| CTRI Number |
CTRI/2025/07/090978 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Apamarga kshar sutra and Gunja kshar sutra ligation in Bhagandara |
|
Scientific Title of Study
|
Comparative clinical evaluation of Apamarga kshar sutra and Gunja kshar sutra ligation in 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 |
Raghav Sharma |
| Designation |
PG scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road, Haridwar, Uttarakhand India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8557889495 |
| Fax |
|
| Email |
raghavsharma102030@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sachin Gupta |
| Designation |
HOD & Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road, Haridwar, Uttarakhand India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9419135050 |
| Fax |
|
| Email |
chintu.925@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sachin Gupta |
| Designation |
HOD & Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya Tantra, Patanjali ayurved hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road, Haridwar, Uttarakhand India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9419135050 |
| Fax |
|
| Email |
chintu.925@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar,Uttarakhand,India 249405 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Raghav Sharma |
Patanjali Ayurved Hospital |
OPD 15,Department of Shalya Tantra,Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, phase 1, Roorkee Road , Haridwar , Uttarakhand, India 249405
Hardwar
UTTARANCHAL |
8557889495
raghavsharma102030@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar,Uttrakhand |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Chakradatta Arshodhikar 5/148, Procedure details: Apamarga- Ksharsutra Ligation in fistulous tract locally & changed weekly till the whole tract is cut through (duration of treatment based on length of fistulous tract))
| | 2 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Chakradatta Arshodhikar 5/148, Procedure details: Gunja- Ksharsutra Ligation in fistulous tract locally & changed weekly till the whole tract is cut through (duration of treatment based on length of fistulous tract))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Clinical signs and symptoms of all types of Bhagandara
2) Patient age group ranging between 18-60 years of either sex
3) Patients who are willing for the trial
4) Newly diagnosed as well as pre-diagnosed cases of Bhagandara
|
|
| ExclusionCriteria |
| Details |
HBsAg, HCV and HIV positive patients.
Patient below 18 and above 60 years of age of either sex.
Pregnancy
Secondary fistulas due to: -
1) Crohn’s disease
2) Ulcerative colitis
3) Carcinoma of Rectum
4) Pelvic Abcess
5) Tuberculosis
6) Osteomyelitis of Pelvic Bone.
7) Patient having uncontrolled
Diabetes and Hypertension.
8) Other systemic disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters–
Itching
Burning sensation
Discharge
Pain
Inflammation
Objective parameters-
unit cutting time
|
Assessment will be done at baseline, followed by
weekly assessment until the fistula tract is
completely healed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters–
Itching
Burning sensation
Discharge
Pain
Inflammation
|
Upto 2 months after cut through of the fistula tract |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/08/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In this trial we are selecting patients of Bhagandara and dividing them into two
groups with 30 patients in each group. In 1st group, we will do intervention with standard Apamarga kshar sutra ligation of fistula tract and in 2nd group, we will do intervention with
Gunja kshar sutra ligation of fistula tract. Comparative study to be done on the basis of
assessment based on subjective and objective parameters. Subjective parameters includes Burning
sensation , Itching, Discharge, Pain and Inflammation and Objective parameters includes unit
cutting time |