Effects of Ashwagandha Extract on Stress Levels

Last updated: January 21, 2025
Sponsor: Nutraceuticals Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Treatment

ashwagandha root

placebo

ashwagandha root and leaf

Clinical Study ID

NCT06793891
24-09-900
  • Ages 30-59
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

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

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: ashwagandha root
Phase:
Study Start date:
October 21, 2024
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Nutraceuticals Research Institute

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

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