NCT07441070 · SF Research Institute, Inc.
Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
What this study is about
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.
View original scientific description
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.
Interventions
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
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.
Primary outcome measures
Change in Perceived Stress Scale (PSS-10) Score
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Where
- San Francisco, California
Collaborators
Ixoreal Biomed Private Limited
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations