Clinical trial Recruiting at 1 site Interventional Ages 18 to 45

Ashwagandha for stress, anxiety, and sleep in sexual and gender minority adults

Official title: 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

Run by SF Research Institute, Inc. · NCT07441070 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years to 45 Years
SexAll
Enrollment80 (estimated)
SponsorSF Research Institute, Inc.
Research network
Locations1 site (San Francisco, California)
StatusRecruiting
StartedApril 29, 2026
Main results expectedJuly 30, 2026
Study endsAugust 15, 2026
Registry record updatedApril 27, 2026
Trial IDNCT07441070 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • San Francisco Research Institute
    San Francisco, California, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.