Radicle Revive™: A Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes
Purpose
Radicle Revive™: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on menopausal-related health issues associated health outcomes.
Condition
- Cognitive Function
Eligibility
- Eligible Ages
- Between 40 Years and 105 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- Resides in the United States
- Has the opportunity for at least 30% improvement in their primary health outcome
- Peri or Post Menopausal women who have been experiencing hot flashes for the past 3
months or longer
- 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
- Currently taking a HRT medication
- Pre-Menopausal women
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be stratified based on menstrual status, hot flash interference, 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 |
Revive Product Placebo Control |
|
|
Experimental Active Revive Product 1 |
Revive Active Product 1 |
|
Recruiting Locations
Del Mar, California 92014
More Details
- Status
- Recruiting
- 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) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, (2) express acceptance in taking a product and not knowing its formulation until the end of the study, and Peri or Post menopausal women (3) regularly experiencing hot flashes and (4) Not taking a HRT medication. 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 13 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.