RECRUITING

Effects of Ashwagandha Extract on Stress Levels

Conditions

Stress energy fatigue cognition nutraceuticals Ashwagandha

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-21

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06793891

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.

Ages Eligible for Study:30 Years to 59 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jessie Hawkins, PhD

CONTACT

256-203-9010

j.hawkins@nutraceuticalsresearch.com

Study Locations (Sites)

Nutraceuticals Research Institute

Huntsville, Alabama, 35801

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-10-21

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2024-10-21

Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

energy
fatigue
cognition
nutraceuticals
Ashwagandha

Additional Relevant MeSH Terms

Stress