Actively Recruiting
Effectiveness of Two Proprietary Ashwagandha Extracts Compared to Placebo for Stress Reduction in Women: A Randomized, Double-Blind Trial
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
This research aims to evaluate the effectiveness of two proprietary ashwagandha extracts on reducing stress levels in women aged 30 to 59. The study also looks at secondary effects on cognition, energy, and sleep. Participants must report high stress and have above-average stress scores at the start of the study. The trial is designed as a three-arm, randomized, double-blinded, placebo-controlled clinical trial to compare the effects of the ashwagandha extracts against a placebo. Participants will take one of two ashwagandha extracts—one from the root only and another from both root and leaves—or a placebo daily for 60 days. The placebo contains no plant matter. All participants will follow lifestyle considerations during the study and, if of reproductive potential, must use highly effective contraception before and during the trial. The study focuses on the impact of these supplements on stress and related outcomes over the two-month period. During the study, researchers will measure stress levels using the Cortisol Awakening Response and the Nutraceuticals Research Institute's Stress Scale at 60 days, adjusting for baseline scores. Participants will be assessed for changes in cognition, energy, and sleep. The study includes monitoring for safety and adherence, with participants providing informed consent and agreeing to comply with all procedures throughout the study duration.
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
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Trial Site Locations
Total: 1 location
1
Nutraceuticals Research Institute
Huntsville, Alabama, United States, 35801
Actively Recruiting
Research Team
J
Jessie Hawkins, PhD
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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