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CTRI Number  CTRI/2022/01/039510 [Registered on: 18/01/2022] Trial Registered Prospectively
Last Modified On: 14/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of vranashodhak pralep in Dushtavrana (infected wound)  
Scientific Title of Study   Open randomised control clinical trial of efficacy of vranashodhak pralep in dushtavrana 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prashant Dagadu Date 
Designation  Professor 
Affiliation  Hon Shri Annasaheb Dange Ayurved Medical college post Graduate and Research center ,Ashta 
Address  Hon Shri Annasaheb Dange Ayurved Medical college Post Graduate And Research Centre Ashta Tal Walwa Dist Sangli
Hon Shri Annasaheb Dange Ayurved Medical college Post Graduate And Research Centre Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India 
Phone  9822706975  
Fax    
Email  drdateprashant@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prashant Dagadu Date 
Designation  Guide 
Affiliation  Annasaheb Dange AYurved Medical college 
Address  Hon Shree Annasaheb Dange AYurved Medical college And Post Graduate And Research Centre Ashta Tal : Walwa Dist : Sangli
Ashta Tal : Walwa Dist : Sangli
Sangli
MAHARASHTRA
416301
India 
Phone  9822706975  
Fax    
Email  drdateprashant@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prashant Dagadu Date 
Designation  Guide 
Affiliation  Annasaheb Dange AYurved Medical college 
Address  Hon Shree Annasaheb Dange AYurved Medical college And Post Graduate And Research Centre Ashta Tal : Walwa Dist : Sangli
Ashta Tal : Walwa Dist : Sangli

MAHARASHTRA
416301
India 
Phone  9822706975  
Fax    
Email  drdateprashant@gmail.com  
 
Source of Monetary or Material Support  
Hon. shri annasaheb dange Ayurved medical college ashta tal- walwa dist- sangli pin code- 416301 
 
Primary Sponsor  
Name  Hon Shri Annasaheb Dange Ayurvedic Medical college Post Graduate and Research Center Ashta 
Address  Hon Shri Annasaheb Dange Ayurved Medical College post graduate And Reaserch Centre Ashta tal walwa dist sangli 
Type of Sponsor  Private 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 
Gajanan Jadhav  Hon Shree Annasaheb Dange AYurved Medical college And Post Graduate And Research Centre Ashta   Hon Shree Annasaheb Dange AYurved Medical college And Post Graduate And Research Centre Ashta shalyatantra opd no.02 Tal : Walwa Dist : Sangli pincode 416301
Sangli
MAHARASHTRA 		 9511630672

gajananjadhav164@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: Infected wound patients, (2) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: Infected wound ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa (Procedure Reference: Vrana shodak lepa in manegement of Dushta व्रणशोधक प्रले प:-(trial group):- तिलकल् क: सलवणो द्वे हरिद्रे तिवृत्तघृिम मधुकं तिंबपिाति प्रले पो व्रणशोधि: ll च. चच. २५/८५, Procedure details: व्रणशोधक प्रलेप:- According to charak , तिलकल् क: सलवणो द्वे हरिद्रे तिवृत्तघृिम मधुकं तिंबपिाति प्रले पो व्रणशोधि: ll c.chi. २५/८५ Lavan wiil be added til kalka,haridra,daruharidra,nishoth,mulethi,nimba patra will be grinded to make a paste like consistency then add ghruta to it to apply this lepa on d)
(1) Medicine Name: Vranashodak lepa, Reference: Charak Chikitsa adhya 25/85, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  dushtavrana,infected ulcer,post operative abscess wound,diabetic wound non healing wound 
 
ExclusionCriteria 
Details  tuberculous ulcer, malignant ulcer,patients with systemic disorder 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of Vranashodhak pralep in dushtavrana.pain dischrge smell   28 days  
 
Secondary Outcome  
Outcome  TimePoints 
To review of Dushtavrana  4weeks 
 
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   N/A 
Date of First Enrollment (India)   23/01/2022 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   I am Gajanan Subhashraob Jadhav PG scholar Shalyatantra trying to evaluate the efficacy of Vranashodhak Praelp in Dushtvrana.
During this trial trying to evaluate the untoward effect of Vranashodhak Pralep in Dushtvrana .
as there is no previous work done on Vranashodhak Pralep.
So emphasis will be made to find out easy,cost effective method to control Dushtvrana with no side effects.
 
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