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CTRI Number  CTRI/2022/08/044898 [Registered on: 24/08/2022] Trial Registered Prospectively
Last Modified On: 09/02/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the skin care product (Tejasvi emulsion) on healthy volunteers for rejuvenated, plump & radiant skin makes the skin soft, supple, and nourished 
Scientific Title of Study   A single centre, prospective dermatological study to evaluate the parameters on skin like rejuvenated, plump & radiant skin, makes the skin soft, supple, nourishes with skin care formulations (Tejasvi emulsion) in healthy volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MVS/CPS/12/2022, Version No.: 1.0; Dated: 13 May 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Esha Roy 
Designation  Principal Investigator (Dermatologist) 
Affiliation  Qaaf Healthcare International  
Address  Clinical Division, A-62,Basement Room No. B01
DDA Shed Okhla Industrial Area, Phase II
South
DELHI
110020
India 
Phone  9254425442   
Fax    
Email  dresharoy5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Nishant Singh  
Designation  Deputy Manager Regulatory Affairs  
Affiliation  Mountain Valley Springs India Pvt. Ltd.  
Address  B12, Block B
Sector 3, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  08860800289   
Fax    
Email  nishant.singh@forestessentialsindia.com  
 
Details of Contact Person
Public Query  
Name  Mr Nishant Singh  
Designation  Deputy Manager Regulatory Affairs  
Affiliation  Mountain Valley Springs India Pvt. Ltd.  
Address  B12, Block B
Sector 3, Noida

UTTAR PRADESH
201301
India 
Phone  08860800289   
Fax    
Email  nishant.singh@forestessentialsindia.com  
 
Source of Monetary or Material Support  
Mountain Valley Springs India Pvt. Ltd.  
 
Primary Sponsor  
Name  Mountain Valley Springs India Pvt Ltd  
Address  B12, Block B Sector 3, Noida Gautam Buddha Nagar UTTAR PRADESH 201301 India  
Type of Sponsor  Other [Cosmetic company] 
 
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 Esha Roy  Qaaf Healthcare International   Clinical division, A-62,Basement Room No. B01, DDA Shed, Okhla Industrial Area, Phase II
South
DELHI 		 9254425442

dresharoy5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Society for Research Welfare   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The objective of this study is to evaluate the Dermatological efficacy of Tejasvi Emulsion on healthy volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Tejasvi Emulsion , Reference: NA, Route: Topical, Dosage Form: Arka, Dose: 5(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Healthy subjects (no infectious and evaluative pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up)

Indian Male/Female subjects.

Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar etc)

Between 20 to 65 years of age, with normal skin condition.

Written informed consent signed by the subject in line with applicable regulation of country.
 
 
ExclusionCriteria 
Details  Having refused to give her consent by not signing the consent form.

Taking part in another study liable to interfere with this study.

Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis).
Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.

Having cutaneous hypersensitivity.

Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluation will include assessment of local adverse events of redness, itching, rashes and burning sensations and any other local side effect and will be categorized non serious (based on severity grades, patterns, and causality) and serious adverse events. There will be two types of assessment, subject self-assessment and dermatological evaluation by study investigator.
on a clinical examination.

Parameters:

1. Redness

2. Dryness

3. Itching

4. Irritation

5. Burning sensation on skin.
The evaluation will be performed using the following scale: 0- None, 1- Slight, 2- Moderate and 3-Severe 		 Subject Assessment will be done at 30 minutes, 20 days and 40 days after test product application  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/09/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

It is a single center, prospective study to evaluate efficacy and safety of skin care formulations (TEJASVI EMULSION) in healthy volunteers. This study will be conducted in compliance with applicable national regulations for post marketing requirement of cosmetic products with the aim of identifying or quantifying safety hazards relating to an authorized cosmetic product and is aligned with various guidelines and recommendations for good pharmacovigilance practices for cosmetic products.

This study will also be conducted according to the principles of the declaration of Helsinki, GCP guidelines, and all applicable national regulations for cosmetic trials. Subjects will be invited to voluntarily participate in the study and no study procedure will be conducted on any subject prior to written informed consent for the study.

 
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