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

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

Overview

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.

Detailed 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 stress responses, reduce cortisol levels, and improve psychological well-being and sleep in stressed adults. However, its effects have not been specifically evaluated in individuals experiencing minority stress.

This is a single-center, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of Ashwagandha root extract in adults experiencing minority stress. Eighty eligible participants will be randomized in a 1:1 ratio to receive either Ashwagandha root extract (300 mg capsules taken orally twice daily) or an identical placebo for a duration of 8 weeks.

Study assessments will be conducted at baseline, Week 4, and Week 8. Primary efficacy will be evaluated using the Perceived Stress Scale (PSS-10). Secondary outcomes include measures of anxiety, mood, sleep quality, quality of life, minority stress experiences, and salivary cortisol levels. Safety will be assessed through systematic recording of treatment-emergent adverse events and serious adverse events.

The results of this study will provide clinical evidence regarding the role of Ashwagandha supplementation as a supportive intervention for stress, anxiety, and sleep disturbances in sexual and gender minority adults.

Interventions

• Dietary supplement Ashwagandha 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.
• Other Placebo 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.

Primary outcome measures

• Change in Perceived Stress Scale (PSS-10) Score [Time frame: Baseline, Week 4, and Week 8]

Secondary outcome measures (9)

• Change in Depression Anxiety Stress Scale (DASS-21) Scores [Time frame: Baseline, Week 4, and Week 8]
• Change in Pittsburgh Sleep Quality Index (PSQI) Score [Time frame: Baseline, Week 4, and Week 8]
• Change in Minority Stress Measured by DHEQ-S-12 [Time frame: Baseline, Week 4, and Week 8]
• Change in Quality of Life Measured by WHOQOL-BREF [Time frame: Baseline, Week 4, and Week 8]
• Change in Profile of Mood States (POMS) Score [Time frame: Baseline, Week 4, and Week 8]
• Change in Salivary Cortisol Awakening Response [Time frame: Baseline and Week 8]
• Change in Bedtime Salivary Cortisol Level [Time frame: Baseline and Week 8]
• Incidence of Treatment-Emergent Adverse Events [Time frame: Baseline, Week 4, and Week 8]
• Incidence of Treatment-Emergent Serious Adverse Events [Time frame: Baseline, Week 4, and Week 8]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• San Francisco Research Institute — San Francisco

Identifiers

NCT: NCT07441070 · Ixo/2025/1201/ARE/LGBTQ/SF/01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗