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NCT07745010
Radicle Energy™ DNB: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes
Conditions: Fatigue
Sex: All
Ages: 40 Years – 105 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 1320
Sponsor: Radicle Science
Location: Radicle Science Inc. Del Mar California
Summary
Radicle Energy™ DNB: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes
Eligibility Criteria
\- Inclusion
Participants must meet all the following criteria:
* Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
* Assigned sex at birth will determine sex-specific recruitment and PROs (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
Individuals who report any of the following during screening may be excluded from participation:
* 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 at a 7th grade level
* 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 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.
* 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 safety risk
* Lack of reliable daily access to the internet
Source: ClinicalTrials.gov (NCT07745010). StuddyBuddy aggregates publicly available trial information.