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CTRI Number  CTRI/2022/02/040533 [Registered on: 23/02/2022] Trial Registered Prospectively
Last Modified On: 22/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   “Kshsarsutra Chikitsha In The Management Of Bhagandra(Fistula-In-Ano)” 
Scientific Title of Study   “A Clinical Evaluation Of Ksharasutra Prepared By Using Sushrutokt Kshara In Comparision Of Apamarga Ksharasutra In The Management Of Bhagandara (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 Lokesh yadav 
Designation  Ph.D. Scholar 
Affiliation  Shri Krishana Ayush University Kurukshetra(Haryana)  
Address  Room no.103, First floor Department of Shalya Tantra Shri Krishana Ayush University Kurukshetra(Haryana)
Room no.103, First floor Department of Shalya Tantra Shri Krishana Ayush University Kurukshetra(Haryana)
Kurukshetra
HARYANA
136118
India 
Phone  9461040988  
Fax    
Email  lokeshyadav92.ly@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shriniwas Gujjarwar  
Designation  Professor & Head,  
Affiliation  Shri Krishana Ayush University Kurukshetra(Haryana)  
Address  Room no.103,first floor Department of Shalya Tantra Shri Krishana Ayush University Kurukshetra(Haryana)
Room no.103,first floor Department of Shalya Tantra Shri Krishana Ayush University Kurukshetra(Haryana)
Kurukshetra
HARYANA
136118
India 
Phone  9729092181  
Fax    
Email  ayurvedgoa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Lokesh yadav 
Designation  Ph.D. scholar  
Affiliation  Shri Krishana Ayush University Kurukshetra(Haryana)  
Address  Room no.103,first floor Department of Shalya Tantra Shri Krishana Ayush University Kurukshetra(Haryana)
Room no.103,first floor Department of Shalya Tantra Shri Krishana Ayush University Kurukshetra(Haryana)
Kurukshetra
HARYANA
136118
India 
Phone  9461040988  
Fax    
Email  lokeshyadav92.ly@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalya Tantra Shri Krishana Ayush University Kurukshetra(Haryana)  
 
Primary Sponsor  
Name  Department of Shalya Tantra SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRAHARYANA  
Address  Shri Krishna Ayush University,Umri Road, Sector 8,Kurukshetra, Haryana – 136118 
Type of Sponsor  Government medical college 
 
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 lokesh yadav  MLR ayurveda college and Hospital   Room no.16, shalya tantra opd, RK gupta marg charkhi dadri haryana 127306
Bhiwani
HARYANA 		 9461040988

lokeshyadav92.ly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Shri Krishna Ayush University,Kurukshetra, Haryana   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: BAGANDARAH, (2) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: BAGANDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Chapter 17 verse 30,31,32(Visarpanadistanaroga chikitsa ), Procedure details: Group A (Trial Group) – (50 Patients) This group will be treated with ksharasutra prepared by using sushrutokt kshara.Kshara sutra changes after every 7 days till complete healing of fistulous tract (approx.3 months ) as per registered Groups.)
2Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Chapter 17 verse 30,31,32(Visarpanadistanaroga chikitsa ), Procedure details: Group B (Control group) – (50 Patients) This group will be treated with standard Apamarga Ksharasutra. Kshara sutra changes after every 7 days till complete healing of fistulous tract (approx.3 months ) as per registered Groups.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of Bhagandara from 20 - 60 Years age group, irrespective of sex and economic status.
2.No major systemic disease involved.
3.Patients who have signs and symptoms of Bhagandara (Fistula-in-ano) like pidika, ruja, srava, kandu etc.
4.Patients who is agreed to sign the consent form. 
 
ExclusionCriteria 
Details  1.Patients belongs to less than 20 years and greater than 60 years of Age group.
2.Patient with known hypersensitivity to any of the components of the formulation.
3.High level fistula having internal opening in rectum or above anorectal ring.
4.Bhagandara (Fistula-in-ano) associated with one or more of the following conditions:-
a. Supra levator fistula in ano
b. Ulcerative Colitis
c. Uncontrolled Hypertension
d. Uncontrolled Diabetes Mellitus
e. Venereal diseases
f. HIV and Hepatitis B& C Patients.
g.CA rectum
h. Crohn’s disease
i.Fistula other than ano-rectal area.
j.All other secondary Fistula-in-ano. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Pain 2.Tenderness 3.Tenderness
4.Itching 		 All Parameters Assessment will be done in every 7 days till complete healing of fistulous tract (Approx. 3 month). 
 
Secondary Outcome  
Outcome  TimePoints 
5.Pus discharge 6. Unit healing time (U.H.T.)   All Parameters Assessment will be done in every 7 days till complete healing of fistulous tract (Approx. 3 month). 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 4 
Date of First Enrollment (India)   28/02/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A computer generated randomized clinical trial Entitled with  â€œA Clinical Evaluation Of Ksharasutra Prepared By Using Sushrutokt Kshara In Comparision Of Apamarga Ksharasutra In The Management Of Bhagandara (Fistula-In-Ano)” contains 2 groups with 50 patients in each group. Group A patients will be treated with Ksharsutra prepared by using Sushrutokt Kshara and group B by standard Apamarga Ksharsutra.Ksharasutra changes after every 7 days till complete healing of fistulous tract (approx.3 months ) as per registered Groups.All the patients registered for the study will be followed up on the weekly basis till complete healing of fistulous tract(approx.3 months ),then patients will be followed up every month for further six months.Criteria of assessment parameters are Pain(VAS Grading) Tenderness Burning sensation Itching Pus Discharge Unit HealingTime (UHT) All Parameters Assessment will be done in every 7 days till complete healing of fistulous tract (Approx. 3 month).    

 
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