Radicle Revive™ CSP: A Trial Evaluating Plant-Based Health and Wellness Products on Perimenopausal Women's Self-Reported Health Issues and Outcomes

January 22, 2026 updated by: Radicle Science

Radicle Revive™ CSP: A Randomized, Double-Blind, Placebo-Controlled, Trial Evaluating Plant-Based Health and Wellness Products on Perimenopausal Women's Self-Reported Health Issues and Outcomes

A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on perimenopausal women's self-reported health issues and outcomes

Study Overview

Status

Completed

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 (1) are female, (2) are perimenopausal, (3) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (4) express acceptance in taking study products and not knowing the formulation identities 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 women who 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 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.

Study Type

Interventional

Enrollment (Actual)

900

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 Locations

  • United States
    • California
      • Del Mar, California, United States, 92014
        • Radicle Science, Inc

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults, aged 37 - 55 years at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
  • Assigned sex at birth is female
  • Resides in the United States
  • Identifies menstrual status as perimenopausal
  • 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:

  • Reports 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.
  • 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, 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 to participants
  • Reports an allergy to and/or disinterest in any of the possible study product ingredients
  • Lack of reliable daily access to the internet

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 Form - Control
Dietary supplement: Revive Product Form - Placebo Control
Participants will use their Revive Product Form - Placebo Control as directed for a period of 12 weeks.
Experimental: Active Product
Revive Product Form - Active
Dietary supplement: Revive Product Form - Active
Participants will use their Revive Product Form - Active as directed for a period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in menopausal health issues
Time Frame: 13 weeks
Difference between rates of change over time in menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in feelings of anger
Time Frame: 13 weeks
Difference between rates of change over time in anger score as assessed by PROMIS Anger 5A (scale 5-25; with higher scores corresponding to more severe anger)
13 weeks
Change in feelings of anxiety
Time Frame: 13 weeks
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
Change in sleep
Time Frame: 13 weeks
Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
13 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal clinically important difference (MCID) in menopausal health issues
Time Frame: 13 weeks
Likelihood of experiencing minimal clinically important difference in menopausal health issues score assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)
13 weeks
Minimal clinically important difference (MCID) in feelings of anger
Time Frame: 13 weeks
Likelihood of experiencing minimal clinically important difference in anger score as assessed by PROMIS Anger 5A (scale 5-25; with higher scores corresponding to more severe anger)
13 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Time Frame: 13 weeks
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
Minimal clinically important difference (MCID) in sleep
Time Frame: 13 weeks
Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
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)

August 26, 2025

Primary Completion (Actual)

January 8, 2026

Study Completion (Actual)

January 8, 2026

Study Registration Dates

First Submitted

August 22, 2025

First Submitted That Met QC Criteria

August 22, 2025

First Posted (Actual)

August 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • RADX_C_2507_SP

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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