KSM-66 Ashwagandha for Skin and Hair Health

Overseen By Dr. John Ademola

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: SF Research Institute, Inc.

Must not be taking: Hair loss treatments

Disqualifiers: Rosacea, Eczema, Psoriasis, Atopic dermatitis, others

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether KSM-66 Ashwagandha, a natural supplement, can improve hair and skin health. Researchers aim to determine if the supplement can help manage hair loss and skin issues often caused by stress. The trial includes two groups: one taking Ashwagandha capsules and another taking placebo capsules. Ideal participants are those experiencing mild to moderate hair loss, who have not changed their hair or skin routine in the past three months, and are willing to maintain their current routine throughout the study. As an unphased trial, this study provides an opportunity to explore the potential benefits of a natural supplement for hair and skin health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications, including prescription, over-the-counter, vitamins, and minerals, before and during the study.

Is there any evidence suggesting that KSM-66 Ashwagandha® is likely to be safe for humans?

Research has shown that KSM-66 Ashwagandha® is generally safe. People taking Ashwagandha typically experience only mild side effects, similar to those of a placebo. Importantly, these studies have found no serious side effects.

Ashwagandha's long history in traditional medicine further supports its safety. However, while it is considered safe for up to three months, little is known about its long-term effects. This suggests it might be safe for short-term use, but more research is needed to understand its effects over longer periods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

KSM-66 Ashwagandha® is unique because it harnesses the power of a natural herb, ashwagandha, known for its adaptogenic properties, which help the body manage stress. Most treatments for skin and hair health focus on topical applications or supplements that target specific deficiencies. However, KSM-66 Ashwagandha® works differently by potentially improving overall well-being and reducing stress, which can indirectly benefit skin and hair health. Researchers are excited about this treatment because it offers a holistic approach, possibly addressing the root causes of skin and hair issues rather than just the symptoms.

What evidence suggests that KSM-66 Ashwagandha® might be an effective treatment for hair and skin health?

Studies have shown that KSM-66 Ashwagandha, which participants in this trial may receive, can improve hair and skin health. Research suggests that Ashwagandha may lower stress and cortisol levels, potentially preventing inflammation that leads to hair loss. In one study, people using Ashwagandha experienced noticeably less hair shedding. The extract also contains antioxidants and amino acids that might strengthen hair and reduce breakage. Additionally, Ashwagandha may enhance skin health by boosting its glow and vitality. These findings suggest that Ashwagandha could be a promising natural choice for improving hair and skin wellness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy men and women interested in improving their skin and hair health. Participants should be looking for natural treatment options but have no specific details on eligibility criteria provided.

Inclusion Criteria

Willingness to follow the protocol requirements as evidenced by written informed consent

Willing to come for all follow-up visits

Participants who agree to take investigational product (i.e., Till Day 90 ± 4 ± 4)

Exclusion Criteria

Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to study medication)

Participants who have participated in a clinical study during the preceding 180 days

Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive KSM-66 Ashwagandha or placebo capsules twice daily for 90 days

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• KSM-66 Ashwagandha®

Trial Overview

The study tests KSM-66 Ashwagandha® (300 mg) capsules against placebo capsules to see if they improve skin and hair health, potentially by reducing stress-related damage.

How Is the Trial Designed?

Group I: Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg) Active Control 1 Intervention

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

Group II: Treatment Arm 2: Identical placebo capsule Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

SF Research Institute, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07215689

Effects of KSM-66 Ashwagandha® (300 mg) on Skin and ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10709127/

Effects of Withania somnifera root extract serum application ...

In the per protocol analysis of 61 participants, Ashwagandha group demonstrated significant reduction in hair shedding in the 60 Seconds Hair ...

3.

trialx.com

trialx.com/clinical-trials/listings/312093/effects-of-ksm-66-ashwagandha-300-mg-on-skin-and-hair-health-in-healthy-men-and-women/

Effects of KSM-66 Ashwagandha® (300 mg) on Skin and ...

Ashwagandha also contains antioxidants and amino acids that may strengthen the hair and minimize breakage. Traditionally, Ashwagandha has been ...

4.

ksm66ashwagandhaa.com

ksm66ashwagandhaa.com/science.php

Science

Conclusion: The study demonstrated that Ashwagandha root extract (250 mg/day and 600 mg/day) significantly reduced stress, anxiety, and serum cortisol levels, ...

5.

cosmeticsdesign.com

cosmeticsdesign.com/Headlines/Promotional-features/clinically-studied-ksm-66-ashwagandha-supports-skin-and-hair-health/

Clinically-studied KSM-66 Ashwagandha supports skin ...

From reducing cortisol to increasing skin radiance and hair vitality, science-backed ashwagandha bridges inner wellness and outer beauty.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3573577/

A Prospective, Randomized Double-Blind, Placebo-Controlled ...

An analysis of the adverse events recorded in this study indicates that high-concentration full-spectrum Ashwagandha root extract is safe and well tolerated as ...

7.

webmd.com

webmd.com/vitamins/ai/ingredientmono-953/ashwagandha

Ashwagandha - Uses, Side Effects, and More

When taken by mouth: Ashwagandha is possibly safe when used for up to 3 months. The long-term safety of ashwagandha is not known. Large doses of ashwagandha ...

8.

ayush.gov.in

ayush.gov.in/images/domains/quality_standards/safetyReportAshwagandha.pdf

Safety of Ashwagandha

Ashwagandha root extract is safe, and well tolerated by all the participants. Personal Care / Hair and Skin Health. Healthy Skin in Adults ...