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CTRI Number  CTRI/2025/09/095136 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of sushrutokta manjisthadi tail on vrana ropan 
Scientific Title of Study   A clinical study of sushrutokta manjisthadi tail on vrana ropan 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raju Kumar  
Designation  Post Graduate Scholar  
Affiliation  S.G.M.P.G. Ayurvedic Medical College and Hospital, Saheri, Ghazipur, UP-233302 
Address  Dept of Shalya Tantra, S.G.M.P.G. Ayurvedic Medical College and Hospital, Saheri, Ghazipur, UP-233302

Ghazipur
UTTAR PRADESH
233302
India 
Phone  9006638030  
Fax    
Email  rajubams1298@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Surendra Kumar Mishra  
Designation  Prof and H.O.D 
Affiliation  S.G.M.P.G. Ayurvedic Medical College and Hospital, Saheri, Ghazipur, UP-233302 
Address  Dept of Shalya Tantra, S.G.M.P.G. Ayurvedic Medical College and Hospital, Saheri, Ghazipur, UP-233302

Ghazipur
UTTAR PRADESH
233302
India 
Phone  9415970999  
Fax    
Email  Indrajeetsgmgzp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raju Kumar  
Designation  Post Graduate Scholar  
Affiliation  S.G.M.P.G. Ayurvedic Medical College and Hospital, Saheri, Ghazipur, UP-233302 
Address  Dept of Shalya Tantra, S.G.M.P.G. Ayurvedic Medical College and Hospital, Saheri, Ghazipur, UP-233302

Ghazipur
UTTAR PRADESH
233302
India 
Phone  9006638030  
Fax    
Email  rajubams1298@gmail.com  
 
Source of Monetary or Material Support  
Sgmpg ayurvedic medical college and hospital saheri Ghazipur up 233302 
 
Primary Sponsor  
Name  Sgmpg ayurvedic medical college and hospital  
Address  Sgmpg ayurvedic medical college and hospital saheri Ghazipur up233302 
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 Raju Kumar  S.G.M.P.G. Ayurvedic Medical College and Hospital  Department of Shalya Tantra, S.G.M.P.G. Ayurvedic Medical College and Hospital, Saheri, Ghazipur, UP-233302
Ghazipur
UTTAR PRADESH 		 8709604066

rajubams1298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee( Sgmpg ayurvedic medical college and hospital saheri Ghazipur up 233302)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Susruta Samhita, Sutrasthana 46/323–326, Procedure details: Group A - Locally apply of Manjisthadi Tail on Vrana for Vrana Ropan. Group B - Locally Apply Placebo(Antiseptic Lotion) on Vrana for Vrana Ropan. )
(1) Medicine Name: Manjisthadi Tail, Reference: Susruta Samhita, Chikitsasthana 13 Adhyay, Route: Topical, Dosage Form: Taila, Dose: 00(NA), Frequency: od, Duration: 45 Days
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  -On the basis of sign & symptoms seen of “Vrana”.
-The age group of patient taken between 15-60 years. 
 
ExclusionCriteria 
Details  Patient associated with chronic disease like AIDS, Cancer, Hepatitis B, T.B, Cardiac Complications,
Diabetic, Pregnant or Lactating women etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of wound healing.
Time taken for complete epithelialization(Vrna Ropan). 		 Baseline (Day 0), Day 7, Day 14, Day 21, and Day 28 (or until complete healing, whichever is earlier). 
 
Secondary Outcome  
Outcome  TimePoints 
1.Pain reduction.
2. Reduction in local inflammation (erythema, edema, tenderness).
3. Quality of granulation tissue formation (healthy, red, moist vs. unhealthy).
4. Rate of discharge/exudate reduction (amount & nature).
5. Scar quality and cosmetic appearance (assessed by Patient and Observer Scar Assessment Scale – POSAS, or Ayurvedic parameter Vrna Ropan).
6. Time taken for relief from associated symptoms (itching, burning, foul smell).
 		 Baseline (Day 0), Day 7, Day 14, Day 21, and Day 28 (or until complete healing, whichever is earlier). 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   03/10/2025 
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="0"
Months="3"
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   The present clinical trial study is designed to assess the evaluate the efficacy of Manjisthdi Tail in the managment of Vrana w.s.r to vrana ropan. In ayurveda Susruta has described Manjisthadi formulations as possessing ropan, sodhana and vrana ropan properties so this research aims to provide scientific validation of a classical Ayurvedic formulation in wound managment. 
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