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
SF Research Institute, Inc.
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 lifestyles. Effective and time-efficient treatments for hair and skin health remain limited. Although hair loss, baldness, and skin issues are not life-threatening, managing these conditions is important because of the psychological and social complications-such as anxiety and depression-they can cause. There is an unmet need for therapies that provide safe and long-term improvements in hair and skin health. Many individuals seek Complementary and Alternative Medicine (CAM) to identify natural and effective options for these conditions. Adaptogens such as Ashwagandha (Withania somnifera) have long been studied for their potential to reduce stress and modulate cortisol levels in the body. Reducing stress may help prevent inflammation, a common contributor to hair shedding and loss. Ashwagandha also contains antioxidants and amino acids that may strengthen the hair and minimize breakage. Traditionally, Ashwagandha has been recognized for its multiple health benefits, including support for hair and skin wellness. However, there remains limited scientific evidence to substantiate these traditional claims, underscoring the need for controlled clinical evaluation.
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 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…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- Dietary SupplementKSM-66 Ashwagandha® capsule
Single off-white capsule contains 300mg Ashwagandha root extract powder only
- OtherPlacebo Capsule(s)
Single off-white capsule contains starch powder only
Location
- San Francisco Research InstituteSan Francisco, California