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CTRI Number  CTRI/2023/04/052029 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 26/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A trial is to see durvadi ghrita and karanjadi ghrita are effective or noneffective in an infected wound 
Scientific Title of Study   Randomized open comparative clinical study to assess the effect of durvadi ghrita and karanjadi ghrita as ropan in management dhushta Vrana 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aniket Anil Bobade  
Designation  pg scholer 
Affiliation  Yashwant ayurvedic medical college and post graduation training centre kolhapur 
Address  shalyatantra department last floor Yashwant ayurvedic medical college and postgraduation training center Kolhapur
shalyatantra department last floor Yashwant ayurvedic medical college and postgraduation training center Kolhapur
Kolhapur
MAHARASHTRA
416114
India 
Phone  8862040722  
Fax    
Email  aniketbobade09422@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  dr suyog patil  
Designation  associate professor, yashwant ayurvedic college and post graduation research center kodoli kolhapur 
Affiliation  Yashwant ayurvedic medical college and post graduation training centre kolhapur 
Address  shalyatantra department last floor Yashwant ayurvedic medical college and postgraduation training center Kolhapur
shalyatantra department last floor Yashwant ayurvedic medical college and postgraduation training center Kolhapur
Kolhapur
MAHARASHTRA
416114
India 
Phone  9823190222  
Fax    
Email  drsuyog0222@gmail.com  
 
Details of Contact Person
Public Query  
Name  aniket anil bobade  
Designation  pg scholar  
Affiliation  Yashwant ayurvedic medical college and post graduation training centre kolhapur 
Address  shalyatantra department last floor Yashwant ayurvedic medical college and postgraduation training center Kolhapur
shalyatantra department last floor Yashwant ayurvedic medical college and postgraduation training center Kolhapur
Kolhapur
MAHARASHTRA
416114
India 
Phone  8862040722  
Fax    
Email  aniketbobade09422@gmail.com  
 
Source of Monetary or Material Support  
shalyatantra department yashwant ayurvedic college and hospital kodoli tal panhala dist-kolhapur 416114 
 
Primary Sponsor  
Name  Aniket Anil Bobade 
Address  Yashwant ayurvedic college and PG training centre kolhapur 416114 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Aniket Anil Bobade  Yashwant ayurvedic college and research centre kolhapur 416114 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aniket Anil Bobade  yashwant ayurvedic medical college and post graduation training centre,kolhapur  shalyatantra department last floor Yashwant ayurvedic medical college and postgraduation training center Kolhapur
Kolhapur
MAHARASHTRA 		 8862040722

aniketbobade09422@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee yashwant ayurved college PGT &RC kodoli kolhapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar samhita, Procedure details: Local application of durvadi ghrita)
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: sharandhar samhita, Procedure details: local application of karanjadi ghrita on dushtana)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Irrespective of gender economic class caste religion
diabetic in control or fair control 
 
ExclusionCriteria 
Details  Tubercular ulcers
venous ulcers
malignant ulcers 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain smell burning itching swelling   for 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
size discharge tenderness granulation  15 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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/ Phase 3 
Date of First Enrollment (India)   05/05/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The assessment will be done based on observations score depending upon the change in the sign and symptoms of the Vrana (infected wound) allong with the healing of the wound for assessing the effect of the durvadi ghrita and karanjadi ghrita. 
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