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

The Radicle Calm 24 clinical trial is studying how health and wellness products can help reduce feelings of anxiety and improve overall health. This study is designed for adults aged 21 and older living in the United States who want to manage their anxiety better. Participants will be randomly assigned to receive either a product that may help with anxiety or a placebo, which looks the same but does not contain the active ingredients. Importantly, participants will not know which product they are taking until the study is completed.

To join the trial, individuals should be willing to commit to using the study product and should be seeking to reduce their anxiety. However, there are some exclusions; for example, people who are pregnant, have certain serious health conditions, or are currently enrolled in another clinical trial cannot participate. Throughout the study, participants can expect to engage in regular assessments to measure their anxiety levels and general health. This study is currently active but not recruiting new participants at this time.

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