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CTRI Number  CTRI/2023/03/050199 [Registered on: 01/03/2023] Trial Registered Prospectively
Last Modified On: 10/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical trial of hair vitamin gummies to improve hair and nail health 
Scientific Title of Study   A Randomized double-blind placebo-controlled clinical trial to evaluate the safety and efficacy of hair vitamin gummies in reducing hair fall and improving hair and nail health in adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/22-23/010 Version: 1.00 dated 05 Jan 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemant Talnikar 
Designation  Consultant 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Lokmanya Medical Research Center,4th floor 314/B, Near Chinchwad railway station, Telco road, Chinchwad, lndia.

Pune
MAHARASHTRA
411033
India 
Phone  9422087726  
Fax  -  
Email  talnikarhemant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek C Kanade 
Designation  Sr. Manager – NPD & OPerations 
Affiliation  Mosaic Wellness Pvt. Ltd. 
Address  Mosaic Wellness Pvt. Ltd., Awfis, 5th floor, Vaman Techno Centre, Marol, Andheri East

Mumbai
MAHARASHTRA
400059
India 
Phone  9029243493  
Fax  -  
Email  abhishek.kanade@mosaicwellness.in  
 
Details of Contact Person
Public Query
 
Name  Abhinav Gupta 
Designation  Director – NPD & OPerations 
Affiliation  Mosaic Wellness Pvt. Ltd. 
Address  Mosaic Wellness Pvt. Ltd., Awfis, 5th floor, Vaman Techno Centre, Marol, Andheri East

Mumbai
MAHARASHTRA
400059
India 
Phone  8879972102  
Fax  -  
Email  abhinav@mosaicwellness.in  
 
Source of Monetary or Material Support  
Mosaic Wellness Pvt Ltd Awfis, 5th Floor, Vaman Techno Centre, Marol, Andheri East, Mumbai, Maharashtra 400059 
 
Primary Sponsor  
Name  Mosaic Wellness Pvt Ltd  
Address  Awfis, 5th Floor, Vaman Techno Centre, Marol, Andheri East, Mumbai, Maharashtra 400059 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonal Shendkar  Imperial Multispecialty Hospital  Pingale Pride, Gat No. 1193, Pingale Road, Near Radha swami Ashram, Chikhali, Pune – 411062.
Pune
MAHARASHTRA 
9960178611
-
shendkar.sonal82@gmail.com 
Dr Hemant Talnikar  Lokmanya Medical Research Centre and Hospital  4th floor 314/B, Near Chinchwad railway station, Telco road, Chinchwad, Pune, lndia.
Pune
MAHARASHTRA 
9422087726
-
talnikarhemant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Lokmanya Medical Research Centre and Hospital  Approved 
Lokmanya Medical Research Centre and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hair Vitamin gummies  1 gummy per day after breakfast for the treatment group for 90 days. 
Comparator Agent  Placebo Gummy  1 gummy per day after breakfast for placebo group for 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Male and female subjects in general good health;
2.Subjects in the age group of 18-35 years (both inclusive);
3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit;
4. Female subjects falling under Grade roman number one-1 to roman number two-1 of Savins pictorial grading of female pattern hair loss or male subjects falling under Grade two to four A of hair loss severity grade evaluated as per Norwood scale;
5.Subject with at least one of the following complaints-
•Dry damaged hair
•Brittle and thin hair
•Hair loss evident while combing or after washing
•Perceived reduced hair density
•Scalp related complaints like itching, dandruff or irritation. 
 
ExclusionCriteria 
Details  1.Subjects who are undergoing hair growth treatment within 3 months before screening into the study;
2.Subjects having any active scalp disease which may interfere in the study;
3.Subjects on treatment for active acne;
4.Subjects with history or active phase of malignancy and chemotherapy;
5.Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania;
6.Subjects who have had hair transplant;
7.Subjects who take pharmaceutical product which cause hirsutism;
8.Subjects on oral hair growth medications which will compromise the study;
9.Chronic illness which may influence the study;
10.Subjects participating in other similar cosmetic or therapeutic trial within last two weeks;
11.Pregnant or lactating mothers;
12.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension (›140/90 mmHg), HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness;
13.Any other condition, as per the discretion of the investigator, that can impact the study outcome or subjects will not be considered in the study.
 
 
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.Change in the hair density in the target area by phototrichogram at screening visit and end of the study.
2.Change in hair growth rate from screening visit to end of the study.
3.Change in anagen to telogen ratio (A/T ratio) at screening visit and end of the study. 
Screening, day 30, day 60 and day 90 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in the number of terminal hairs, vellus hairs and hair diameter in the target area by phototrichogram at screening visit and end of the study.
2.Change in the number of shredded hairs after “60 Second Hair Comb test” from screening to end of the study.
3.Change in the number of shredded hairs after “Modified hair wash test” from screening to end of the study.
4.Change in nail growth rate assessed by dermatologist from screening visit to end of the study.
5.Change in self-assessment questionnaire score for hair and nail at screening and end of the study.
6.Change in visual analog scale (VAS) score for scalp related complaints like itching, dandruff or irritation reported by subjects from screening to end of the study. 
Screening, day 30, day 60 and day 90 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/03/2023 
Date of Study Completion (India) 10/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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)  

Multiple studies have linked hair loss to negative feelings in both men and women and can contribute to stress, decrease body image satisfaction, diminish quality of life, lowered self-esteem and decreased confidence. Hairs are associated with vitality, virility, and beauty. Hair loss can lead to feelings unattractiveness, age and loss of strength. These effects are more pronounced in men and women who begin losing their hair at an early age. Individual with hair problem, especially thinning and balding is often thought to appear older since in our culture, losing one’s hair signifies getting older. For anyone who suffer from hair loss, regardless of gender, changes in self-esteem and confidence are challenging. It influences how one feel and perceived, both personally and professionally 

A Hair loss, formally known as alopecia, can happen for a variety of reasons, including age, hormonal imbalances, high stress levels and untreated medical conditions. A deficiency of nutrition may affect the growth and structure of hair. Micronutrient "shortfalls" can result from inadequate intakes, especially because dietary patterns that are energy-rich diets but void of nutrients. When dietary approaches like dietary modification, fortification, or food provision are unable to achieve adequate intake, vitamin supplements are needed.  Vitamin gummies are more palatable, convenient to administer, colorful, and come in a variety of flavors to suit the palate.

The present research is an attempt of clinical validation of vitamin hair gummies in subjects suffering from hair fall, and to improve hair & nail health. With the present clinical trial, we can provide nutrition in easy-to-use form, hassle free gummies to prevent and resolve nutritional deficiencies to get healthy and happy hairs & nails, every day. There is need to come up with a formulation for to promote regrowth of hair to improve scalp coverage, to prevent or slow further hair thinning and loss, treat dandruff and relieve itchy scalp which could be achieved through the present research. We can utilize these outcomes to develop a strategy to achieve healthier, nourished, thicker and stronger hair and nails.

The study has completed and the data is available with the sponsor of the study on individual request basis.

 
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