Recruiting

Ashwagandha Extract

Sponsor:

Nutraceuticals Research Institute

Code:

NCT06793891

Conditions

Stress

Eligibility Criteria

Sex: Female

Age: 30 - 59

Healthy Volunteers: Accepted

Interventions

ashwagandha root

ashwagandha root and leaf

placebo

Study Details

Brief 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.

Conditions

Stress

Study ID

NCT06793891

Start date

Oct 21, 2024

Status verified date

Jan, 2025

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 59

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Plant Extract 1

Participants in this arm will take an ashwagandha root supplement each day for 60 days.

experimental: Plant Extract 2

Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days.

placebo comparator: Placebo

Participants in this arm will take an inert placebo each day for 60 days.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jessie Hawkins, PhD

256-203-9010j.hawkins@nutraceuticalsresearch.com

Locations

Nutraceuticals Research Institute

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

JESSIE HAWKINS, PhD

256-203-9010j.hawkins@nutraceuticalsresearch.com

More Information

Sponsor

Nutraceuticals Research Institute

Last update posted

Jan 27, 2025

Last verified

Jan, 2025

Keywords

  • energy
  • fatigue
  • cognition
  • nutraceuticals
  • Ashwagandha

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nutraceuticals Research Institute on 2025-01-27.