Radicle Revive: Supplement for menopause-related hot flashes and thinking and memory changes
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
This trial tests whether the Radicle Revive supplement can help peri- and postmenopausal women who have regular hot flashes and changes in thinking or memory.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 990 (estimated) |
| Ages | 40 Years to 105 Years |
| Sex | Female |
| Sponsor | Radicle Science Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Del Mar, California) |
| Trial ID | NCT07548307 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled, 13-week, remote study run in the United States comparing an active Radicle Revive product to a placebo. Adults aged 40 and older who are peri- or postmenopausal and regularly experience hot flashes may enroll if they are not currently using hormone replacement therapy and are willing to be blinded to product identity. All data are self-reported electronically at enrollment and during the active product period, with no in-person visits required. Participants with significant cardiac, liver, or kidney disease, heavy alcohol use, pregnancy, breastfeeding, or contraindicated medications may be excluded for safety reasons.
Who should consider this trial
Good fit: Peri- or postmenopausal women aged 40 or older who live in the U.S., have had regular hot flashes for at least three months, are not on HRT, and are willing to take a blinded study product are ideal candidates.
Not a fit: People with known heart, liver, or kidney disease, heavy drinkers, those who are pregnant, trying to become pregnant, breastfeeding, or taking contraindicated medications, as well as individuals without hot flashes, are unlikely to benefit or may be excluded for safety.
Why it matters
Potential benefit: If successful, the product could reduce hot flashes and improve cognitive symptoms during menopause, offering a non-hormonal option for symptom relief.
How similar studies have performed: Over-the-counter wellness supplements for menopausal symptoms have shown mixed and limited evidence in prior work, so rigorous randomized, double-blind placebo-controlled data remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Del Mar, California
- Radicle Science Inc. — Del Mar, California, United States (Recruiting)
Study contacts
- Principal investigator: Susan Hewlings — Radicle Science
- Study coordinator: Study Manager
- Email: studymgmt@radiclescience.com
- Phone: 858-779-0086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.