CTRI/2022/09/045770进行中（未招募）不适用
A Prospective, Randomized, Double-Blind, Placebo Controlled Clinical Study to Evaluate the Effects of KSM-66 Ashwagandha® capsule (300 mg) on Skin and Hair Health in Healthy Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Trans Epidermal Water Loss (TEWL) Assessment
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.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult men and women participants ≥ 18 years and ≤60 years of age.
- •Willingness to follow the protocol requirements as evidenced by written informed consent.
- •Participants who were on consistent dietary, hair, and skin product 3 months prior to start of the study and are willing to follow the same during the study.
- •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.
- •Willing to come for all follow-up visits.
- •Participants who agree not to cut hair for the entire duration of the study.
- •Participants willing to undergo Trichoscan evaluation and not to wash their hair 48 hours before the visit.
- •Participants willing to take proper contraceptives during the study and period.
- •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 ± 4).
排除标准
- •Participants having any clinically significant medical history, medical finding including rosacea, eczema, psoriasis, and atopic dermatitis or an on-going 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 (i.e., allergic or oversensitivity to study medication).
- •Participants who have undergone or plan to undergo hair transplantation surgery during the study period.
- •Participants with facial skin cancer.
- •Participants with severe seborrheic dermatitis, alopecic disease, except for androgenic alopecia, and scalp disorders, such as scalp psoriasis and infection
- •Participants who have participated in a clinical study during the preceding 180 days.
- •Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).
- •Pregnant and lactating females
- •Participants with alcohol addiction or persistent abuse of drugs of dependence.
结局指标
主要结局
Trans Epidermal Water Loss (TEWL) Assessment
时间窗: Baseline, 12 Weeks
次要结局
- Trichoscan analysis(Baseline, 12 Weeks)
- DLQI Questionnaire score(assessment)
- Hair Skindex-29 Questionnaire(score assessment)
- Subjects Self-Assessment of(improvement)
- Clinical Global Impression – Improvement scale (CGI-I)(Baseline, 12 Weeks)
研究者
研究点 (1)
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