Actively Recruiting
Effects of Ashwagandha Extract on Stress Levels
Led by Nutraceuticals Research Institute · Updated on 2025-01-27
60
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Effects of Ashwagandha Extract on Stress Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of signed and dated informed consent form
- Willingness and ability to comply with all study procedures and availability for the study duration
- Self-reported high stress
- Baseline score above average on the Nutraceuticals Research Institute's Stress Scale
- Biological sex female; gender identification female
- Aged 30 to 59 years inclusive
- Good general health based on medical history and screening
- For females of reproductive potential, use of highly effective contraception for at least 1 month before screening and during study participation, plus 1 month after study end
- Agreement to follow lifestyle considerations throughout the study
You will not qualify if you...
- Pregnancy, trying to conceive, or breastfeeding
- Current smoking or vaping or within the past year
- Consuming more than 8 alcoholic beverages per week on average
- Primary caretaker of a child younger than 18 months
- Regular ashwagandha supplement use (1x week or more) in the past 24 months
- Use of any stress aid, medication, diet, or supplement intended to improve stress
- Use of thyroid, hypertensive, CNS depressant, diabetic, benzodiazepine, or immunosuppressant medications within 60 days
- Any liver or kidney disorder
- Known allergies to any intervention components
- Positive COVID-19 test within 30 days before the study
- Significant weight change (10%) in the last 6 months
- Starting a new investigational drug or intervention within 60 days before the study
- Starting a new lifestyle stress-reduction aid within 60 days before the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nutraceuticals Research Institute
Huntsville, Alabama, United States, 35801
Actively Recruiting
Research Team
J
Jessie Hawkins, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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