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
SF Research Institute, Inc.
Summary
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.
Description
Minority stress is a well-established contributor to mental health disparities among sexual and gender minority populations. Chronic exposure to stigma, discrimination, and social rejection activates stress-related neuroendocrine pathways, including dysregulation of the hypothalamic-pituitary-adrenal axis, leading to sustained elevations in cortisol and adverse psychological outcomes such as anxiety, mood disturbances, and poor sleep quality. Ashwagandha (Withania somnifera) is a traditional Ayurvedic medicinal herb recognized for its adaptogenic properties. It has been shown to modulate stre…
Eligibility
- Age range
- 18–45 years
- Sex
- All
- Healthy volunteers
- Yes
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 re…
Interventions
- Dietary SupplementAshwagandha Root Extract
Ashwagandha (Withania somnifera) root extract is a standardized herbal dietary supplement formulated as oral capsules containing 300 mg of extract. Participants will take two capsules daily, one in the morning and one in the evening, for 8 weeks.
- OtherPlacebo Capsule
The placebo consists of an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take two capsules daily for 8 weeks.
Location
- San Francisco Research InstituteSan Francisco, California