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CTRI Number  CTRI/2024/03/063657 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [hair oil]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to check hair growth benefits 
Scientific Title of Study   To evaluate the safety and efficacy of the test products in comparison to baseline in improving hair growth rate and reducing hair fall among healthy subjects 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HAIR/MAHS/2024-01, version 1.0 dated 22 Feb 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research 
Address  Room no. 1, Second floor Hair department 327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research 
Address  Room no. 1, Second floor Hair department 327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@msclinical.com  
 
Details of Contact Person
Public Query  
Name  Dr Mukesh Ramnane 
Designation  Principal Investigator 
Affiliation  MS Clinical Research 
Address  Room no. 1, Second floor Hair department 327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08041125934  
Fax  08040917253  
Email  mukesh.ramnane@msclinical.com  
 
Source of Monetary or Material Support  
Marico Limited, MARKS, plot no:23-C Mahakalli Caves Road Andheri (E) Mumbai-400093 
 
Primary Sponsor  
Name  Marico Limited 
Address  MARKS, plot no:23-C Mahakalli Caves Road Andheri (E) Mumbai-400093 
Type of Sponsor  Other [FMCG (Fast moving Consumer Goods)] 
 
Details of Secondary Sponsor  
Name  Address 
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 Mukesh Ramnane  MS Clinical Research Pvt. Ltd  Room no. 1, Second floor Hair department 327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 08041125934

mukesh.ramnane@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinicom  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male and female subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FM-9 Hair oil  Apply the required quantity while making small partition across the scalp. Start from front and move to the back for uniform application Leave the oil for 30 minutes or overnight (as per consumer regular habit) and wash the next day with the provided shampoo. 
Comparator Agent  Not applicable  Not Applicable 
Intervention  XW-1 Hair oil  Apply the required quantity while making small partition across the scalp. Start from front and move to the back for uniform application Leave the oil for 30 minutes or overnight (as per consumer regular habit) and wash the next day with the provided shampoo. 
Intervention  ZT-6 Hair oil  Apply the required quantity while making small partition across the scalp. Start from front and move to the back for uniform application Leave the oil for 30 minutes or overnight (as per consumer regular habit) and wash the next day with the provided shampoo. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male and female subjects in general good health.
2. Subjects in the age group 18-50 years (both the ages inclusive).
3. Subjects complaining of hair fall and damage.
4. Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
5. Hair density of greater than 100 and less than 200 hair follicle per square cm as per TrichoScan measurement
6. Male and female Subjects falling under Grade 3 - Grade 6 of hair loss severity grade evaluated as per MSCR photo numerical 10-point scale (Linear scale for assessment purpose-In Use Scale).
 
 
ExclusionCriteria 
Details  1 Subjects who have undergone any kind of hair growth treatment in the last 3 months
2 Subjects having any active but controllable scalp disease which may interfere in the study assessments
3 Subjects who have taken chemotherapy for cancer in the 6 months prior to the studys start
4 Subjects who have history of crash dieting and or psychiatric disorder including trichotillomania
5 Subjects who have undergone hair transplant
6 A known history or present condition of allergic response or hypersensitivity to any topical or oral cosmetic pharmaceutical or nutraceutical product
7 Subjects on oral medications like topical or systemic corticosteroids undergoing any chemical hair salon treatment which will compromise the study
8 Subjects with chronic illness which may influence the cutaneous state
9 Subjects who are pregnant or nursing Self declared
10 Subjects with any history or present of underlying uncontrolled medical illness or any other serious medical illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Reduction in hair fall by comb test
• Improvement in hair growth rate, hair thickness, hair density by TrichoScan and dermatological assessments
• Change in anagen and telogen ratio by TrichoScan 		 at Baseline, Week 2, Week 4, Week 8, Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in hair thinning by dermatologists
• Overall safety of test product
• Change in density of vellus hair & terminal hair 		 at Baseline, Week 2, Week 4, Week 8, Week 12 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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 2 
Date of First Enrollment (India)   14/03/2024 
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="0"
Months="3"
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  

The study is designed to investigate the effectiveness and safety of a new product related to hair growth. It will be conducted in a single location, with a double-blinded, randomized approach. The study will last for 12 weeks, involving 10 visits for participants. The first two visits focus on screening, randomization, and baseline assessments. Subsequent visits include shaving and assessment, along with follow-up assessments at different time points. Participants will be divided into three test groups, and after the initial 4 weeks, only two of these groups will continue with the study. Various assessments, including TrichoScan® (a method for hair assessment), will be conducted throughout the study. Participants will be instructed to discontinue any other hair care medications during the study, and they will receive the assigned test product along with a neutral shampoo. Regular follow-up visits will assess the participants’ progress, and those who discontinue the study will sign an exit form. The study aims to gather information on the effects of the test product on hair growth.
 
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