Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSF Research Institute, Inc.
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Ashwagandha Root Extract
Dietary supplementAshwagandha (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.
Placebo Capsule
Other interventionThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Ashwagandha Root ExtractExperimental treatment 1 intervention
Group B: Placebo (Inactive capsule)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Perceived Stress Scale (PSS-10) Score
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.
Time frame
Baseline, Week 4, and Week 8Secondary outcomes
1
Change in Depression Anxiety Stress Scale (DASS-21) Scores
The Depression Anxiety Stress Scale-21 (DASS-21) is a validated 21-item questionnaire assessing symptoms of depression, anxiety, and stress. Each item is scored from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Each subscale score (Depression, Anxiety, Stress) ranges from 0 to 21, and the total score ranges from 0 to 63. Higher scores indicate greater symptom severity (worse outcome). This outcome measures the mean change from baseline in DASS-21 total and subscale scores, where a reduction in score indicates improvement in psychological symptoms.
Time frame
Baseline, Week 4, and Week 82
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a validated questionnaire assessing subjective sleep quality and disturbances over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome). This outcome measures the mean change from baseline in PSQI global score, where a reduction in score indicates improvement in sleep quality.
Time frame
Baseline, Week 4, and Week 83
Change in Minority Stress Measured by DHEQ-S-12
The Daily Heterosexist Experiences Questionnaire - Short Form (DHEQ-S-12) is a validated 12-item instrument assessing experiences of minority stress. Each item is scored from 0 to 5. The total score ranges from 0 to 60, with higher scores indicating greater minority stress experiences (worse outcome). This outcome measures the mean change from baseline in DHEQ-S-12 total score, where a reduction in score indicates improvement in minority stress experiences.
Time frame
Baseline, Week 4, and Week 84
Change in Quality of Life Measured by WHOQOL-BREF
The WHOQOL-BREF is a validated 26-item questionnaire assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life (better outcome). This outcome measures the mean change from baseline in WHOQOL-BREF domain scores, where an increase in score indicates improvement in quality of life.
Time frame
Baseline, Week 4, and Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SF Research Institute, Inc.
Lead sponsor
Ixoreal Biomed Private Limited
Collaborator
Source ClinicalTrials.gov