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A clinical trial to evaluate the efficacy of micronutrients in reducing hair loss, to increase hair growth and to improve scalp conditions in the androgenic alopecia.

A prospective, randomized, double blind, placebo controlled, two arm, parallel assignment study to evaluate clinical efficacy and safety of Hair growth Lotion + Tablet in the management of Androgenic alopecia (AGA).

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/001054
Enrollment
60
Registered
2010-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Reducing hair loss, to increase hair growth and to improve scalp conditions in the androgenic alopecia.

Interventions

Intervention1: Micronutrients Lotion and Tablet: Gently massage the lotion (around 4ml- 5ml with the help of a dropper) on entire scalp every night, Take two tablets by mouth each day with main meal.

Sponsors

Meyer Organics Pvt Ltd Thane
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men aged 18 to 49 years with mild to moderate signs of AGA, which is classified in Modified Norwood-Hamilton Scale as stage 3V, 4 and 5. Not be on a course of treatment, which affects the outcome of the study. Individuals who are willing to give informed consent and willing to follow up. No topical treatment for AGA for at least 6 weeks and no systemic treatment for at least 3 months prior to study initiation. Willing to refrain from other AGA treatments during the course of the study. Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study.

Exclusion criteria

Exclusion criteria: Coexistent androgenetic alopecia other than 3V, 4 and 5 stages of Norwood-Hamilton scale Unwilling to maintain a consistent hair style and to avoid shaving of scalp hair throughout the course of the study. Unable to comply with the protocol. Patients who are on chronic oral steroids are not eligible for the study Allergies to Investigational product. Presence of irritated or visibly inflamed scalp. Use of ultraviolet radiation, including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation. Evidence of immunocompromise. Advanced or poorly controlled diabetes. Unstable cardiovascular disease. Clinically significant medical or psychiatric disease as determined by the investigator. Local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) within 3 months prior to the first dose of investigational drug. Those who have donated blood within a month of date of screening evaluation. Drug or alcohol abuse.

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measures Hair count by PTG (Phototrichograms)Timepoint: At baseline, 2,4 and 6 months

Secondary

MeasureTime frame
Secondary Outcome Measures 1.Self assessment by Patients 2.Physical examination of scalp 3.Hair density rating scale 4.Global assessment by investigator 5.Compliance and adverse effects Timepoint: 1.after 2 and 4 months 2.at baseline, after 1, 2, 3 and 4 months 3.after 2 and 4 months 4.After treatment completion 5.Compliance and adverse effects

Countries

India

Contacts

Public ContactDr Himanshu Tayade
orathod@meyer.co.in02581-7000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026