Clinical trial of Hair care supplements

Phase 3

Registration Number: CTRI/2022/12/048420

Lead Sponsor: ife Synergy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Male subjects in general good health, subjects in the age group 18-60 years, subjects willing to to give written informed consent and agree to come for a regular follow up visit, subjects not participated in a similar investigations in the past two weeks,subjects complaining of hair fall and damage, subjects who are not on crash dieting, subjects who agree to not to change the brand of currently used hair color, dye, treatment etc., if during the study term,subjects willing to refrain from any type of hair treatment like head massage, oil application, perming, etc. during the study duration, subjects with at least of two of

following complaints- hair loss, dry damaged hair, brittle and thin hair, premature greying of hair, scalp related complaints like itching, dandruff or irritation

Exclusion Criteria

Subjects who are undergoing hair growth treatment within 3 months before screening into the study.

Subjects having any active scalp disease which may interfere in the study.

Subjects on treatment for active acne

Subjects with history or active phase of malignancy and chemotherapy therefore.

Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.

Subjects who have had hair transplant.

Subjects who take pharmaceutical product which cause hirsutism.

Subjects on oral hair growth medications which will compromise the study.

Chronic illness which may influence the study.

Subjects participating in other similar cosmetic or therapeutic trial within last two weeks

Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, serious disorder of heart and respiratory apparatus or any other

serious medical illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in shredded hair strands in 60 second Hair comb test <br/ ><br>Changes in number of shredded hairs in Hair <br/ ><br>wash test <br/ ><br>Assessment by photo trichogram- <br/ ><br>-% Anagen and telogen Hair <br/ ><br>-Hair density and thickness <br/ ><br>-Terminal and vellus hair density <br/ ><br>-Hair growth rate (mm/day) <br/ ><br>Skin health assessment by CLBT scoreTimepoint: From baseline to day 90

Secondary Outcome Measures

Name	Time	Method
To assess nail growth and satisfaction scale on <br/ ><br>nail health <br/ ><br>To assess improvement in the â??Hair Quality <br/ ><br>Assessment Questionnaireâ?? from baseline to <br/ ><br>End of the study. (Brittleness, thinning, dryness <br/ ><br>and damaged hair, luster, roughness, fizziness) <br/ ><br>To assess VAS- Visual analog scale scalp <br/ ><br>related complaints like itching, dandruff or <br/ ><br>irritation (Scalp health) tolerability including the <br/ ><br>ocular irritant potential and non-irritant potential <br/ ><br>on skinTimepoint: From baseline to day 90