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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Psychological Stress; Minority Stress
• Intervention / Treatment: Dietary supplement: Ashwagandha Root Extract; Other: Placebo Capsule

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. John Ademola; Phone Number: 415-845-4638; Email: jademola@sfinstitute.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94132
      • Recruiting
      • San Francisco Research Institute
      • Contact: Khaleeq Rehman; Phone Number: 415-690-9641; Email: khaleeqr.sfinstitute@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 results (e.g., known liver illness, severe insomnia, or neurological disorders).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 Names: ARE
Placebo Comparator: Placebo (Inactive capsule); Participants will receive identical placebo capsules containing starch, taken orally twice daily 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress Scale (PSS-10) Score	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.	Baseline, Week 4, and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Salivary Cortisol Awakening Response	Change in cortisol awakening response measured using salivary cortisol samples.	Baseline and Week 8
Change in Bedtime Salivary Cortisol Level	Change in bedtime salivary cortisol as a biomarker of stress regulation.	Baseline and Week 8
Incidence of Treatment-Emergent Adverse Events	Number and proportion of participants experiencing treatment-emergent adverse events.	Baseline, Week 4, and Week 8
Incidence of Treatment-Emergent Serious Adverse Events	Number and proportion of participants experiencing treatment-emergent serious adverse events.	Baseline, Week 4, and Week 8
Change in Depression Anxiety Stress Scale (DASS-21) Scores	The Depression Anxiety Stress Scale-21 (DASS-21) is a validated 21-item questionnaire assessing symptoms of depression, anxiety, and stress. Each item is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Each subscale score (Depression, Anxiety, Stress) ranges from 0 to 21, and the total score ranges from 0 to 63. Higher scores indicate greater symptom severity (worse outcome). This outcome measures the mean change from baseline in DASS-21 total and subscale scores, where a reduction in score indicates improvement in psychological symptoms.	Baseline, Week 4, and Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) Score	The Pittsburgh Sleep Quality Index (PSQI) is a validated questionnaire assessing subjective sleep quality and disturbances over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome). This outcome measures the mean change from baseline in PSQI global score, where a reduction in score indicates improvement in sleep quality.	Baseline, Week 4, and Week 8
Change in Minority Stress Measured by DHEQ-S-12	The Daily Heterosexist Experiences Questionnaire - Short Form (DHEQ-S-12) is a validated 12-item instrument assessing experiences of minority stress. Each item is scored from 0 to 5. The total score ranges from 0 to 60, with higher scores indicating greater minority stress experiences (worse outcome). This outcome measures the mean change from baseline in DHEQ-S-12 total score, where a reduction in score indicates improvement in minority stress experiences.	Baseline, Week 4, and Week 8
Change in Quality of Life Measured by WHOQOL-BREF	The WHOQOL-BREF is a validated 26-item questionnaire assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life (better outcome). This outcome measures the mean change from baseline in WHOQOL-BREF domain scores, where an increase in score indicates improvement in quality of life.	Baseline, Week 4, and Week 8
Change in Profile of Mood States (POMS) Score	The Profile of Mood States (POMS) is a validated questionnaire assessing mood disturbance across six domains: tension, depression, anger, vigor, fatigue, and confusion. The Total Mood Disturbance (TMD) score typically ranges from -32 to 200 (depending on scoring method), with higher scores indicating greater mood disturbance (worse outcome). This outcome measures the mean change from baseline in POMS Total Mood Disturbance and subscale scores, where a reduction in TMD score indicates improvement in mood state.	Baseline, Week 4, and Week 8

Collaborators and Investigators

• Sponsor: SF Research Institute, Inc.
• Collaborators: Ixoreal Biomed Private Limited

Study record dates

Study Major Dates

• Study Start (Estimated): April 29, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ashwagandha; Withania somnifera; LGBTQ health
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Stress, Psychological
• Other Study ID Numbers: Ixo/2025/1201/ARE/LGBTQ/SF/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No