Radicle Relaxation™ 24_VNS: A Study Assessing the Impact of Health and Wellness Products on Stress and Related Health Outcomes
Launched by RADICLE SCIENCE · May 22, 2025
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
The Radicle Relaxation™ 24_VNS study is looking at how certain health and wellness products can help reduce stress and improve overall health. This study is designed for adults aged 21 and older who live in the United States and are experiencing stress. Participants will be randomly assigned to receive either an active wellness product or a placebo (which looks like the actual product but has no active ingredients) without knowing which one they have. The goal is to see if these products can help people improve their stress levels by at least 30%.
To join the study, you must be at least 21 years old and be willing to try the product without knowing what it is. However, if you're pregnant, trying to become pregnant, or breastfeeding, or if you have certain health issues or are taking specific medications, you won't be able to participate for safety reasons. If you decide to take part, you can expect to receive a product at home and participate in follow-up activities to track any changes in your stress levels and health outcomes. This study is not yet recruiting, so there’s still time to learn more and see if it might be a good fit for you or someone you know.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
About Radicle Science
Radicle Science is an innovative clinical trial sponsor dedicated to advancing healthcare through the integration of cutting-edge technology and robust scientific research. Specializing in decentralized clinical trials, Radicle Science leverages real-world data and digital health solutions to enhance patient engagement and streamline study processes. Committed to transparency and collaboration, the company aims to accelerate the development of new therapies while ensuring rigorous adherence to regulatory standards. With a focus on improving health outcomes, Radicle Science is at the forefront of transforming the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Del Mar, California, United States
Patients applied
Trial Officials
Susan Hewlings
Principal Investigator
Radicle Science Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported