Radicle Health 24: A Study of Health and Wellness Products on Overall Health
Purpose
A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on overall health
Condition
- Overall Health
Eligibility
- Eligible Ages
- Between 21 Years and 105 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Adults, at least 21 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 surveys (male vs female) employed, when needed - Resides in the United States - Endorses better overall health as a primary desire - 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 - Lack of reliable daily access to the internet
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be stratified based on their gender assigned at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
- Masking Description
- The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo control 7.1.0 |
Health product 7.1.0 - control |
|
|
Experimental Active product 7.1.1 |
Health product 7.1.1 - active product 1 |
|
|
Experimental Active product 7.1.2 |
Health product 7.1.2 - active product 2 |
|
|
Placebo Comparator Placebo control 7.2.0 |
Health product 7.2.0 - control |
|
|
Experimental Active product 7.2.1 |
Health product 7.2.1 - active product 1 |
|
Recruiting Locations
More Details
- NCT ID
- NCT06989710
- Status
- Completed
- Sponsor
- Radicle Science
Detailed Description
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 better overall health, (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 safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.