneous will be given.
Operative procedure - under all aseptic precautions spinal anaesthesia will be given, part will be painted with povidone iodine solution and draped in the lithotomy position. External opening of fistulous tract will be identified and probed. Chandrachakra incision will be taken over external opening, excision of tract followed by kshara karma will be done. Complete hemostasis will be achieved. Anal packing will be done.
Post operative procedure - Subject will be shifted to post operative ward, catheterization will be done. Foot end elevation, restricted head movements will be advised. The vitals will be monitored every 2nd hourly. Liquid diet will be started orally after appreciable bowel sounds heard .
The following subjective and objective parameters will be assessed before and after surgery. Subjective parameters are pain, itching, discharge. Objective parameters are size of wound, induration, granulation tissue. These parameters will be assessed on 1st, 7th, 14th, 21st, 28th. On completion of treatment the subjects will be asked to visit the opd after 15 days. Paired t test, wilcoxon signed rank test will be made use of for statistical analysis.
 
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