Recruiting

Ashwagandha

Sponsor:

SF Research Institute, Inc.

Code:

NCT07441070

Conditions

Minority Stress

Psychological Stress

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Ashwagandha Root Extract

Placebo Capsule

Study Details

Brief summary:

Sexual and gender minority adults often experience elevated levels of chronic stress due to stigma, discrimination, and social adversity, commonly referred to as minority stress. This persistent stress is associated with increased anxiety, mood disturbances, impaired sleep quality, and reduced quality of life. There is a need for safe, non-pharmacological interventions that can support mental well-being in this population.

This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Ashwagandha (Withania somnifera) root extract in reducing stress and improving anxiety and sleep quality in adults experiencing minority stress. A total of 80 adults aged 18 to 45 years who self-identify as sexual or gender minorities and report moderate to high perceived stress will be enrolled.

Participants will be randomly assigned to receive either Ashwagandha root extract (300 mg capsules taken twice daily) or an identical placebo for 8 weeks. Efficacy will be assessed using validated psychological and quality-of-life questionnaires, including the Perceived Stress Scale, Depression Anxiety Stress Scale, Pittsburgh Sleep Quality Index, and other mood and minority stress measures. Salivary cortisol will be measured as a biological marker of stress. Safety will be evaluated through monitoring of adverse events throughout the study.

Conditions

Minority Stress

Psychological Stress

Anxiety

Study ID

NCT07441070

Start date

Apr 29, 2026

Status verified date

Apr, 2026

Completion date

Aug 15, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Self-identified as a sexual or gender minority (e.g., lesbian, gay, bisexual, transgender, queer, non-binary).
2. Aged 18-45 years.
3. Moderate to high perceived stress levels (PSS-10 total score >14).
4. Willing to provide written informed consent.

Exclusion Criteria:

1. Current psychiatric diagnosis (e.g., major depressive disorder, bipolar disorder, psychosis).
2. Use of anti-anxiety or sleep medication (including sleep aids, cannabis or melatonin) in the last 3 months.
3. Known allergy or intolerance to Ashwagandha.
4. Any chronic illness that may confound the results (e.g., known liver illness, severe insomnia, or neurological disorders).

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ashwagandha Root Extract

Participants will receive Ashwagandha (Withania somnifera) root extract capsules at a dose of 300 mg taken orally twice daily for 8 weeks.

placebo comparator: Placebo (Inactive capsule)

Participants will receive identical placebo capsules containing starch, taken orally twice daily for 8 weeks.

Interventions

Ashwagandha Root Extract

Ashwagandha (Withania somnifera) root extract is a standardized herbal dietary supplement formulated as oral capsules containing 300 mg of extract. Participants will take two capsules daily, one in the morning and one in the evening, for 8 weeks.

Placebo Capsule

The placebo consists of an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take two capsules daily for 8 weeks.

Primary outcome measure

  • Change in Perceived Stress Scale (PSS-10) Score [ Time Frame: Baseline, Week 4, and Week 8 ]

Central Contacts and Locations

Central contacts

Locations

San Francisco Research Institute

Recruiting

San Francisco, California, United States, 94132

Contacts

More Information

Sponsor

SF Research Institute, Inc.

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • Ashwagandha
  • LGBTQ health
  • Withania somnifera

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SF Research Institute, Inc. on 2026-04-27.