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NCT Number: NCT06793891

Effects of Ashwagandha Extract on Stress Levels

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.

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Key information

Age range

30 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nutraceuticals Research Institute

Huntsville, Alabama, 35801, United States

Location status: Recruiting

Location contact

JESSIE HAWKINS, PhD

CONTACT

[email protected]

256-203-9010

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ashwagandha root

Dietary Supplement

This substance is extracted from the root of the plant.

ashwagandha root and leaf

Dietary Supplement

This substance is extracted from both the root and leaves of the plant.

Placebo

Other

The inert placebo does not contain any of the plant matter.

Primary outcomes

  1. Post-test Cortisol Awakening Response, after controlling for baseline scores

    Time frame: 60 days

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

  2. NRI-SS (Nutraceuticals Research Institute's Stress Scale)

    Time frame: 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.

Secondary outcomes

  1. NRI-ES (Nutraceuticals Research Institute's Energy Scale)

    Time frame: 60 days

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

  2. NRI-Sleep (Nutraceuticals Research Institute's Sleep Scale)

    Time frame: 60 days

    This is a validated scale measuring 7 subdomains of sleep. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of sleep

  3. NRI-Cognition Scale

    Time frame: 60 days

    This is a validated scale measuring 6 subdomains of cognition. It is measured on a likert scale. Scores on each subdomain can range from 5-42 with higher scores indicating greater quality of cognitive health

Study contacts

Contact information is provided by the study sponsor or research team.

Jessie Hawkins, PhD

CONTACT

[email protected]

256-203-9010

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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