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CTRI Number  CTRI/2023/03/051012 [Registered on: 23/03/2023] Trial Registered Prospectively
Last Modified On: 23/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Ksharsutra ligation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to evaluate efficacy of Bibhitak Ksharsutra ligation in the management of Bhagandara with special reference to Low level fistula in ano 
Scientific Title of Study   Clinical study of efficacy of Bibhitak Ksharsutra ligation in the management of Bhagandara with special reference to Low level fistula in ano 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kailash Chand 
Designation  PG Scholar 
Affiliation  Government Ayurved college and Hospital, Vazirabad, Nanded  
Address  Department of Shalyatantra, Government Ayurved college, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  8058852860  
Fax    
Email  kailashpersonal1508@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra H Amilkanthwar 
Designation  Associate Professor  
Affiliation  Government Ayurved college and Hospital, Vazirabad, Nanded  
Address  Department of Shalyatantra, Government Ayurved college, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra H Amilkanthwar 
Designation  Associate Professor  
Affiliation  Government Ayurved college and Hospital, Vazirabad, Nanded  
Address  Department of Shalyatantra, Government Ayurved college, Vazirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College, Vazirabad, Nanded 
 
Primary Sponsor  
Name  Dr. Kailash Chand 
Address  Department of Shalyatantra, Government Ayurved College, Vazirabad, Nanded  
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 Kailash Chand   Government Ayurved Hospital Nanded  Department of Shalyatantra Hospital building OPD No.6 & 7 IPD Ward No.51 & 63
Nanded
MAHARASHTRA 		 8058852860

kailashpersonal1508@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   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: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushrut Samhita, Procedure details: Bibhitak ksharsutra ligation every week for maximum upto 8 weeks)
2Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushrut Samhita, Procedure details: Apamarga Ksharsutra ligation every week for maximum upto 8 weeks)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed as a case of fistula in ano viz. low level Fistula in ano with one/ two external openings.
2. Patient of either sex will be selected randomly for the study
3. Patient of age group between 18 – 60 years.
4. The fistulous tract length having 2-8 cm.  
 
ExclusionCriteria 
Details  1. Carcinoma of rectum.
2. Pregnancy.
3. Patient suffering from any systemic disease e.g. uncontrolled HTN, DM, TB, CVS, HIV +ve, any acute systemic illness.
4. Patients having other perianal /Rectal diseases
5. Patients with Multiple fistula, Patients with High anal fistula
6. Acute and chronic ulcerative colitis
7. Other major disease related anorectal.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Complete cutting of fistulous tract  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Complete cutting of fistulous tract
2. Decreased pain
3. Decreased discharge  		 8 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)   30/03/2023 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is prospective, randomized, open labelled, controlled clinical study of efficacy of Bibhitak Ksharsutra ligation with assessment  on every week for maximum upto 8 weeks in the management of Bhagandara with special reference to low level fistula in ano. This study is conducted as PG course at single center. The primary outcome is to study efficacy of Bibhitak Ksharsutra ligation in the management of Bhagandara with special reference to low level fistula in ano. 
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