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CTRI Number  CTRI/2023/08/057002 [Registered on: 28/08/2023] Trial Registered Prospectively
Last Modified On: 26/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Palash ksharsutra and Svarnakshiryadi taila on Fistula in ano 
Scientific Title of Study   A clinical study to evaluate the efficacy of Palash ksharsutra and Svarnakshriyadi taila in the management of Bhagandara W.S.R to Fistula in ano 
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 Manju 
Designation  PG Scholar 
Affiliation  Madan Mohan Malaviya Government Ayurved College Udaipur 
Address  PG Scholar Shalya tantra Department Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001

Udaipur
RAJASTHAN
313001
India 
Phone  8619082117  
Fax    
Email  minu15pilania@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Dixit 
Designation  Professor and HOD 
Affiliation  Madan Mohan Malaviya Government Ayurved College Udaipur 
Address  Professor and HOD Shalya tantra Department Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001

Udaipur
RAJASTHAN
313001
India 
Phone  9414245459  
Fax    
Email  prof.maheshdixit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahesh Dixit 
Designation  Professor and HOD 
Affiliation  Madan Mohan Malaviya Government Ayurved College Udaipur 
Address  Professor and HOD Shalya tantra Department Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001


RAJASTHAN
313001
India 
Phone  9414245459  
Fax    
Email  prof.maheshdixit@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malaviya Government Ayurved college Udaipur 
 
Primary Sponsor  
Name  Madan Mohan Malaviya Government Ayurved college Udaipur 
Address  Madan Mohan Malaviya Government Ayurved college Udaipur PIN 313001 
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 Manju  Madan Mohan Malaviya Government Ayurved College Udaipur  OPD No 1 PG Department of Shalya tantra Associated group of hospitals Madan Mohan Malaviya Government Ayurved College Udaipur PIN 313001
Udaipur
RAJASTHAN 		 8619082117

minu15pilania@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,M.M.M. Govt.Ayurved College,Udaipur  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
1Comparator ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushrutha samhitha, Procedure details: ksharasutra will be applied on fistula tract and will be changed after every 7 days for the duration of 2 month.)
2Intervention ArmProcedure-kShArasUtra, क्षारसूत्र (Procedure Reference: Sushrutha samhitha, Procedure details: ksharasutra will be applied on fistula tract and will be changed every 7 days for the duration of 2 months)
(1) Medicine Name: Svarnakshiryadi taila, Reference: Sushrutha samhitha, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 2 Months
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)fistula tract upto 1-7 cm
2)patients suffering from signs and symptoms of bhagandara 
 
ExclusionCriteria 
Details  1)Age below 16 yrs and above 60 yrs
2)high anal fistula having tract more than 7 cm
3)malignancy,HIV and uncontrolled hypertension 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1)symptoms like pain,discharge & itching will be analysed  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)cutting rate of tract will be analysed  1 week,2 weeks,3 weeks & 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)   01/10/2023 
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="2"
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   This is parallel group study to evaluate the efficacy of palash ksharasutra and svarnakshiryadi taila in the management of fistula in ano.In this study group A,15 patients will be administered with palash ksharasutra  which will be changed in the interval of 7 days.And group B,15 patients will be administered with palash ksharasutra along with svarnakshiryadi taila,10 ml,od for the duration of 2 months. 
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