| CTRI Number |
CTRI/2025/04/084228 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on Hair Serum & Vitamin Gummies for Reducing Hair Fall and Growth Improvement. |
|
Scientific Title of Study
|
A randomized, controlled, parallel-arm, open-label clinical trial to evaluate the safety and efficacy of Hair Serum alone or in combination with Hair vitamin gummies in reducing hair fall and improving hair growth in adult male and female participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/060 Version: 1.00 dated 12 Feb 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Talnikar |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Fourth Floor OPD 401-314 Telco Road Chinchwad, Pune
Pune
MAHARASHTRA
411033
India |
| Phone |
919422087726 |
| Fax |
- |
| Email |
talnikarhemant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Darshani Mohan |
| Designation |
Associate Director R&D Food and Nutra |
| Affiliation |
Mosaic Wellness Pvt Ltd |
| Address |
6XCG 9F3, Thane One Corporate Business IT Park Thane One, Ghodbunder Road,Kapurbawdi, Thane West
Mumbai
MAHARASHTRA
400610
India |
| Phone |
9677449243 |
| Fax |
- |
| Email |
darshani.m@mosaicwellness.in |
|
Details of Contact Person
Public Query
|
| Name |
Shreyans Jain |
| Designation |
Senior Manager NPD |
| Affiliation |
Mosaic Wellness Pvt Ltd |
| Address |
6XCG 9F3, Thane One Corporate Business IT Park Thane One, Ghodbunder Road,Kapurbawdi, Thane West
Mumbai
MAHARASHTRA
400610
India |
| Phone |
07506946496 |
| Fax |
- |
| Email |
shreyans.jain@mosaicwellness.in |
|
|
Source of Monetary or Material Support
|
| Mosaic Wellness Pvt Ltd
6XCG 9F3, Thane One Corporate Business IT Park, Thane One, Ghodbunder Rd, Kapurbawdi, Thane West, Thane, Maharashtra 400610
|
|
|
Primary Sponsor
|
| Name |
Mosaic Wellness Pvt Ltd |
| Address |
6XCG 9F3, Thane One Corporate Business IT Park, Thane One, Ghodbunder Rd, Kapurbawdi, Thane West, Thane, Maharashtra 400610 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemant Talnikar |
Lokmanya Medical Research Centre and Hospital |
Fourth floor OPD 314 B Telco Road Chinchwad Pune
Pune
MAHARASHTRA |
9422087726
-
talnikarhemant@gmail.com |
| Dr Shraddha Patil |
Miracle Touch Skin, Laser and Cosmetic surgery clinic |
Pimple Saudagar, Pune 411027
Pune
MAHARASHTRA |
7709502751
-
drshraddhapatil27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Lokmanya Medical Research Centre |
Approved |
| Institutional Ethics Committee of Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 serum |
Apply 1ml of the serum directly to the entire scalp and massage for two minutes. Use it twice daily: once in the morning and again at night before bed, for a duration of 3 months. Keep overnight or minimum of 6 hours. Avoid applying the serum immediately before shampooing. |
| Intervention |
Hair Serum + Hair vitamin gummies |
The total daily dose is approximately 3.7g, which is administered as one gummy taken orally every day after breakfast for a duration of 90 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Male/ Female participants in general good health;
2. Participants in the age group 18-40 years (both ages inclusive).
3. Participants falling under Grade I-1 to II-1 or frontal of savins pictorial grading of female pattern hair loss or under Grade 2 to 4A of hair loss severity grade evaluated as per Norwood scale.
4. Participant 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.
5. Willingness to maintain the same hair style, approximate length, and hair color throughout the study
6. Able to read, understand, and provide written (signed) informed before study starts.
7. Participants must be willing and able to comply study regimen and requirements in a timely manner.
|
|
| ExclusionCriteria |
| Details |
1. Participants who are undergoing hair growth treatment within 3 months before screening for the study.
2. Participants having any active scalp disease which may interfere with the study.
3. Prior use of scalp hair growth treatment (e.g. finasteride, minoxidil) within 6 months.
4. Participants on treatment for active acne.
5. Participants with a history or active phase of malignancy and chemotherapy.
6. Participants who have a history of alcoholism and/ or psychiatric disorders including trichotillomania.
7. Participants who take pharmaceutical products which cause hirsutism.
8. Participants on oral hair growth medications which will compromise the study.
9. Chronic illness which may influence the study
10. Participants participating in another similar cosmetic or therapeutic trial within the last two weeks.
11. Pregnant or lactating mothers.
12. Participant willing to continue his current regimen of vitamins, nutraceutical, herbal, or ayurvedic supplements for the duration of the study for hair health.
13. Participant on any medication known to cause hair loss or hair thinning (e.g. Isotretinoin).
14. Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
15. Known hypersensitivity to investigational product or its excipients.
16. Any prior hair growth procedures (e.g., hair transplant or laser).
17. Diagnosed with dermatologic conditions like eczema, fungal scalp infections, seborrheic dermatitis, recurrent herpes, pityriasis versicolor, psoriasis, pigmentary disorders (vitiligo, chloasma), chronic lupus erythematous.
18. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in the hair density and follicular density in the target area by Phototrichogram
2. Change in anagen to telogen ratio (A/T ratio)
3. Change in the hair growth rate in the target area by Phototrichogram |
screening, day 30, day 60 and day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in the number of terminal hairs, vellus hairs and and hair diameter in the target area by phototrichogram
2. Changes in number of hair shredded by 60 second hair comb test
3. Change in the number of shredded hairs after “Modified hair wash test”
4. Change in "Participant-Perceived Self-Hair Assessment Questionnaire" score
5. Change in visual analog scale (VAS) score for scalp related complaints like itching, dandruff or irritation reported by participants. |
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)= "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)
|
16/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Hair is a crucial aspect of our appearance and personality, reflecting our health and well-being. Healthy hair typically has a smooth texture, dense volume, natural color, shine, and a significant number of hairs in the growing phase. However, hair loss is a common and distressing condition influenced by various genetic, nutritional, medical, and environmental factors. Hair goes through a repeated growth cycle with three distinct phases: anagen (3 to 5 years), catagen (2 to 3 weeks), and telogen (3 to 4 months), followed by shedding of hair. During the telogen or resting phase, hair is released and shed, and the next cycle is initiated. Modern lifestyles, characterized by poor diets and increased pollution, worsen hair loss. Beyond physical aspects, hair loss also has psychological effects, impacting an individual’s self-perception. Micronutrients play a major role in the hair follicle cycle. Hair loss can be influenced by stress, genetics, irregular sleep patterns, and poor gut health. This highlights the need for interventions that address both nutritional deficiencies and external factors to promote hair growth and prevent hair loss. Previous research indicates the potential benefits of hair vitamin gummies. A study evaluated the efficacy of Hair Vitamin Gummies, which contain a blend of multivitamins (Vitamin A, B3, B5, B6, Folic Acid, B12, C, D2, and E), biotin, iodine, selenium, zinc, choline, inositol, and amla (Indian Gooseberry) fruit extract. The results showed improvements in the anagen and telogen ratio, hair density, hair growth, hair thickness, hair strength, and hair gloss/shine. Participants reported denser hair, good shininess, and a reduction in hair dullness, with 93.75% reporting full hair volume at the end of the study. A randomized, controlled, parallel-arm, open-label clinical trial aims to evaluate the safety and efficacy of Hair Serum alone or in combination with Hair Vitamin Gummies in reducing hair fall and improving hair growth in adult male and female participants. The study will involve two groups: Group 1 will be treated with Hair Serum only, and Group 2 will be treated with Hair Serum and Hair Vitamin Gummies. By comparing the outcomes of these two groups, this clinical trial aims to determine whether the combination therapy offers superior benefits in promoting hair growth and improving overall hair health compared to Hair Serum alone. The results of the clinical study indicate that the gummies effectively promote hair growth and prevent hair loss. |