Actively Recruiting
Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
Led by SF Research Institute, Inc. · Updated on 2026-04-27
80
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
Sponsors
S
SF Research Institute, Inc.
Lead Sponsor
I
Ixoreal Biomed Private Limited
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identified as a sexual or gender minority (e.g., lesbian, gay, bisexual, transgender, queer, non-binary).
- Aged 18 to 45 years.
- Moderate to high perceived stress levels (Perceived Stress Scale total score over 14).
- Willing to provide written informed consent.
You will not qualify if you...
- Current psychiatric diagnosis such as major depressive disorder, bipolar disorder, or psychosis.
- Use of anti-anxiety or sleep medications, including sleep aids, cannabis, or melatonin, within the last 3 months.
- Known allergy or intolerance to Ashwagandha.
- Any chronic illness that may affect the study results, including liver disease, severe insomnia, or neurological disorders.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
San Francisco Research Institute
San Francisco, California, United States, 94132
Actively Recruiting
Research Team
D
Dr. John Ademola
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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