Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT07215689

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

Led by SF Research Institute, Inc. · Updated on 2025-10-15

50

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adult men and women aged 18 to 60 years
  • Willingness to follow protocol requirements with written informed consent
  • On consistent dietary, hair, and skin products for 3 months before study and willing to continue same
  • Agree not to use any medication, vitamins, or minerals before or during the study
  • Mild to moderate hair loss as Norwood-Hamilton type II-V in males or 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 not wash hair 48 hours before visits
  • Participants or legal authorized representatives able and willing to give informed consent
  • Agree to take investigational product until Day 90 ± 4 days
Not Eligible

You will not qualify if you...

  • Clinically significant medical history or conditions such as rosacea, eczema, psoriasis, atopic dermatitis, or ongoing medical or psychiatric conditions that could affect safety or study validity
  • Use of hair loss medications or supplements like finasteride, minoxidil, steroids, or hormonal products within 3 months prior to study
  • History of allergic or hypersensitivity reactions to study medication
  • Hair transplantation surgery planned or performed during study period
  • Facial skin cancer
  • Sunburn, moderate to severe suntan, uneven skin tones, tattoos, scars, dilated vessels, or other conditions on test area affecting results
  • Severe seborrheic dermatitis, alopecic diseases except androgenic alopecia, scalp psoriasis, or infections
  • Participation in another clinical study within 180 days prior
  • Eating disorders such as bulimia or psychogenic eating disorders
  • Pregnant or lactating females
  • Alcohol addiction or persistent abuse of drugs of dependence

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

San Francisco Research Institute

San Francisco, California, United States, 94132

Actively Recruiting

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Research Team

D

Dr. John Ademola

CONTACT

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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