RecruitingNot ApplicableNCT07548307

Radicle Revive™: A Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes

Radicle Revive™: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes

Sponsor

Radicle Science

Enrollment

990 participants

Start Date

Apr 9, 2026

Study Type

INTERVENTIONAL

Conditions

Cognitive Function

Summary

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.

Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 105 Years

Inclusion Criteria7

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 Criteria15

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