CTRI/2022/11/047577已完成未知
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
Ixoreal Biomed0 个研究点目标入组 92 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 92
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 more than equal to 18 years and less than equal to 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
- •5.Participants with mild to moderate hair loss.
- •6.Willing to come for all follow-up visits.
- •7.Participants who agree not to cut hair for the entire duration of the study.
- •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 are able to 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 75 ± 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 alpha-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
相似试验
尚未招募
3 期
To assess the Safety and Effectiveness of Supplementation of Lutein Formulations on Improving Macular Pigment Optical DensityCTRI/2023/11/060356India Glycols Limited
招募中
4 期
Effectiveness of Ashwagandha Serum on the Hair Health in AdultsCTRI/2023/06/053920Ixoreal Biomed Private Limited
招募中
4 期
Effectiveness of Ashwagandha capsule on Skin & Hair Health in Healthy adultCTRI/2023/06/053659Ixoreal Biomed Private Limited
招募中
Unknown
Effectiveness of Ashwagandha topical lotion on the Skin Health in Healthy AdultsCTRI/2023/06/054483Ixoreal Biomed Private Limited
进行中（未招募）
不适用
To Evaluate the Effects of Ashwagandha capsule on Skin and Hair Health in Healthy adultsCTRI/2022/09/045770Ixoreal Biomed Private Limited