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Ashwagandha Extract for Stress Levels

This study is looking at how two different ashwagandha extracts affect stress levels in women aged 30 to 59. One extract comes from the ashwagandha root, and the other comes from both the root and leaves. You would be given one of these extracts or a placebo (an inactive substance) to take daily. Researchers want to see if these extracts can lower stress, and they will measure this by looking at your cortisol awakening response (a hormone related to stress) and your scores on a stress scale after 60 days. They will also look at how the extracts affect your cognition (thinking), energy, and sleep. To join, you need to report high stress and have above-average stress levels on a specific scale. The current status of this study is unclear, but it plans to enroll 60 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 women aged 30-59.
What's involved
Participants will take one of two ashwagandha extracts or a placebo every day for 60 days. Stress, sleep, energy, and cognition will be measured.
Compensation
Not stated in the trial record.
Follow-up
Measurements for primary outcomes will be taken at 60 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06793891

Effects of Ashwagandha Extract on Stress Levels

Recruiting
NAAges 30–59Interventional
Nutraceuticals Research Institute
~60 participants
Updated 2025-01-27 on ClinicalTrials.gov
What's tested:ashwagandha rootashwagandha root and leafplacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post-test Cortisol Awakening Response, after controlling for baseline scores
Measured over 60 days
+1 more outcome measured

Conditions

Stress

Explore related trials

Stress

Where it's being run

1 sites across 1 states
Alabama1

Who to contact

Jessie Hawkins, PhD
[email protected]
256-203-9010
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Post-test Cortisol Awakening Response, after controlling for baseline scores60 days

    salivary cortisol levels will be taken immediately after waking and 30 minutes later to produce a composite score

  • NRI-SS (Nutraceuticals Research Institute's Stress Scale)60 days

    This is a validated scale measuring 6 subdomains of stress. It is measured on a likert scale. Scores on each subdomain can range from 5 to 42, with higher scores indicating greater stress levels.