Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-21
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Plant Extract 1
Participants in this arm will take an ashwagandha root supplement each day for 60 days.
ashwagandha root
This substance is extracted from the root of the plant.
Plant Extract 2
Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days.
ashwagandha root and leaf
This substance is extracted from both the root and leaves of the plant.
Placebo
Participants in this arm will take an inert placebo each day for 60 days.
placebo
The inert placebo does not contain any of the plant matter.
Interventions
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ashwagandha root
This substance is extracted from the root of the plant.
ashwagandha root and leaf
This substance is extracted from both the root and leaves of the plant.
placebo
The inert placebo does not contain any of the plant matter.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
59 Years
FEMALE
Yes
Sponsors
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Nutraceuticals Research Institute
OTHER
Responsible Party
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Jessie Hawkins
PhD
Locations
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Nutraceuticals Research Institute
Huntsville, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-09-900
Identifier Type: -
Identifier Source: org_study_id
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