Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
Recruiting · NCT07441070 · Interventional (participants receive a specific treatment) · Lead sponsor: SF Research Institute, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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).
Where it is running
1 location listed across 1 US state.
- San Francisco Research Institute - San Francisco, California, United States