Ashwagandha for stress, anxiety, and sleep in sexual and gender minority adults
Efficacy and Safety of Ashwagandha (Withania Somnifera) Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress: A Randomized, Double-Blind, Placebo-Controlled Study
This 8-week test will see if taking Ashwagandha root extract twice daily can reduce stress and anxiety and improve sleep in sexual and gender minority adults aged 18–45 who report moderate to high perceived stress.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | SF Research Institute, Inc. Research network |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07441070 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, double-blind, placebo-controlled trial enrolling 80 adults who self-identify as sexual or gender minorities and report moderate to high perceived stress. Participants are randomized 1:1 to receive Ashwagandha root extract 300 mg twice daily or an identical placebo for 8 weeks. Assessments occur at baseline, Week 4, and Week 8 with the Perceived Stress Scale (PSS-10) as the primary outcome and secondary measures including anxiety, mood, sleep quality, quality of life, minority stress experiences, and salivary cortisol. Safety and tolerability are monitored throughout the intervention period.
Who should consider this trial
Good fit: Ideal candidates are adults 18–45 who self-identify as sexual or gender minorities, have moderate to high perceived stress (PSS-10 > 14), and are not using anti-anxiety or sleep medications.
Not a fit: People with current psychiatric diagnoses, recent use of anxiolytics or sleep aids (including cannabis or melatonin), known Ashwagandha allergy, or certain chronic illnesses are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could provide a safe, non-prescription herbal option to reduce stress and improve anxiety and sleep for sexual and gender minority adults.
How similar studies have performed: Previous randomized trials in generally stressed adult populations have shown reductions in perceived stress, anxiety, and cortisol with Ashwagandha, but it has not been specifically tested in those experiencing minority stress.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
San Francisco, California
- San Francisco Research Institute — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Dr. John Ademola
- Email: jademola@sfinstitute.com
- Phone: 415-845-4638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.