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

Part of paid clinical trials in San Francisco, California.

Sponsor
SF Research Institute, Inc.
Study ID
NCT07441070
Status
Recruiting
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Conditions

  • Anxiety
  • Minority Stress
  • Psychological Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 29, 2026
Status verified
Apr 2026
Primary completion
Jul 30, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Placebo Comparator: Placebo (Inactive capsule)
    Participants will receive identical placebo capsules containing starch, taken orally twice daily for 8 weeks.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Research InstituteSan FranciscoCalifornia94132
Khaleeq Rehman
[email protected]
415-690-9641

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By research site
San Francisco Research Institute· San Francisco, CA

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