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CTRI Number  CTRI/2024/09/074347 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of vidarikanda lepa in volunteers having suntan. 
Scientific Title of Study   A randomised controlled clinical study to compare varnya effect of vidarikanda(Pueraria tuberosa DC) lepa with yashtimadhu(Glycyrrhiza glabra Linn) lepa in suntan(darkening of skin). 
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 Vaishnavi Sanjayrao Talokar 
Designation  P.G. Scholar 
Affiliation  Tilak Ayurved Mahavidyalaya, Pune 
Address  Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9763373553  
Fax    
Email  vaishnavitalokar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asmita U Jadhav 
Designation  Associate Professor 
Affiliation  Tilak Ayurved Mahavidyalaya, Pune 
Address  Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9359772607  
Fax    
Email  asmita.niramaya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Asmita U Jadhav 
Designation  Associate Professor 
Affiliation  Tilak Ayurved Mahavidyalaya, Pune 
Address  Dravyaguna department, Tilak Ayurved Mahavidyalaya, Rasta peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9359772607  
Fax    
Email  asmita.niramaya@gmail.com  
 
Source of Monetary or Material Support  
Tilak Ayurved Mahavidyalaya, Rasta peth and Seth Tarachand Ramnath charitable Ayurved hospital, 583/2,Rasta peth,Pune 411011, Maharashtra, India 
 
Primary Sponsor  
Name  Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurved hospital 
Address  583/2,Rasta peth, Pune 411011, Maharashtra, India 
Type of Sponsor  Research institution and hospital 
 
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 Vaishnavi Sanjayrao Talokar  Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurved hospital  OPD no 27, 4 th floor, 583/2 Rasta peth, pune 411011, Maharashtra, India
Pune
MAHARASHTRA 		 9763373553

vaishnavitalokar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurved hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Skin colour change due to suntanning  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vidarikanda(Pueraria tuberosa), Reference: Bhavaprakash nighantu , Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 21 Days, Reference: Yes, Route: -water, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Yashtimadhu( Glycyrrhiza glabra Linn), Reference: Bhavaprakash nighantu , Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 21 Days, Reference: No, Route: NA, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  History of sun rays exposure Trackers and athletic after heavy exposure to sun rays
Not undergoing any skin treatment and cosmetic therapy from last 3 months.
 
 
ExclusionCriteria 
Details  Suntan due to any other reason Suntan along with other skin disease and allergic to cosmetic products. 
 
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 
Decrease in the discoloration  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Oil content and moisture content of skin will be maintained  21 days 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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/ Phase 4 
Date of First Enrollment (India)   15/10/2024 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vaishnavitalokar@gmail.com].

  6. For how long will this data be available start date provided 28-08-2024 and end date provided 21-08-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The study will be intervened by the treatment of Vidarikanda lepa and Yashtimadhu lepa to Group A and Group B respectively. The efficacy of the drug will be assessed on the basis of subjective criteria for statistical analysis. scoring will be designed according to the severity of the symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment, and after follow-up. The effect of treatment results will be assessed in regard to clinical signs and symptoms on the basis of a grading and scoring system. 
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