Phase
Condition
Stress
Treatment
ashwagandha root
placebo
ashwagandha root and leaf
Clinical Study ID
Ages 30-59 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness and demonstrated ability to comply with all study procedures, aswell 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 atleast 1 month prior to screening and agreement to use such a method during studyparticipation and for an additional month after the end of the study
Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion
Exclusion Criteria:
Pregnancy, trying to conceive, or breastfeeding
Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has inthe 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 (definedas 1x week or more often) within the past 24 months
Consumes any stress aid, medication, diet, or supplement intended to improve stressin any way
Current or recent (within 60 days) history of taking thyroid medications,hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, orimmunosuppressants
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 beforethe 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
Study Design
Study Description
Connect with a study center
Nutraceuticals Research Institute
Huntsville, Alabama 35801
United StatesActive - Recruiting
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