NCT07215689

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: SF Research Institute, Inc. · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Skin Health
• Hair Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	KSM-66 Ashwagandha® capsule	Single off-white capsule contains 300mg Ashwagandha root extract powder only
OTHER	Placebo Capsule(s)	Single off-white capsule contains starch powder only

Timeline

• Start date: 2025-07-11
• Primary completion: 2025-11-22
• Completion: 2025-12-10
• First posted: 2025-10-10
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States