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CTRI Number  CTRI/2023/08/056136 [Registered on: 04/08/2023] Trial Registered Prospectively
Last Modified On: 03/08/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Valmika Face Pack 
Scientific Title of Study   Effect Of Valmikadi Mruttika In the management of Acne Vulgaris 
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 Nimesh Sangode 
Designation  Associate Professor 
Affiliation  Parul Institute Of Ayurved And Research 
Address  Department Of Rachna Sharir Parul Institute Of Ayurved And Research Ishwarpura

Vadodara
GUJARAT
391760
India 
Phone  9890752989  
Fax    
Email  nimeshsangode@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nimesh Sangode 
Designation  Associate Professor 
Affiliation  Parul Institute Of Ayurved And Research 
Address  Department Of Rachana Sharir Parul Institute Of Ayurved And Research Ishwarpura

Vadodara
GUJARAT
391760
India 
Phone  9890752989  
Fax    
Email  nimeshsangode@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nimesh Sangode 
Designation  Associate Professor 
Affiliation  Parul Institute Of Ayurved And Research 
Address  Department Of Rachana Sharir Parul Institute Of Ayurved And Research Ishwarpura

Vadodara
GUJARAT
391760
India 
Phone  9890752989  
Fax    
Email  nimeshsangode@gmail.com  
 
Source of Monetary or Material Support  
tEACHING PHARMACY, PARUL INSTITUTE OF AYURVED AND RESAERCH, ISWARAPURA, LIMDA, WAGHODIA VADODARA  
 
Primary Sponsor  
Name  Parul University 
Address  Parul University Po Limbda Waghodia Vadodara 
Type of Sponsor  Other [State Private University] 
 
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 Nimesh Sangode  Khemdas Ayurved Hospital  OPD Of Kayachikitsa Department Khemdas Ayurved Hospital Ishwarpura Waghodia Vadodara
Vadodara
GUJARAT 		 9890752989

nimeshsangode@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC PIAR HR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Valmika mruttikadi lepa, Reference: Sushrut Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Cause Due To Hormonal And Lifestyle Changes
Skin Texture Normal To Oily 
 
ExclusionCriteria 
Details  Age Group Above 30 Years
Cause Iatrogenic
Skin Texture Dry 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Get Rid Of Acne   15 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence Of Acne Will Be Reduced  15 Days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   17/08/2023 
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="0"
Days="15" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [nimeshsangode@gmail.com].

  6. For how long will this data be available start date provided 26-10-2023 and end date provided 01-05-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   To  see the effect of our  valmikadi mrittika lepa on the subjects suffering from acne vulgaris  in the due course of 15 days  
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