Effects of KSM-66 Ashwagandha® (300 mg) on Skin and Hair Health in Healthy Men and Women"

This randomized, double-blind, placebo-controlled clinical study is designed to evaluate the effects of KSM-66 Ashwagandha® (300 mg capsule) on hair and skin health in healthy men and women. The study aims to assess whether Ashwagandha supplementation can improve parameters related to skin hydration, elasticity, and barrier function, as well as hair density and strength.

Participants will be randomized to receive either KSM-66 Ashwagandha or placebo for the study duration. The assessments will include validated questionnaires, dermatological evaluations, and instrumental measurements of skin and hair parameters. The results are expected to provide evidence on the potential efficacy and safety of Ashwagandha in supporting hair and skin health through its adaptogenic and stress-modulating properties.

Inclusion criteria

• 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 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).

Exclusion criteria

• 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 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.
• 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.