Evaluating the effects of Ashwagandha on stress levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy of two proprietary ashwagandha extracts in reducing stress levels compared to a placebo. Participants will take either the ashwagandha root extract, a combination of root and leaf extracts, or a placebo daily for 60 days. The study will measure outcomes related to stress, sleep, energy, and cognition to determine the effectiveness of the interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• Nutraceuticals Research Institute
  Huntsville, Alabama, United States Recruiting

Study contacts

• Study coordinator: Jessie Hawkins, PhD
• Email: j.hawkins@nutraceuticalsresearch.com
• Phone: 256-203-9010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.