KSM-66 Ashwagandha 300 mg for improving skin hydration, elasticity, and hair strength

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

This trial will test whether taking a 300 mg KSM-66 Ashwagandha capsule can improve skin hydration, elasticity, barrier function, and hair density in healthy adults with mild to moderate hair loss.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: SF Research Institute, Inc. (network)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07215689 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial will enroll healthy men and women aged 18–60 with mild to moderate hair loss and randomize them to receive either a 300 mg KSM-66 Ashwagandha capsule or placebo for the study duration. Outcomes include validated questionnaires, dermatological examinations, and instrumental measurements of skin hydration, elasticity, barrier function, and hair density/strength such as Trichoscan. Participants must maintain consistent dietary, hair, and skin product routines and avoid other medications or supplements to limit confounding. The study tests whether Ashwagandha's adaptogenic, stress-modulating effects lead to measurable improvements in skin and hair health.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18–60 with mild to moderate hair loss who can avoid other medications and keep hair and skin product routines stable during the study.

Not a fit: People with severe hair loss, active dermatologic disease, or those unwilling to stop other medications or change grooming routines are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, supplementation could offer a safe, natural option to improve skin hydration, elasticity, and hair density and possibly reduce stress-related hair shedding.

How similar studies have performed: Prior research shows Ashwagandha can reduce stress markers like cortisol, but direct, consistent clinical evidence for improved hair and skin outcomes is limited.

Eligibility criteria

Inclusion Criteria:

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 study.
8. Participants willing to undergo Trichoscan evaluation and not to wash their hair 48 hours before the visit.
9. Participants or LAR can 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 90 ± 4 ± 4).

Exclusion Criteria:

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.

Where this trial is running

San Francisco, California

• San Francisco Research Institute — San Francisco, California, United States (RECRUITING)

Study contacts

• Study coordinator: Dr. John Ademola

Conditions: Skin Health, Hair Health