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CTRI Number  CTRI/2025/08/093853 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Hair Growth Study]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to check how well a hair serum, alone or with gummies, works compared to a placebo in reducing hair fall and helping hair grow in men and women 
Scientific Title of Study   A Randomized, Placebo-Controlled, Parallel-Group Comparative Clinical Study to Evaluate the Efficacy and Safety of a Hair Serum Alone and in Combination with Gummies, Compared to Placebo, in Reducing Hair Fall and Promoting Hair Growth in Male and Female Participants. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HAIR/MWHS/2025-01 version 1.0 dated 01 Aug 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suhail Khan M K 
Designation  Principal Investigator 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  918040917253  
Fax    
Email  suhail.khan@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director business and operation  
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  ritambhara@msclinical.com  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  Manager Techno-commercial 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road Cambridge layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
Mosaic Wellness Pvt Ltd 6th Floor, Thane One Corporate IT Park, Ghodbunder Road, Kapurbawdi Thane West- 400610  
 
Primary Sponsor  
Name  Mosaic Wellness Pvt Ltd 
Address  6th Floor, Thane One Corporate IT Park, Ghodbunder Road, Kapurbawdi Thane West- 400610  
Type of Sponsor  Other [Other [Cosmetics]] 
 
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 Suhail Khan M K  MS Clinical Research Pvt. Ltd  327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA 		 91 80 40917253

suhail.khan@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE In  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Male and Female participants with hairfall 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hair serum  Apply 1ml of the serum directly to the entire scalp and massage for two minutes. Keep overnight or minimum of 6 hours Use it twice daily Once in the morning and again at night before bed. 
Intervention  Hair serum and Gummies  Hair Serum: Apply 1ml of the serum directly to the entire scalp and massage for two minutes. Keep overnight or minimum of 6 hours Use it twice daily Once in the morning and again at night before bed. Gummies: The total daily dose is approximately 3.7g, which is administered as one gummy taken orally. One gummy every day after breakfast. 
Comparator Agent  Placebo (Control)  Apply 1ml of the serum directly to the entire scalp and massage for two minutes. Keep overnight or minimum of 6 hours Use it twice daily Once in the morning and again at night before bed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Trial participants in the age group 18-40 years.
2. Female and male trial participants in the ratio 7:3 in all three groups.
3. Trial participants willing to undergo shaving of a test area on the scalp and have a
mark in the target area.
4. Trial participants able to read, understand, and provide informed consent.
5. Trial participants willing to give a written informed consent and willing to abide by
and comply with the study protocol.
 
 
ExclusionCriteria 
Details  1. Trial participants who have undergone any kind of hair growth treatment in the last
3 months
2. Trial participants having any active scalp disease which may interfere with the
study
3. Prior use of scalp hair growth treatment within 6 months.
4. Trial participants who have taken chemotherapy for cancer in the 6 months prior to the study start.
5. Trial participants who have undergone hair transplant.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare hair growth from baseline
at all subsequent time points in trial participants receiving Hair Serum alone, Hair Serum combined with Hair Vitamin Gummies, and Placebo, as measured by TrichoScan.
2. To evaluate and compare hair density from baseline
at all subsequent time points in participants receiving
Hair Serum alone, Hair Serum combined with Hair Vitamin Gummies, and Placebo, as measured by TrichoScan.
3. To evaluate and compare change in anagen to
telogen ratio (A/T ratio) at day 86 in comparison to
baseline as measured by TrichoScan 		 Week 0, Week 4, Week 8, Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate hair fall by comb test in comparison to
baseline and all defined time points.
2. To evaluate reduction in hair thinning using standard
photo numeric scale (1-10) in comparison to baseline
and all defined time points.
3. To evaluate hair thickness assessment using
Caselite software in comparison to baseline and all
defined time points.
4. To evaluate and compare change in hair growth by
Dermatological assessment and Participant self
assessment at all defined time points. 		 Week 0, Week 4, Week 8, Week 12 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   09/09/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="12" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

This study will enroll 105 male and female participants (7:3 ratio) who meet the eligibility criteria and provide informed consent. The study is designed to compare the test products with placebo, as well as evaluate differences within the treatment groups, At screening (Visit 1, Day –16), participants will undergo health screening, medical history, and dermatological evaluation, followed by a Trichoscan at Visit 2 (Day –14) before a two-week washout period, during which they will stop all hair growth products and use a neutral shampoo.

Baseline assessments at Week 0 (Visit 3, Day 0) will include imaging, dermatological and instrumental tests, hair comb test, Trichoscan, and self-assessment. At Visit 4 (Day 2), participants will undergo Trichoscan, be randomized into three groups, receive the study product, and start daily diary recording.

Follow-up visits at Weeks 4, 8, and 12 will repeat baseline assessments. The final visit will include product and diary collection and study exit procedures. Site application reactions, concomitant medications, and any adverse events will be monitored throughout.

 
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