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CTRI Number  CTRI/2025/01/079453 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
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 Clinical Trial To Study The Effect Of Ashwagandhadi Lepa in The Management Of Ghrustha Vrana With Special Reference To Abrased Wound  
Scientific Title of Study   Randomised Controlled Clinical Trial to Evaluate the Efficacy Of Ashwagandhadi Lepa in the Management of Ghrishta Vrana with special reference to Abrased Wound. 
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 Vaibhav Vasantrao Nalawade  
Designation  PG Scholar 
Affiliation  LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur  
Address  LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangli

Sangli
MAHARASHTRA
415409
India 
Phone  9545998821  
Fax    
Email  vaibhavnalawade143@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Ramachandra Shedge  
Designation  HOD Professor in Shalyatantra Department  
Affiliation  LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur  
Address  LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Reserch Centre Islampur Department Of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangli

Sangli
MAHARASHTRA
415409
India 
Phone  8888944733  
Fax    
Email  amit.shedage12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaibhav Vasantrao Nalawade  
Designation  PG Scholar 
Affiliation  LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur  
Address  LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Reserch Centre Islampur Department Of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangli

Sangli
MAHARASHTRA
415409
India 
Phone  9545998821  
Fax    
Email  vaibhavnalawade143@gmail.com  
 
Source of Monetary or Material Support  
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Urun Islampur Tal Walwa Dist Sangli 415409 Maharashtra India 
 
Primary Sponsor  
Name  Dr Vaibhav Vasantrao Nalawade  
Address  Department Of Shalyatantra LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre urun Islampur Tal Walwa Dist Sangli 415409 Maharashtra India 
Type of Sponsor  Other [Self] 
 
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 Vaibhav Vasantrao Nalawade  LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Reserch Centre  Department Of Shalyatantra Division No 1 Room No 1 LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Reserch Centre Islampur Department Of Shalyatantra Tal Walwa Dist Sangli Maharashtra 415409 India
Sangli
MAHARASHTRA 		 9545998821

vaibhavnalawade143@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Reserch Centre Islampur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T149||Unspecified injury. Ayurveda Condition: GHRUSHTAH, (2) ICD-10 Condition:T149||Unspecified injury. Ayurveda Condition: GHRUSHTAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ashwagandhadi lepa, Reference: Bhaishajya ratnavali adhaya number 47 , shloka number 46, Route: Topical, Dosage Form: Lepa Churna, Dose: 40(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -local application of lepa for 0th, 1st,2nd , 3rd,4th,5th,6th day
2Comparator Arm (Non Ayurveda)-Betadine ointment Betatadine ointment for local application for group B on the day of 0th, 1st,2nd ,3rd,4th,5th,6th
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients having only sign and symptoms of Ghrishta vrana (Abrasion).
2) Patients can vary in age from 15 to 60 years.
3) Patients irrespective of sex, religion, socio-economic.
4) wounds that occur within 6 hours after an injury.
5) Dimension of lacerated wound upto 8cm × 4cm × 0.5mm.
(Length × width x depth). 
 
ExclusionCriteria 
Details  1)Diagnosed Patients of known case of systemic illeness Diabetic wounds,
Gangrenous wounds.
2)Burn wound, Bedsore.
3)Patients having bleeding disorder.
4)patients having immune compressive disease like HbsAg , AIDS or HIV syndrome, DM, Hepatitis B., TB.
5) patient with ploytrauma will be excluded.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Assess the Efficacy of Ashwagandhadi Lepa in the Management of Ghrishta
Vrana with special reference to Abrased Wound.  		 Application Of Lepa on 0th , 1st, 2nd ,3rd , 4th , 5th, 6th day 
 
Secondary Outcome  
Outcome  TimePoints 
1) To Study Ghrishta vrana in details as per Ayurvedic concept.
2) To study wound in details according to modern aspect.
3) To see the effect on the rate of healing of the wound.
4) To provide safe,affordable and effective Ashwagandhadi lepa in Ghrishta
vrana ropan chikistha .  		 Application Of Lepa on 0th , 1st, 2nd ,3rd , 4th , 5th, 6th days
follow up 9th, 12th,15th day 
 
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)   04/02/2025 
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 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   Objective – To assess the efficacy of Ashwagandhadi lepa in the management of Ghrishta vrana with special reference to abrased wound. 
Group A (Trial Group) - 40 patients (excluding dropouts) NS -  (for cleaning) Ashwagandhadi lepa 
Group B ( Control Group) - 40 patients (excluding dropouts) - NS(for cleaning) Betadine ointment
Management of ghrishta vrana generally involve Ropana karama followed by sterile dressing ,where as Ashwagandhadi lepa fullfill the properties of vrana ropan ,veadnashamak, shothhar ,raktstambhak which is importance for wound healing . 
SAMPLING TECHNIQUE – Simple Random Sampling Technique. 80 diagnosed Ghrishta vrana patients will be present at the OPD and IPD fulfilled the inclusive and exclusive criteria will be selected by computer generated random number method.
Application Of Lepa on - 0th , 1st, 2nd , 3rd , 4th , 5th , 6th, days 
Follow Up - 9th ,12th, 15th Day 
Assessment Criteria - The Study will be strictly based on Assessment of Subjective Parameter by the Grading them.
OBSERVATION TABLE - Observations & results will be noted during & at the end of study, Page | 22 statistical analysis, discussion will be done & conclusion will be drawn accordingly. Examination of signs and symptoms of Ghrishta vrana will be noted. Photograph will be taken before and after treatment in case of special Interest. 
DISCUSSION:- Discussion will be made after statistical analysis and according to the result observed at the end of treatment.
RESULTS & CONCLUSION:- Conclusion will be drawn on the basis of statistical analysis with overall assessment tabulation and graphic representation of data. 
SUMMARY:- All clinical work will be summarized step by step.
 
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