A Prospective, Double-Blind, Randomized, Parallel, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha topical formulation (Serum) on the hair health in healthy adult humans.

Ixoreal Biomed0 个研究点目标入组 68 人开始时间: 待定最近更新: 2024年7月22日

试验速览

暂无简介。

•1.Adult healthy male/ female participants more than equal to 18 years and less than equal to 45 years of age.
•2.Willingness to follow the protocol requirements as evidenced by written informed consent.
•3.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.
•4.Participants with mild to moderate hair loss.
•5.Participants willing to come for all follow-up visits.
•6.Participants agreeing for not cutting hair for the entire duration of study.
•7.Participants willing to undergo Trichoscan preparation and not to wash their hair 48 hour before the visit.
•8.Participants willing to follow consistent dietary, hair product usage during the study.
•9.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.
•10.Participants who agree to take investigational product (i.e., Till Day 75 ± 4).

•1.Participants having any clinically significant medical history, medical finding
•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
•2.Participants on any medication or supplement for hair loss, including
•finasteride, any other 5 aplha-reductase inhibitor, minoxidil, steroids, or hormonal
•products, during the 3 months prior to study commencement.
•3.Participants having a history of hypersensitivity reactions.
•4.Participation in a clinical study during the preceding 180 days.
•5.Participants who have undergone or plan to undergo hair transplantation
•surgery during the study period.
•6.Pregnant and lactating females.
•7.Participants with severe seborrheic dermatitis, alopecic disease (except for
•androgenic alopecia) and scalp disorders, such as scalp psoriasis and infection.
•8.Participants with any disease or condition of the skin that the investigator
•deems inappropriate for participation, including rosacea, eczema, psoriasis, and
•atopic dermatitis.
•9.Participants having eating disorders (i.e., bulimia, psychogenic eating
•disorders, etc.).

发起方

Ixoreal Biomed