Actively Recruiting
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
Led by SF Research Institute, Inc. · Updated on 2026-04-27
80
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
Sponsors
S
SF Research Institute, Inc.
Lead Sponsor
I
Ixoreal Biomed Private Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sexual and gender minority adults often face ongoing stress from stigma and discrimination, which can lead to anxiety, mood issues, poor sleep, and reduced quality of life. Researchers are studying whether Ashwagandha root extract can help reduce stress and improve anxiety and sleep quality in this group. This randomized, double-blind, placebo-controlled study involves 80 adults aged 18 to 45 years who report moderate to high stress levels. Participants will be randomly assigned to receive either 300 mg of Ashwagandha root extract capsules twice daily or identical placebo capsules for 8 weeks. The study involves two groups: one taking Ashwagandha capsules and the other taking placebo capsules. Assessments will occur at baseline, Week 4, and Week 8 to compare effects over time. During the study, participants will complete questionnaires measuring stress, anxiety, mood, sleep quality, minority stress experiences, and quality of life. Salivary cortisol samples will be collected as a biological stress marker. Safety will be monitored by tracking adverse events throughout the 8-week treatment period. The primary outcome is change in perceived stress, with multiple secondary outcomes assessed to understand broader effects.
CONDITIONS
Brief Title
Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identified as a sexual or gender minority (e.g., lesbian, gay, bisexual, transgender, queer, non-binary).
- Aged 18 to 45 years.
- Moderate to high perceived stress levels (Perceived Stress Scale total score >14).
- Willing to provide written informed consent.
You will not qualify if you...
- 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 affect the results (e.g., liver illness, severe insomnia, neurological disorders).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take Ashwagandha root extract or placebo capsules orally twice daily for 8 weeks to evaluate effects on stress, anxiety, and sleep quality.
3 visits (baseline, Week 4, and Week 8)
Trial Site Locations
Total: 1 location
1
San Francisco Research Institute
San Francisco, California, United States, 94132
Actively Recruiting
Research Team
D
Dr. John Ademola
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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