Skin HealthNCT07215689
Effects of KSM-66 Ashwagandha® (300 mg) on Skin and Hair Health in Healthy Men and Women"
A study testing KSM-66 Ashwagandha® capsule in people with Skin Health and Hair Health, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Health, Hair Health
- What is being tested?
- KSM-66 Ashwagandha® capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Research Institute
San Francisco, California, 94132
Komal Makwana, komalk.sfinstitute@gmail.com
About this study
Official title: 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
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.
Read the 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
- Being tested
- KSM-66 Ashwagandha® capsule, Placebo Capsule(s)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSM-66 Ashwagandha® capsuleDietary 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Capsule(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, Week 12
Secondary outcomes (9)
Change in Hair Density (n/cm²)
To evaluate the effect of KSM-66 Ashwagandha on hair density from Baseline (Day 1) to Week 12 using Trichoscan analysis.
Measured: 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).
To evaluate the efficacy of KSM-66 Ashwagandha formulation on skin health in terms of quality of life using the Dermatology Life Quality Index (DLQI) questionnaire.
Measurement Scale:
DLQI total score ranges from 0 to 30, where
0-1: No effect on patient's life,
2-5: Small effect,
6-10: Moderate effect,
11-20: Very large effect,
21-30: Extremely large effect. Lower scores indicate better dermatological quality of life (i.e., improvement).
Measured: 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
To evaluate the efficacy of KSM-66 Ashwagandha formulation on hair health using the Hair Skindex-29 Questionnaire.
Measurement Scale:
The Hair Skindex-29 is a validated 29-item questionnaire assessing the effects of hair conditions on quality of life, with a total score range of 0-100.
Higher scores represent worse quality of life, while lower scores indicate improvement.
Measured: 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
To evaluate the participant's perceived improvement in hair and skin health using a 5-point Likert scale.
Measurement Scale:
Scores range from 1 to 5, where
- = Very much worse,
- = Worse,
- = No change,
- = Improved,
- = Very much improved. Higher scores indicate better improvement as perceived by the participant.
Measured: Baseline, Week 12
To evaluate the effects of KSM-66 Ashwagandha formulation on hair and skin in terms of physician's global assessment
To evaluate the investigator's overall assessment of improvement in hair and skin health using the Global Physician Assessment scale.
Measurement Scale:
A 5-point Likert scale, where
- = Very much worse,
- = Worse,
- = No change,
- = Improved,
- = Very much improved. Higher scores indicate better improvement as assessed by the physician.
Measured: Baseline, Week 12
Change in Hair Diameter (µm)
To evaluate the effect of KSM-66 Ashwagandha on mean hair diameter from Baseline (Day 1) to Week 12 using Trichoscan analysis.
Measured: Baseline, Week 12
To evaluate the safety of KSM-66 Ashwagandha formulation in healthy men and women
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE)
Measured: Baseline, Week 12
Change in Hair Growth Rate (mm/day)
To assess the change in average hair growth rate from Baseline (Day 1) to Week 12 using Trichoscan analysis.
Measured: Baseline, Week 12
Change in Anagen/Telogen Ratio
To evaluate changes in the Anagen/Telogen ratio as an indicator of hair growth phase balance from Baseline (Day 1) to Week 12 using Trichoscan analysis.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start11 Jul 2025
- Primary completion22 Nov 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215689
- Sponsor's protocol ID
- Ixoreal-HS-CT-05-22
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07215689
- Acronym / sponsor ID
- Ixoreal-HS-CT-05-22
- Conditions
- Skin Health, Hair Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 22 Nov 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg) | Active comparator | Dietary Supplement: KSM-66 Ashwagandha® capsuleKSM-66 Ashwagandha® capsule (300 mg) orally twice daily after food with a glass of water or milk for 90 ± 4 days. |
| Treatment Arm 2: Identical placebo capsule | Placebo comparator | Other: Placebo Capsule(s)Placebo capsule containing starch (300 mg) orally twice daily after food with a glass of water or milk for 90 ± 4 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSM-66 Ashwagandha® capsuleSingle off-white capsule contains 300mg Ashwagandha root extract powder only | Dietary supplement | Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg) |
| Placebo Capsule(s)Single off-white capsule contains starch powder only | Other | Treatment Arm 2: Identical placebo capsule |
Primary outcome
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
Mean change in TEWL from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Week 12)
9 secondary outcomes
Change in Hair Density (n/cm²)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 12
To evaluate the effects of KSM-66 Ashwagandha formulation on hair and skin in terms of physician's global assessment
Time frame: Baseline, Week 12
Change in Hair Diameter (µm)
Time frame: Baseline, Week 12
To evaluate the safety of KSM-66 Ashwagandha formulation in healthy men and women
Time frame: Baseline, Week 12
Change in Hair Growth Rate (mm/day)
Time frame: Baseline, Week 12
Change in Anagen/Telogen Ratio
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KSM-66 Ashwagandha® capsule in people with Skin Health and Hair Health, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. John Ademola (415-845-4638, jademola@sfinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.