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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress Scale (PSS-10) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Ashwagandha Root Extract
Participants will receive Ashwagandha (Withania somnifera) root extract capsules at a dose of 300 mg taken orally twice daily for 8 weeks.
干预措施: Ashwagandha Root Extract (Dietary Supplement)
Placebo (Inactive capsule)
Participants will receive identical placebo capsules containing starch, taken orally twice daily for 8 weeks.
干预措施: Placebo Capsule (Other)
结局指标
主要结局
Change in Perceived Stress Scale (PSS-10) Score
时间窗: Baseline, Week 4, and Week 8
The Perceived Stress Scale (PSS-10) is a validated 10-item self-reported questionnaire that measures perceived stress over the previous month. Each item is scored from 0 (never) to 4 (very often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (worse outcome). This outcome measures the mean change from baseline in PSS-10 total score, where a reduction in score indicates improvement in perceived stress.
次要结局
- Change in Depression Anxiety Stress Scale (DASS-21) Scores(Baseline, Week 4, and Week 8)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, Week 4, and Week 8)
- Change in Minority Stress Measured by DHEQ-S-12(Baseline, Week 4, and Week 8)
- Change in Quality of Life Measured by WHOQOL-BREF(Baseline, Week 4, and Week 8)
- Change in Profile of Mood States (POMS) Score(Baseline, Week 4, and Week 8)
- Change in Salivary Cortisol Awakening Response(Baseline and Week 8)
- Change in Bedtime Salivary Cortisol Level(Baseline and Week 8)
- Incidence of Treatment-Emergent Adverse Events(Baseline, Week 4, and Week 8)
- Incidence of Treatment-Emergent Serious Adverse Events(Baseline, Week 4, and Week 8)