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

NCT07215689 | Recruiting

• 1 other identifier: Ixoreal-HS-CT-05-22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Health; Hair Health

Outcome Measures

Primary Outcomes (1)

• 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)

  Mean change in TEWL from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Week 12)

  Baseline, Week 12

Secondary Outcomes (9)

• Change in Hair Density (n/cm²)

  Baseline, Week 12

• To evaluate the efficacy of KSM-66 Ashwagandha formulation on skin health in terms of QoL for Skin using the Dermatology Life Quality Index (DLQI).

  Baseline, Week 12

• To evaluate the efficacy of KSM-66 Ashwagandha formulation on hair in terms of QoL for Hair using the Hair Skindex-29 Questionnaire

  Baseline, Week 12

• To evaluate the effects of KSM-66 Ashwagandha formulation on hair and skin in terms of self-assessment for skin and hair health

  Baseline, Week 12

• To evaluate the effects of KSM-66 Ashwagandha formulation on hair and skin in terms of physician's global assessment

  Baseline, Week 12

Study Arms (2)

Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg)

ACTIVE COMPARATOR

KSM-66 Ashwagandha® capsule (300 mg) orally twice daily after food with a glass of water or milk for 90 ± 4 days.

Dietary Supplement: KSM-66 Ashwagandha® capsule

Treatment Arm 2: Identical placebo capsule

PLACEBO COMPARATOR

Placebo capsule containing starch (300 mg) orally twice daily after food with a glass of water or milk for 90 ± 4 days.

Other: Placebo Capsule(s)

Interventions

KSM-66 Ashwagandha® capsule DIETARY_SUPPLEMENT

Single off-white capsule contains 300mg Ashwagandha root extract powder only

Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg)

Placebo Capsule(s) OTHER

Single off-white capsule contains starch powder only

Treatment Arm 2: Identical placebo capsule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult men and women participants ≥ 18 years and ≤60 years of age.
• Willingness to follow the protocol requirements as evidenced by written informed consent.
• 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.
• 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.
• Participants with mild to moderate hair loss classified as the Norwood-Hamilton type II, III, IV and V in males and Ludwig type I and II in females.
• Willing to come for all follow-up visits.
• Participants who agree not to cut hair for the entire duration of the study.
• Participants willing to undergo Trichoscan evaluation and not to wash their hair 48 hours before the visit.
• Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
• Participants who agree to take investigational product (i.e., Till Day 90 ± 4 ± 4).

You may not qualify if:

• Participants having any clinically significant medical history, medical finding including rosacea, eczema, psoriasis, and atopic dermatitis or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
• Participants on any medication or supplement for hair loss, including finasteride, any other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement.
• Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to study medication).
• Participants who have undergone or plan to undergo hair transplantation surgery during the study period.
• Participants with facial skin cancer.
• Participants with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos, scars or other disfiguration, dilated vessels or other conditions on the test area that might influence the test results.
• Participants with severe seborrheic dermatitis, alopecic disease, except for androgenic alopecia, and scalp disorders, such as scalp psoriasis and infection.
• Participants who have participated in a clinical study during the preceding 180 days.
• Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).
• Pregnant and lactating females
• Participants with alcohol addiction or persistent abuse of drugs of dependence.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

RECRUITING

Central Study Contacts

Dr. John Ademola

CONTACT

415-845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 10, 2025
• Study Start: July 11, 2025
• Primary Completion: November 22, 2025
• Study Completion: December 10, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)