FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077708 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The Management of a Chronic wound with the local cleaning with Apamarga Kshara Jala 
Scientific Title of Study   AN OPEN RANDOMISED CONTROL STUDY OF APAMARGA KSHARAJALA IN THE MANAGEMENT OF DUSTA VRANA 
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 Priyadarshini Vijay Hanje 
Designation  Assistant Professor Department of Shalyatantra 
Affiliation  Hon Shri Annasaheb Dange Ayurvedic Medical College Ashta Sangli 
Address  Hon Shri Annasaheb Dange Ayurvedic Medical College Ashta Sangli

Sangli
MAHARASHTRA
416301
India 
Phone  7899931108  
Fax    
Email  priyadarshinihanje1991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Shedage 
Designation  Professor Department of Shalyatantra 
Affiliation  L R P Ayu.Med .College,Hospital.P.G.Institute and Research centre,Islampur(Maharashtra) 
Address  L R P Ayu.Med .College,Hospital.P.G.Institute and Research centre,Islampur(Maharashtra)

Sangli
MAHARASHTRA
415409
India 
Phone  8888944733  
Fax    
Email  amit.shedage12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Shedage 
Designation  Professor Department of Shalyatantra 
Affiliation  L R P Ayu.Med .College,Hospital.P.G.Institute and Research centre,Islampur(Maharashtra) 
Address  L R P Ayu.Med .College,Hospital.P.G.Institute and Research centre,Islampur(Maharashtra)

Sangli
MAHARASHTRA
415409
India 
Phone  8888944733  
Fax    
Email  amit.shedage12@gmail.com  
 
Source of Monetary or Material Support  
Hon Shri Annasaheb Dange Ayurvedic Medical College Ashta 
LRP AYURVEDIC MEDICAL COLLEGE ISLAMPUR DIST SANGLI 
 
Primary Sponsor  
Name  Hon Shri Annasaheb Dange Ayurvedic Medical College Ashta 
Address  Department of Shalyatantra Hon Shri Annasaheb Dange Ayurvedic Medical College Ashta 
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 
Dr Priyadarshini Vijay Hanje  Hon Shri Annasaheb Dange Ayurvedic Medical College Ashta  Department of shalyatantra.Dhanvantari Hospital ,Shalyatantra OPD.
Sangli
MAHARASHTRA 		 7899931108

priyadarshinihanje1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hon. Shri Annasaheb Dange Ayurved Medical College Ashta  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-betadine solutionIn this group infected wound is washed with normal saline. Sterile gauze dipped in betardine solution is used to clean the dusta vrana A dry sterile gauze is used to bandage the dusta vrana. On the next day dressing is repeated.
2Intervention ArmDrugClassical(1) Medicine Name: APAMARGA KSHARAJALA, Reference: 8. A review on management of warts in Ayurveda. U .R.Sekhar Namburi, Omprakash, and G.BAPU, Route: Topical, Dosage Form: Kshara , Dose: 1(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Solution is prepared by mixing 10g of apamargakshara in 50 ml of distilled water
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having infected wound .
Wound size length not more than 5-5cm.
Depth not more than 1cm 
 
ExclusionCriteria 
Details  Malignantr ulcer.
Tubercular ulcer.
Patient suffering from HIV,HBsAg.
Patients on chemptheraphy,steroidotheraphy 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
All the subjective parameters pain,kandu,consistency of srava,wound floor,tenderness,gandha,wound area,healthy granulation tissue   3rd ,6rd,9th,12th,and 15th day  
 
Secondary Outcome  
Outcome  TimePoints 
Wound healing  15days 
 
Target Sample Size   Total Sample Size="218"
Sample Size from India="218" 
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 
Date of First Enrollment (India)   20/12/2024 
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="2"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  		 Its the need of hour to find out a Rational and Optimal healing compound for the wound management in a better way.Hence it is important to find out a single and effective formulation .That possesses both vranashodhana and vranaropana properties.Kshara therapy is an important therapy explained in Ayurveda.However Sushruta has indicatedkshara for shodhana and ropana ,chedana,lekhana properties. 
Close