Clinical trial of Hair care supplements

Phase 3

Not yet recruiting

• Conditions: Hair related complaints

• Registration Number: CTRI/2022/12/048388
• Lead Sponsor: Life Synergy

Brief Summary

Considering the etiological basis of hair loss and hair and scalp-related complaints in nutritional deficiencies, the interventions like micronutrients and phytoconstituent blend can promote hair, nail and skin-related health. The current study is to validate the safety and efficacy of hair care supplements in healthy female subjects with hair and scalp related complaints

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-20
• Study Start: 2022-12-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• 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.

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.
• 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
-Hair density and thickness	From baseline to day 90
-Terminal and vellus hair density	From baseline to day 90
Skin health assessment by CLBT score	From baseline to day 90
Changes in number of shredded hairs in 60 second Hair comb test	From baseline to day 90
Changes in number of shredded hairs in Hair wash test	From baseline to day 90
Assessment by photo trichogram-	From baseline to day 90
-% Anagen and telogen Hair	From baseline to day 90
-Hair growth rate (mm/day)	From baseline to day 90

Secondary Outcome Measures

Name	Time	Method
To assess nail growth and satisfaction scale on nail health	To assess improvement in the “Hair Quality Assessment Questionnaire†from baseline to End of the study. (Brittleness, thinning, dryness and damaged hair, luster, roughness, fizziness)

Trial Locations

Locations (1)

Atharv Medical Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Atharv Medical Research Center

🇮🇳Pune, MAHARASHTRA, India

Dr Ninad Naik

Principal investigator

9422089260

drnaik2023@gmail.com