Status:
RECRUITING
Effects of KSM-66 Ashwagandha® (300 mg) on Skin and Hair Health in Healthy Men and Women"
Lead Sponsor:
SF Research Institute, Inc.
Conditions:
Skin Health
Hair Health
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Hair and skin play major roles in protecting the body, and maintaining their health is essential. Poor hair and skin health have become increasingly common due to the stress associated with modern lif...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07215689
Start Date
July 11 2025
End Date
December 10 2025
Last Update
October 15 2025
Active Locations (1)
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1
San Francisco Research Institute
San Francisco, California, United States, 94132