CTRI/2023/06/053659招募中4 期
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 & Women
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy adult men and women participants >= 18 years and <=60
- •years of age.
- •2. Willingness to follow the protocol requirements as evidenced by
- •written informed consent.
- •3. 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.
- •4. 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.
- •5. 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.
- •6. Willing to come for all follow-up visits.
- •7. Participants who agree not to cut hair for the entire duration of the
- •8. Participants willing to undergo Trichoscan evaluation and not to
- •wash their hair 48 hours before the visit.
- •9. Participants willing to take proper contraceptives during the study
- •and period.
- •10. Participants or LAR can and willing to give meaningful, written
- •informed consent prior to participation in the trial, in accordance
- •with regulatory requirements.
- •11. Participants who agree to take investigational product (i.e., Till Day
- •90 ± 4 ± 4).
排除标准
- •1. 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.
- •2. 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.
- •3. Participants having a history of hypersensitivity reactions (i.e.,
- •allergic or oversensitivity to study medication).
- •4. Participants who have undergone or plan to undergo hair
- •transplantation surgery during the study period.
- •5. Participants with facial skin cancer.
- •6. Participants with sunburn, moderate to pronounced suntan, uneven
- •skin tones, tattoos, scars or other disfiguration, dilated vessels or
- •other conditions on the test area that might influence the test results.
- •7. Participants with severe seborrheic dermatitis, alopecic disease,
- •except for androgenic alopecia, and scalp disorders, such as scalp
- •psoriasis and infection
- •8. Participants who have participated in a clinical study during the
- •preceding 180 days.
- •9. Participants having eating disorders (i.e., bulimia, psychogenic
- •eating disorders, etc.).
- •10. Pregnant and lactating females
- •11. Participants with alcohol addiction or persistent abuse of drugs of dependence.
研究者
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