Radicle Calm 24: a Study of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes

Launched by RADICLE SCIENCE · May 23, 2024

Keywords

ClinConnect Summary

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) endorse a desire for less feelings of anxiety (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant s...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults, at least 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• • Resides in the United States
• • Endorses less anxiety as a primary desire
• • Has the opportunity for at least 20% 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:
• • Reports 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. NYHA (New York Heart Association) Class Ill 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. Anticoagulants, antihypertensive, 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, MAOls (monoamine oxidase inhibitors), or thyroid products
• • Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s)
• • Lack of reliable daily access to the internet

Trial Officials