A parallel arm clinical trial to validate safety and efficacy of Hair care product range (LS/HC/001) in adult females.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in number of shredded hairs in 60 second Hair comb test
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in number of shredded hairs in 60 second Hair comb test
时间窗: From baseline to day 90
Changes in number of shredded hairs in Hair wash test
时间窗: From baseline to day 90
Assessment by photo trichogram-
时间窗: From baseline to day 90
-% Anagen and telogen Hair
时间窗: From baseline to day 90
-Hair density and thickness
时间窗: From baseline to day 90
-Terminal and vellus hair density
时间窗: From baseline to day 90
Skin health assessment by CLBT score
时间窗: From baseline to day 90
-Hair growth rate (mm/day)
时间窗: From baseline to day 90
次要结局
- 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))