Effects of Ashwagandha Extract on Stress Levels
Nutraceuticals Research Institute · NCT06793891
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 30–59 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 60
- US sites recruiting
- 1
- Study start
- October 21, 2024
- Record last updated
- January 27, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ashwagandha root; ashwagandha root and leaf; placebo
Conditions: Stress
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Nutraceuticals Research Institute
Huntsville, AL 35801
Site contact: JESSIE HAWKINS, PhD · 256-203-9010 · j.hawkins@nutraceuticalsresearch.com
Study contacts (from the official record)
- Jessie Hawkins, PhD · 256-203-9010 · j.hawkins@nutraceuticalsresearch.com
Similar studies in Alabama
All healthy volunteers studies in Alabama →- RecruitingHealthy volunteersPhase 1/Phase 2
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Novartis Pharmaceuticals
- Location
- Birmingham, AL + 7 other US sites
- Eligibility basics
- Ages 12–55
- RecruitingHealthy volunteersPhase 1/Phase 2
Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
Sanofi
- Location
- Gadsden, AL + 49 other US sites
- Eligibility basics
- Ages 60+
- RecruitingHealthy volunteersPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Regeneron Pharmaceuticals
- Location
- Birmingham, AL + 5 other US sites
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersPhase 1
A Study of Ulonivirine (MK-8507) and Methadone in Healthy Volunteers (MK-8507-019)
Merck Sharp & Dohme LLC
- Location
- Anniston, AL
- Eligibility basics
- Ages 18–65