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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• San Francisco Research Institute — San Francisco

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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