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Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress

SF Research Institute, Inc. · with Ixoreal Biomed Private Limited · NCT07441070

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
80
US sites recruiting
1
Study start
April 29, 2026
Record last updated
April 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Ashwagandha Root Extract; Placebo Capsule

Conditions: Minority Stress; Psychological Stress; Anxiety

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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

Exclusion Criteria

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

Recruiting US locations

  • San Francisco Research Institute

    San Francisco, CA 94132

    Site contact: Khaleeq Rehman · 415-690-9641 · khaleeqr.sfinstitute@gmail.com

Study contacts (from the official record)

  • Dr. John Ademola · 415-845-4638 · jademola@sfinstitute.com
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Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep… (NCT07441070) | Bored Studies