Actively Recruiting
Effects of KSM-66 Ashwagandha® Capsule (300 mg) on Skin and Hair Health in Healthy Men and Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Study
Led by SF Research Institute, Inc. · Updated on 2025-10-15
50
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of KSM-66 Ashwagandha® capsules on hair and skin health in healthy men and women aged 18 to 60. This study addresses the common issues of hair loss, baldness, and skin problems linked to stress in modern lifestyles. While these conditions are not life-threatening, they can lead to psychological challenges like anxiety and depression. Ashwagandha, a traditional adaptogen, is believed to reduce stress and improve hair and skin quality, but more scientific evidence is needed to confirm these benefits. Participants will be randomly assigned to receive either the active treatment of KSM-66 Ashwagandha capsules (300 mg) or a placebo capsule twice daily after meals for about 90 days. The study uses a double-blind design, meaning neither the participants nor the researchers know who receives which capsule. The treatment aims to evaluate parameters such as skin hydration, elasticity, barrier function, hair density, strength, and growth. During the study, participants will undergo various assessments including dermatological exams, questionnaires on quality of life related to hair and skin, and instrumental measurements of skin and hair characteristics at the start and after 12 weeks. Safety will also be monitored throughout. The main outcome measured is the change in skin water loss, with additional assessments of hair density, diameter, growth rate, and user-reported quality of life and self-assessments. Participants must follow specific guidelines such as not cutting hair and avoiding medications during the trial.
CONDITIONS
Brief Title
Effects of KSM-66 Ashwagandha® (300 mg) on Skin and Hair Health in Healthy Men and Women"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy men and women aged 18 to 60 years
- Willing to follow study protocol and provide written informed consent
- Consistent use of dietary, hair, and skin products for 3 months before study and willing to maintain during the study
- Agree not to use any medications, vitamins, or minerals during or before the study
- Mild to moderate hair loss (Norwood-Hamilton type II-V in males; Ludwig type I-II in females)
- Willing to attend all follow-up visits
- Agree not to cut hair during the study
- Willing to undergo Trichoscan evaluation and avoid washing hair 48 hours before visits
- Agree to take the investigational product for 90 ± 4 days
You will not qualify if you...
- History of significant medical or psychiatric conditions that could affect safety or study results
- Use of hair loss medications or supplements in the 3 months before study (e.g., finasteride, minoxidil, steroids)
- Known allergies or hypersensitivity to study medication
- Planned or past hair transplantation during the study period
- Presence of facial skin cancer
- Skin conditions like sunburn, uneven skin tone, tattoos, scars, dilated vessels affecting test areas
- Severe seborrheic dermatitis, alopecic diseases other than androgenic alopecia, scalp psoriasis, or infections
- Participation in another clinical study in the last 180 days
- Eating disorders such as bulimia or psychogenic eating disorders
- Pregnant or breastfeeding women
- Alcohol addiction or ongoing drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 ± 4 days
Participants take KSM-66 Ashwagandha® or placebo capsules orally twice daily after food for the study duration while undergoing assessments related to skin and hair health.
Baseline visit and follow-up visits up to Week 12
Trial Site Locations
Total: 1 location
1
San Francisco Research Institute
San Francisco, California, United States, 94132
Actively Recruiting
Research Team
D
Dr. John Ademola
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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