CTRI/2023/06/053920招募中Unknown
A Prospective, Randomized, Double-Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Serum Application on the Hair Health in Healthy Adults
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 60 Second Hair Comb test
研究概览
简要总结
All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
Subjects will be informed about the purpose of the study and signed informed consent will be taken.
The efficacy assessments mentioned above will be done appropriately during the study.
All Subjects will be followed-up during the study period (Screening /Baseline, Day-45 (telephonic),and Day 90 ± 4) till complete the course of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult healthy male/ female participants ≥ 18 years and ≤45 years of age.
- •Willingness to follow the protocol requirements as evidenced by written informed consent.
- •Participants who agree not to use any medication (prescription and over the counter), including vitamins and minerals, during or before the course of this study.
- •Participants with mild to moderate hair loss classified as the Norwood-Hamilton type II, III, IV and V in males and Ludwig type I and II in females.
- •Participants willing to come for all follow-up visits.
- •Participants agreeing for not cutting hair for the entire duration of study.
- •Participants willing to undergo Trichoscan preparation and not to wash their hair 48 hour before the visit.
- •Participants willing to follow consistent dietary, hair product usage during the study.
- •Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- •Participants who agree to take investigational product (i.e., Till Day 90 ± 4).
排除标准
- •Participants having any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •Participants on any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement.
- •Participants having a history of hypersensitivity reactions.
- •Participation in a clinical study during the preceding 180 days
- •Participants who have undergone or plan to undergo hair transplantation surgery during the study period.
- •Pregnant and lactating females.
- •Participants with severe seborrheic dermatitis, alopecic disease (except for androgenic alopecia) and scalp disorders, such as scalp psoriasis and infection.
- •Participants with any disease or condition of the skin that the investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis.
- •Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).
结局指标
主要结局
60 Second Hair Comb test
时间窗: Baseline, 12 weeks
次要结局
- MSCR 10-point scale score
- Hair pull test score(Baseline, 12 weeks)
- Hair-specific Skindex-29(Baseline, 12 weeks)
研究者
研究点 (1)
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