Ashwagandha for Minority Stress

Overseen By Dr. John Ademola

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: SF Research Institute, Inc.

Must not be taking: Anti-anxiety, Sleep aids

Disqualifiers: Psychiatric diagnosis, Liver illness, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

Self-identified as a sexual or gender minority (e.g., lesbian, gay, bisexual, transgender, queer, non-binary)

Moderate to high perceived stress levels (PSS-10 total score >14)

I am between 18 and 45 years old.

Exclusion Criteria

I have used medication for anxiety or sleep in the past 3 months.

Current psychiatric diagnosis (e.g., major depressive disorder, bipolar disorder, psychosis)

Known allergy or intolerance to Ashwagandha

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ashwagandha root extract or placebo for 8 weeks

8 weeks

3 visits (in-person) at Baseline, Week 4, and Week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ashwagandha Root Extract

How Is the Trial Designed?

Group I: Ashwagandha Root Extract Experimental Treatment 1 Intervention

Participants will receive Ashwagandha (Withania somnifera) root extract capsules at a dose of 300 mg taken orally twice daily for 8 weeks.

Group II: Placebo (Inactive capsule) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

SF Research Institute, Inc.

Lead Sponsor

Trials

7

Recruited

540+

Ixoreal Biomed Private Limited

Industry Sponsor