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NCT07441070 · ClinicalTrials.gov registry record · NA
Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
A NA study, sponsored by SF Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT07441070: Recruiting NA study, sponsored by SF Research Institute.
NCT07441070 is a NA study that is actively recruiting participants, run by SF Research Institute. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07441070, a NA study, is actively recruiting participants, sponsored by SF Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Placebo Capsule
- DIETARY_SUPPLEMENT Ashwagandha Root Extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-04-29 |
| Est. Completion | 2026-08-15 |
| Phase | NA |
What NCT07441070 shows while recruiting
NCT07441070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Capsule is the first listed.
NCT07441070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07441070 about?
NCT07441070 is a clinical study titled "Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress". 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 quali...
What is the current status of trial NCT07441070?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2026-04-29. Estimated completion is 2026-08-15.
What interventions are being tested in trial NCT07441070?
The interventions under investigation include: Placebo Capsule (OTHER), Ashwagandha Root Extract (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07441070?
This trial is sponsored by SF Research Institute, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07441070's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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