Effects of Ashwagandha Extract on Stress Levels

January 21, 2025 updated by: Jessie Hawkins, Nutraceuticals Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plant Extract 1
Participants in this arm will take an ashwagandha root supplement each day for 60 days.
Dietary supplement: ashwagandha root
This substance is extracted from the root of the plant.
Experimental: Plant Extract 2
Participants in this arm will take an ashwagandha root and leaf supplement each day for 60 days.
Dietary supplement: ashwagandha root and leaf
This substance is extracted from both the root and leaves of the plant.
Placebo Comparator: Placebo
Participants in this arm will take an inert placebo each day for 60 days.
Other: placebo
The inert placebo does not contain any of the plant matter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 days
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.
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 days
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
60 days
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
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nutraceuticals Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-09-900

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Consent to share IPD will not been obtained from participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress

Clinical Trials on ashwagandha root

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe