Radicle Relaxation™ 24_VNS: A Study Assessing the Impact of Health and Wellness Products on Stress and Related Health Outcomes

Completed · Not applicable · Has a placebo group

Conditions studied: Stress

In brief

A randomized, double-blind, placebo controlled direct-to-consumer study assessing the impact of health and wellness products on stress and related health outcomes

Key facts

Study ID

NCT06999629

Run by

Radicle Science

People needed

900

Starts

2025-06-03

Expected to finish

2025-10-08

Last updated by the study team

2025-11-03

Who can join

Age: 21 and older, up to 105. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities o Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• Resides in the United States
• Has the opportunity for at least 30% improvement in their primary health outcome ● Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

You may not qualify if…

• Report being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number ● Reports current enrollment in another clinical trial
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
• Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
• o NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. o Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a known safety risk
• Lack of reliable daily access to the internet

Where it is running

• Radicle Science, Inc — Del Mar, California, United States

Full record on ClinicalTrials.gov

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