Effects of Ashwagandha Extract on Stress Levels

Launched by NUTRACEUTICALS RESEARCH INSTITUTE · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how two special forms of ashwagandha, a natural herb known for its potential stress-relieving properties, can affect stress levels in women aged 30 to 59. Researchers want to see if these extracts can help reduce stress, improve thinking abilities, boost energy, and enhance sleep compared to a placebo (a harmless substance that looks like the real treatment but has no active ingredients). The study is currently recruiting participants who are women, report high stress, and are generally in good health.

To join the trial, participants need to agree to follow the study rules and be available for its duration. They must also use reliable birth control if they are capable of becoming pregnant and not be using any other stress-relief supplements or medications. During the study, participants will take the ashwagandha extract or placebo and monitor their stress and overall well-being. This trial aims to provide helpful insights into how ashwagandha might benefit those experiencing high stress levels.

Gender

FEMALE

Eligibility 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