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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: PARISRAVI-BAGANDARAH/SLESHMAJA-BAGANDARAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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. |