NCT06793891 Effects of Ashwagandha Extract on Stress Levels
| NCT ID | NCT06793891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nutraceuticals Research Institute |
| Condition | Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-10-21 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study * Self reported high stress * Baseline score of above-average stress levels on the NRI-SS * Biological sex of woman; gender identification of female * Aged 30 to 59, inclusive * Good general health as evidenced by medical history and screening * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study * Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: * Pregnancy, trying to conceive, or breastfeeding * Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year * Consumes \> 8 alcoholic beverages in an average week * Is a primary caretaker for a child younger than 18 months of age * Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months * Consumes any stress aid, medication, diet, or supplement intended to improve stress in any way * Current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants * Any liver or kidney disorder * Known allergic reactions to any components of the intervention * Positive COVID-19 test within 30 days of the study period * Recent dramatic weight changes (10% change in body weight in the last 6 months) * Introducing a new investigational drug or other intervention within 60 days before the start of the study * Introducing a new lifestyle stress-reduction aid (i.e. physical activity, yoga, etc) within 60 days before the start of the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06793891 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 59 Years, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06793891 currently recruiting?
Yes, NCT06793891 is actively recruiting participants. Contact the research team at j.hawkins@nutraceuticalsresearch.com for enrollment information.
Where is the NCT06793891 trial being conducted?
This trial is being conducted at Huntsville, United States.
Who is sponsoring the NCT06793891 clinical trial?
NCT06793891 is sponsored by Nutraceuticals Research Institute. The trial plans to enroll 60 participants.