Clinical trial of Hair care supplements
- Registration Number
- CTRI/2022/12/048388
- Lead Sponsor
- ife Synergy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Female 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
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.
Subjects who are pregnant lactating or nursing as established with medical history.
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 number of shredded hairs in 60 second Hair comb test <br/ ><br>Changes in number of shredded hairs in Hair 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 nail health <br/ ><br>To assess improvement in the â??Hair Quality Assessment Questionnaireâ?? from baseline to End of the study. (Brittleness, thinning, dryness and damaged hair, luster, roughness, fizziness) <br/ ><br>To assess VAS- Visual analog scale scalp related complaints like itching, dandruff or irritation (Scalp health) tolerability including the ocular irritant potential and non-irritant potential on skinTimepoint: From baseline to day 90