Study on Hair Serum & Vitamin Gummies for Reducing Hair Fall and Growth Improvement.

Phase 2

Not yet recruiting

• Conditions: Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,

• Registration Number: CTRI/2025/04/084228
• Lead Sponsor: Mosaic Wellness Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-16
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male/ Female participants in general good health; 2.
• Participants in the age group 18-40 years (both ages inclusive).
• 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.
• 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.
• 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.
• Participants must be willing and able to comply study regimen and requirements in a timely manner.

Exclusion Criteria

• Participants who are undergoing hair growth treatment within 3 months before screening for the study.
• Participants having any active scalp disease which may interfere with the study.
• Prior use of scalp hair growth treatment (e.g. finasteride, minoxidil) within 6 months.
• Participants on treatment for active acne.
• Participants with a history or active phase of malignancy and chemotherapy.
• Participants who have a history of alcoholism and/ or psychiatric disorders including trichotillomania.
• Participants who take pharmaceutical products which cause hirsutism.
• Participants on oral hair growth medications which will compromise the study.
• Chronic illness which may influence the study 10.
• Pregnant or lactating mothers.
• Participant willing to continue his current regimen of vitamins, nutraceutical, herbal, or ayurvedic supplements for the duration of the study for hair health.
• Participant on any medication known to cause hair loss or hair thinning (e.g. Isotretinoin).
• 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.
• Any prior hair growth procedures (e.g., hair transplant or laser).
• Diagnosed with dermatologic conditions like eczema, fungal scalp infections, seborrheic dermatitis, recurrent herpes, pityriasis versicolor, psoriasis, pigmentary disorders (vitiligo, chloasma), chronic lupus erythematous.
• Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. Change in anagen to telogen ratio (A/T ratio)	screening, day 30, day 60 and day 90
3. Change in the hair growth rate in the target area by Phototrichogram	screening, day 30, day 60 and day 90
1. Change in the hair density and follicular density in the target area by Phototrichogram	screening, day 30, day 60 and day 90

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Lokmanya Medical Research Centre and Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Miracle Touch Skin, Laser and Cosmetic surgery clinic; 🇮🇳 Pune, MAHARASHTRA, India

Lokmanya Medical Research Centre and Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Hemant Talnikar

Principal investigator

9422087726

talnikarhemant@gmail.com