NCT07441070 Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
| NCT ID | NCT07441070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SF Research Institute, Inc. |
| Condition | Minority Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-04-29 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07441070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Minority Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07441070 currently recruiting?
Yes, NCT07441070 is actively recruiting participants. Contact the research team at jademola@sfinstitute.com for enrollment information.
Where is the NCT07441070 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07441070 clinical trial?
NCT07441070 is sponsored by SF Research Institute, Inc.. The trial plans to enroll 80 participants.