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

NCT07441070 | Recruiting

• 1 other identifier: Ixo/2025/1201/ARE/LGBTQ/SF/01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Minority Stress; Psychological Stress; Anxiety

Keywords

Ashwagandha; LGBTQ health; Withania somnifera

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Ashwagandha Root Extract

EXPERIMENTAL

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

Placebo (Inactive capsule)

PLACEBO COMPARATOR

Participants will receive identical placebo capsules containing starch, taken orally twice daily for 8 weeks.

Other: Placebo Capsule

Interventions

Ashwagandha Root Extract DIETARY_SUPPLEMENT

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.

Also known as: ARE

Ashwagandha Root Extract

Placebo Capsule OTHER

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.

Placebo (Inactive capsule)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Ixoreal Biomed Private Limited: collaborator

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

RECRUITING

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Dr. John Ademola

CONTACT

415-845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)