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CTRI Number  CTRI/2021/12/039014 [Registered on: 29/12/2021] Trial Registered Prospectively
Last Modified On: 02/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Validation Study for Testing Methods, Tests ]  
Study Design  Other 
Public Title of Study   An experimental standardization study for methods, tests, subjective assessments used to check safety and effectiveness of Hair Growth Products  
Scientific Title of Study   A Validation Study for Methods, Tests, Subjective Evaluations Carried Out in Safety and Efficacy Testing for Hair Growth Products  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NB210007-NB Version 01 Date 13Dec21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Medical Director Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  91-9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Medical Director Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj


GUJARAT
382421
India 
Phone  91-9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj

Gandhinagar
GUJARAT
382421
India 
Phone  91-9909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
NovoBliss Research Private Limited Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj, Gandhinagar - 382421, Gujarat 
 
Primary Sponsor  
Name  NovoBliss Research Private Limited 
Address  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj Gandhinagar 382421 Gujarat 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Maheshvari Patel  NovoBliss Research Private Limited  Office A 206 2nd Floor Shaligram Lakeview Business Complex Near Vaishnodevi Circle Khoraj
Gandhinagar
GUJARAT 		 91-79-48983895

maheshvari@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subject is in good general health as determined by the Investigator on the basis of medical history 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL - Not Applicable  NIL - Not Applicable 
Comparator Agent  NIL - Not Applicable  NIL - Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age: 18-65 years (both inclusive) at the time of consent.
2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3) Females of childbearing potential must have a self-reported negative urine pregnancy.
4)Subject is in good general health as determined by the Investigator on the basis of medical history.
5) Subject is willing and able to follow and allow study staff to perform study test methods.
6) Subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
7) Subject must be able to understand and provide written informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1) Subject have history of allergy to any ink.
2) Subject have participated any clinical research study related to hair care products.
3) Subject having history of diabetes
4) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
5) Subject having known history of any skin diseases including eczema, atopic dermatitis or active cancer. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The objective of this validation study is to evaluate the standardize the methods, procedural steps, validate the hair growth rate measurement, 60-s combing test, pull test, pluck test, subjective scoring of Hair quality appearance and scalp condition - evaluations techniques that are used during the conduct of clinical safety and efficacy studies for hair care product evaluation at/by NovoBliss Research on healthy adult human subjects  Day 01 and Day 04 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  None 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/01/2022 
Date of Study Completion (India) 12/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This is an In-house process validation study. 
This validation study will be carried out on/by study staff of the NovoBliss Research who is voluntarily wish to take part in this internal validation study. There are multiple hair evaluation techniques involved for testing hair growth products these testing methods for establishing documentary evidence demonstrate that standardised procedural steps, processes and methods carried out in testing for hair care safety and efficacy studies to maintain the desired level of compliance. 
It is very important that in addition to final testing and compliance of products during an actual clinical study, it is also assured that the processes will consistently produce consistent results. The consistent results are established in terms of specifications for the outcome of the process.  
 
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