Status:
COMPLETED
Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes
Lead Sponsor:
Radicle Science
Conditions:
Fatigue
Energy
Eligibility:
All Genders
21-105 years
Phase:
NA
Brief Summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on fatigue and other health outcomes
Detailed Description
This is a parallel group, randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) en...
Eligibility Criteria
Inclusion
- Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, and 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 more energy as a primary desire
- Has the opportunity for at least 20% improvement in their primary health outcome score
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Exclusion
- Reports being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Reports a diagnosis of liver or kidney disease
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English
- Reports current enrollment in another clinical trial
- Lack of reliable daily access to the internet
- Reports current use of chemotherapy or immunotherapy
- Reports taking medications that have a well-established moderate or severe interaction, or pose a substantial safety risk with the active ingredients studied: Anticoagulants, antihypertensives, anti-anxiolytics, antidepressants, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products
- Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2024
Estimated Enrollment :
1189 Patients enrolled
Trial Details
Trial ID
NCT06074627
Start Date
September 26 2023
End Date
May 3 2024
Last Update
July 10 2024
Active Locations (1)
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1
Radicle Science, Inc
Del Mar, California, United States, 92014