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

April 17, 2026 updated by: Radicle Science

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

990

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Control
Revive Product Placebo Control
Dietary supplement: Revive Product Placebo Control
Participants will use their Control as directed for a period of 12 weeks.
Experimental: Active Revive Product 1
Revive Active Product 1
Dietary supplement: Revive Active Product 1
Participants will use their Active product as directed for a period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function
Time Frame: 13 weeks
Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive abilities
Time Frame: 13 weeks
Change in cognitive abilities: Difference between rates of change over time in Cognitive Abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
13 weeks
Change in feelings of anxiety
Time Frame: 13 weeks
Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
13 weeks
Hot Flash Interference over 12 weeks
Time Frame: From Baseline to week 12 of product consumption.
Hot Flash interference assessed by a single self report item. Indicating hot flash interference in the previous 24 hours. Scale 1-7 with higher scores indication greater interference.
From Baseline to week 12 of product consumption.
Hot Flash Frequency
Time Frame: From baseline to day 14 of product consumption.
Hot Flash frequency assessed by a single self-report item. Indicating hot flash frequency in the previous 24 hours. Options ranged from 0 to 6. With higher scores indicating greater frequency of hot flashes.
From baseline to day 14 of product consumption.
Hot Flash Interference over 14 days
Time Frame: From Baseline to day 14 of product consumption.
Hot Flash interference assessed by a single self report item. Indicating hot flash interference in the previous 24 hours. Scale 1-7 with higher scores indication greater interference.
From Baseline to day 14 of product consumption.
Hot Flash Frequency
Time Frame: From baseline to week 12 of product consumption.
Hot Flash frequency assessed by a single self-report item. Indicating hot flash frequency in the previous 24 hours. Options ranged from 0 to 6. With higher scores indicating greater frequency of hot flashes.
From baseline to week 12 of product consumption.
Hot Flash Intensity
Time Frame: From baseline to week 12 of product consumption.
Hot Flash intensity assessed by a single self-report item. Indicating hot flash intensity in the previous 24 hours. Options ranged from 1 to 7. With higher scores indicating greater intensity of hot flashes.
From baseline to week 12 of product consumption.
Hot Flash Intensity
Time Frame: From baseline to day 14 of product consumption.
Hot Flash intensity assessed by a single self-report item. Indicating hot flash intensity in the previous 24 hours. Options ranged from 1 to 7. With higher scores indicating greater intensity of hot flashes.
From baseline to day 14 of product consumption.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal clinically important difference (MCID) in cognitive function
Time Frame: 13 weeks
Minimal clinically important difference (MCID) in cognitive function: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)
13 weeks
Minimal clinically important difference (MCID) in cognitive abilities
Time Frame: 13 weeks
Minimal clinically important difference (MCID) in cognitive abilities: Likelihood of experiencing minimal clinically important difference in cognitive abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
13 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Time Frame: 13 weeks
Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radicle Science

Investigators

  • Principal Investigator: Susan Hewlings, Radicle Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2026

Primary Completion (Estimated)

April 7, 2027

Study Completion (Estimated)

April 7, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • RADX_P_2605_RGW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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