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Recruiting NCT06793891

Effects of Ashwagandha Extract on Stress Levels

No phase Interventional Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ashwagandha root, ashwagandha root and leaf, placebo.
Who it may be relevant to
Registry conditions: Stress. Basic parameters: 30 years — 59 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effectiveness of a Proprietary Ashwagandha Extract on Stress Reduction: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial

Overview

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.

Detailed description

Participants will take one of two extracts or a placebo every day for 60 days; outcomes of stress, sleep, energy, and cognition will provide information on effectiveness.

Interventions

  • Dietary supplement ashwagandha root
    This substance is extracted from the root of the plant.
  • Dietary supplement ashwagandha root and leaf
    This substance is extracted from both the root and leaves of the plant.
  • Other placebo
    The inert placebo does not contain any of the plant matter.

Primary outcome measures

  • Post-test Cortisol Awakening Response, after controlling for baseline scores [Time frame: 60 days]
  • NRI-SS (Nutraceuticals Research Institute's Stress Scale) [Time frame: 60 days]
Secondary outcome measures (3)
  • NRI-ES (Nutraceuticals Research Institute's Energy Scale) [Time frame: 60 days]
  • NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale) [Time frame: 60 days]
  • NRI-Cognition Scale [Time frame: 60 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Nutraceuticals Research Institute — Huntsville

Identifiers

NCT: NCT06793891 · 24-09-900

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗