FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087933 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of vatsnabhadi lepa in comparison with eusol in dushta vrana 
Scientific Title of Study   Randomised controlled trial to evaluate efficasy of vatsnabhadi lepa in comparison with eusol in dushta 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 Kalyani Anil Deshmukh  
Designation  PG scholar  
Affiliation  Mams Sumatibhai Shah Ayurved mahavidyalaya hadpsar  
Address  Opd no.4 Agadtantra department ground floor sane guruji arogya kendra Hadpsar pune

Pune
MAHARASHTRA
411028
India 
Phone  8554852673  
Fax    
Email  kavdeshmukh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manohar khankhane  
Designation  Head of department  
Affiliation  Mams Sumatibhai Shah Ayurved mahavidyalaya hadpsar Pune  
Address  Opd no. 4 Agadtantra department ground floor sane guruji arogya kendra Hadpsar pune

Pune
MAHARASHTRA
411028
India 
Phone  8888763651  
Fax    
Email  khankhanemanohar@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalyani Anil Deshmukh 
Designation  PG scholar  
Affiliation  Mams Sumatibhai Shah Ayurved mahavidyalaya hadpsar Pune  
Address  OPD no. 4 agadtantra department ground floor sane guruji arogya kendra Hadpsar pune

Pune
MAHARASHTRA
411028
India 
Phone  8554852673  
Fax    
Email  kavdeshmukh@gmail.com  
 
Source of Monetary or Material Support  
MAMS Sumatibhai Shah Ayurved College OPD no. 4 Agadtantra Department Ground Floor Sane guruji Arogya Kendra Hadapsar Pune-411028 Maharashtra India 
 
Primary Sponsor  
Name  Dr Kalyani Anil Deshmukh  
Address  O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune-411028 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 Kalyani Anil Deshmukh   Sane guruji arogya kendra Hadpsar pune   Opd no. 4 Agadtantra department Mams Sumatibhai Shah Ayurved mahavidyalaya hadpsar Pune
Pune
MAHARASHTRA 		 8554852673

kavdeshmukh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee MAMS Sumatibhai Shah Ayurved Mahavidyalaya And Sane Guruji Arogya Kendra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T889||Complication of surgical and medical care, unspecified. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-EusolAllopathic medicine
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having infected wound.
Wound size 1 × 1 cm to 8 × 8cm.
Infected wound due to trauma & accident with foul smell
and pus discharge.
Post- operative all infected wound.
Diabetic Mellitus 
 
ExclusionCriteria 
Details  Gangrenous wound.
Neo-plastic ulcer.
Burn, Arterial ulcer, Gout, Renal failure.
Liver failure.
Bed Sores.
Varicose ulcer.
HIV & Immuno-compromised patients 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Treatment will continue till signs of shudhavrana are seen 3 weeks  Treatment will continue till signs of shudhavrana are seen
3 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To observe the duration required for achieving Shuddha Avastha
To see the adverse effect of vatsnabhadi lepa dressing during the treatment 		 15 to 20 days 
 
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   Phase 3 
Date of First Enrollment (India)   20/06/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Infected wound is one of the major contributor to morbidity and mortality
World wise annually 2 million cases concern annually worldwide. Each year it is
to estimated that infected wound developed in 2%-5% of the 16 million
patients undergoing surgical procedure. In developing countries where
resources are scarce is problem is aggravated. In Vatsnabhadi lepa indivisually
all drug has been tested for their different properties but no previous study
has done for this formulation. This study plan to access the efficacy of
vatsnabhadi lepa in management of dushta vrana.
Among all the Mahavisha, Vatsanabha has its own importance. It is the only
Mahavisha that is still recognised and available. Compounds containing
Vatsanabha are enlisted as essential medications for Ayurveda dispensaries
operated under centrally supported programmes of the government of India
 
Close