Minority StressNCT07441070
Effect of Ashwagandha Root Extract on Stress, Anxiety, and Sleep Quality in Adults Experiencing Minority Stress
A study testing Ashwagandha Root Extract in people with Minority Stress and Psychological Stress, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Minority Stress, Psychological Stress, Anxiety
- What is being tested?
- Ashwagandha Root Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Research Institute
San Francisco, California, 94132
Khaleeq Rehman, 415-690-9641, khaleeqr.sfinstitute@gmail.com
About this study
Official title: 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
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.
Read the detailed description
Minority stress is a well-established contributor to mental health disparities among sexual and gender minority populations. Chronic exposure to stigma, discrimination, and social rejection activates stress-related neuroendocrine pathways, including dysregulation of the hypothalamic-pituitary-adrenal axis, leading to sustained elevations in cortisol and adverse psychological outcomes such as anxiety, mood disturbances, and poor sleep quality.
Ashwagandha (Withania somnifera) is a traditional Ayurvedic medicinal herb recognized for its adaptogenic properties. It has been shown to modulate stress responses, reduce cortisol levels, and improve psychological well-being and sleep in stressed adults. However, its effects have not been specifically evaluated in individuals experiencing minority stress.
This is a single-center, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of Ashwagandha root extract in adults experiencing minority stress. Eighty eligible participants will be randomized in a 1:1 ratio to receive either Ashwagandha root extract (300 mg capsules taken orally twice daily) or an identical placebo for a duration of 8 weeks.
Study assessments will be conducted at baseline, Week 4, and Week 8. Primary efficacy will be evaluated using the Perceived Stress Scale (PSS-10). Secondary outcomes include measures of anxiety, mood, sleep quality, quality of life, minority stress experiences, and salivary cortisol levels. Safety will be assessed through systematic recording of treatment-emergent adverse events and serious adverse events.
The results of this study will provide clinical evidence regarding the role of Ashwagandha supplementation as a supportive intervention for stress, anxiety, and sleep disturbances in sexual and gender minority adults.
- Conditions
- Minority Stress, Psychological Stress, Anxiety
- Being tested
- Ashwagandha Root Extract, Placebo Capsule
- Keywords
- Ashwagandha, LGBTQ health, Withania somnifera
- Medical subject headings
- Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ashwagandha Root ExtractDietary supplement
Also called ARE
Ashwagandha (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 CapsuleOther
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Ashwagandha Root Extract | Experimental | Participants will receive Ashwagandha (Withania somnifera) root extract capsules at a dose of 300 mg taken orally twice daily for 8 weeks. Receives: Dietary Supplement: Ashwagandha Root Extract |
| Placebo (Inactive capsule) | Placebo comparator | Participants will receive identical placebo capsules containing starch, taken orally twice daily for 8 weeks. Receives: Other: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (9)
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
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.
Measured: Baseline, Week 4, and Week 8
Change in Profile of Mood States (POMS) Score
The Profile of Mood States (POMS) is a validated questionnaire assessing mood disturbance across six domains: tension, depression, anger, vigor, fatigue, and confusion. The Total Mood Disturbance (TMD) score typically ranges from -32 to 200 (depending on scoring method), with higher scores indicating greater mood disturbance (worse outcome).
This outcome measures the mean change from baseline in POMS Total Mood Disturbance and subscale scores, where a reduction in TMD score indicates improvement in mood state.
Measured: Baseline, Week 4, and Week 8
Change in Salivary Cortisol Awakening Response
Change in cortisol awakening response measured using salivary cortisol samples.
Measured: Baseline and Week 8
Change in Bedtime Salivary Cortisol Level
Change in bedtime salivary cortisol as a biomarker of stress regulation.
Measured: Baseline and Week 8
Incidence of Treatment-Emergent Adverse Events
Number and proportion of participants experiencing treatment-emergent adverse events.
Measured: Baseline, Week 4, and Week 8
Incidence of Treatment-Emergent Serious Adverse Events
Number and proportion of participants experiencing treatment-emergent serious adverse events.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start29 Apr 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minority StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Ixoreal Biomed Private Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441070
- Sponsor's protocol ID
- Ixo/2025/1201/ARE/LGBTQ/SF/01
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07441070
- Acronym / sponsor ID
- Ixo/2025/1201/ARE/LGBTQ/SF/01
- Conditions
- Minority Stress, Psychological Stress, Anxiety
- Keywords
- Ashwagandha, LGBTQ health, Withania somnifera
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Ixoreal Biomed Private Limited
- Study start
- 29 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Minority stress is a well-established contributor to mental health disparities among sexual and gender minority populations. Chronic exposure to stigma, discrimination, and social rejection activates stress-related neuroendocrine pathways, including dysregulation of the hypothalamic-pituitary-adrenal axis, leading to sustained elevations in cortisol and adverse psychological outcomes such as anxiety, mood disturbances, and poor sleep quality.
Ashwagandha (Withania somnifera) is a traditional Ayurvedic medicinal herb recognized for its adaptogenic properties. It has been shown to modulate stress responses, reduce cortisol levels, and improve psychological well-being and sleep in stressed adults. However, its effects have not been specifically evaluated in individuals experiencing minority stress.
This is a single-center, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of Ashwagandha root extract in adults experiencing minority stress. Eighty eligible participants will be randomized in a 1:1 ratio to receive either Ashwagandha root extract (300 mg capsules taken orally twice daily) or an identical placebo for a duration of 8 weeks.
Study assessments will be conducted at baseline, Week 4, and Week 8. Primary efficacy will be evaluated using the Perceived Stress Scale (PSS-10). Secondary outcomes include measures of anxiety, mood, sleep quality, quality of life, minority stress experiences, and salivary cortisol levels. Safety will be assessed through systematic recording of treatment-emergent adverse events and serious adverse events.
The results of this study will provide clinical evidence regarding the role of Ashwagandha supplementation as a supportive intervention for stress, anxiety, and sleep disturbances in sexual and gender minority adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ashwagandha Root Extract | Experimental | Dietary Supplement: Ashwagandha Root ExtractParticipants will receive Ashwagandha (Withania somnifera) root extract capsules at a dose of 300 mg taken orally twice daily for 8 weeks. |
| Placebo (Inactive capsule) | Placebo comparator | Other: Placebo CapsuleParticipants will receive identical placebo capsules containing starch, taken orally twice daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ashwagandha Root ExtractAlso: AREAshwagandha (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. | Dietary supplement | Ashwagandha Root Extract |
| Placebo CapsuleThe 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. | Other | Placebo (Inactive capsule) |
Primary outcome
Change in Perceived Stress Scale (PSS-10) Score
Time frame: Baseline, Week 4, and Week 8
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.
9 secondary outcomes
Change in Depression Anxiety Stress Scale (DASS-21) Scores
Time frame: Baseline, Week 4, and Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, Week 4, and Week 8
Change in Minority Stress Measured by DHEQ-S-12
Time frame: Baseline, Week 4, and Week 8
Change in Quality of Life Measured by WHOQOL-BREF
Time frame: Baseline, Week 4, and Week 8
Change in Profile of Mood States (POMS) Score
Time frame: Baseline, Week 4, and Week 8
Change in Salivary Cortisol Awakening Response
Time frame: Baseline and Week 8
Change in Bedtime Salivary Cortisol Level
Time frame: Baseline and Week 8
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline, Week 4, and Week 8
Incidence of Treatment-Emergent Serious Adverse Events
Time frame: Baseline, Week 4, and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ashwagandha Root Extract in people with Minority Stress and Psychological Stress, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. John Ademola (415-845-4638, jademola@sfinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS-10) Score (time frame: Baseline, Week 4, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.