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

Conditions

• Hair Health
• Skin Health

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 11, 2025

Status verified

Oct 2025

Primary completion

Nov 22, 2025

Completion

Dec 10, 2025

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg)
  KSM-66 Ashwagandha® capsule (300 mg) orally twice daily after food with a glass of water or milk for 90 ± 4 days.
• Placebo Comparator: Treatment Arm 2: Identical placebo capsule
  Placebo capsule containing starch (300 mg) orally twice daily after food with a glass of water or milk for 90 ± 4 days.

Primary Outcome Measure

To evaluate the efficacy of KSM-66 Ashwagandha formulation on skin health in adult healthy men and women, in terms of TEWL (Trans Epidermal Water Loss) [ Time Frame: Baseline, Week 12 ]

Central Contacts

• Dr. John Ademola
  415-845-4638
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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