Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes

Radicle Revive™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Trial Assessing the Impact of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Menopausal Health Issues

A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues

Study Overview

• Status: Completed
• Conditions: Depression; Fatigue; Anxiety; Menopause; Sleep Disturbance; Cognitive Function; Libido
• Intervention / Treatment: Dietary supplement: Radicle Revive Placebo Control Form 4.1; Dietary supplement: Radicle Revive Active Study Product 4.1 Usage

Detailed Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants (1) are females, (2) have menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, 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 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 7 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): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
• Resides in the United States
• Endorses less pain as a primary desire
• Selects pain and/or looking to improve their pain as a reason for their interest in taking a health and wellness product
• 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
• The calculated validated health survey (PRO) score during enrollment represents less than mild severity
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports current enrollment in a clinical trial
• Lack of reliable daily access to the internet
• Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
• Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAO

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control 4.1.0; Revive product form 4.1 - control	Dietary supplement: Radicle Revive Placebo Control Form 4.1; Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Experimental: Active product 4.1.1; Revive product form 4.1 - active product 1	Dietary supplement: Radicle Revive Active Study Product 4.1 Usage; Participants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in feelings of anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	6 weeks
Change in feelings of anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)	6 weeks
Change in feelings of depression	Mean difference in depression score as assessed by PROMIS Depression 4A (scale 4-20; with higher scores corresponding to more severe depression)	6 weeks
Change in cognitive function	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with lower scores corresponding to better cognitive function)	6 weeks
Change in cognitive function	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; with lower scores corresponding to better cognitive function)	6 weeks
Change in sleep disturbance	Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; with higher scores corresponding to more severe sleep disturbance)	6 weeks
Change in sleep disturbance	Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; with higher scores corresponding to more severe sleep disturbance)	6 weeks
Change in fatigue	Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to more severe fatigue)	6 weeks
Change in feelings of depression	Mean difference in depression score as assessed by PROMIS Depression 8A (scale 8-40; with higher scores corresponding to more severe depression)	6 weeks
Change in fatigue	Mean difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; with higher scores corresponding to more severe fatigue)	6 weeks
Change in Pain Interference	Mean difference in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)	6 weeks
Change in pain intensity	Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)	6 weeks
Change in interest in sexual activity	Mean difference in interest in sexual activity score as assessed by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal clinically important difference (MCID) in feelings of anxiety	Likelihood of achieving a MCID in anxiety, as measured by PROMIS Anxiety 4a (4-20; where lower scores indicate less anxiety).	6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety	Likelihood of achieving a MCID in anxiety, as measured by PROMIS Anxiety 8a (8-40; where lower scores indicate less anxiety).	6 weeks
Minimal clinically important difference (MCID) in feelings of depression	Likelihood of achieving a MCID in depression , as measured by PROMIS Depression 4a (4-20; where lower scores indicate less depression).	6 weeks
Minimal clinically important difference (MCID) in feelings of depression	Likelihood of achieving a MCID in depression , as measured by PROMIS Depression 8a (8-40; where lower scores indicate less depression).	6 weeks
Minimal clinically important difference (MCID) in cognitive function	Likelihood of achieving a MCID in cognitive function , as measured by PROMIS cognitive function 4a (4-20; where lower scores indicate poorer cognitive function).	6 weeks
Minimal clinically important difference (MCID) in cognitive function	Likelihood of achieving a MCID in cognitive function , as measured by PROMIS cognitive function 8a (8-40; where lower scores indicate poorer cognitive function).	6 weeks
Minimal clinically important difference (MCID) in sleep disturbance	Likelihood of achieving a MCID in sleep disturbance , as measured by PROMIS Sleep Disturbance 4a (4-20; where lower scores indicate less sleep disturbance).	6 weeks
Minimal clinically important difference (MCID) in sleep disturbance	Likelihood of achieving a MCID in sleep disturbance , as measured by PROMIS Sleep Disturbance 8a (8-40; where lower scores indicate less sleep disturbance).	6 weeks
Minimal clinically important difference (MCID) in fatigue	Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 4a (4-20; where lower scores indicate less fatigue).	6 weeks
Minimal clinically important difference (MCID) in fatigue	Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 8a (8-40; where lower scores indicate less fatigue).	6 weeks
Minimal clinically important difference (MCID) in pain interference	Likelihood of achieving a MCID in pain interference, as measured by PROMIS Pain interference (6-30; where lower scores indicate less pain interference).	6 weeks
Minimal clinically important difference (MCID) in pain intensity	Likelihood of achieving a MCID in pain intensity, as measured by PROMIS Pain intensity (3-15; where lower scores indicate less pain intensity).	6 weeks
Minimal clinically important difference (MCID) in interest in sexual function	Likelihood of achieving a MCID in interest in sexual activity, as measured by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)	6 weeks
Change in other menopausal health issues	Other menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 10 - 48; where higher is more severe menopausal health issues)	6 weeks

Collaborators and Investigators

• Sponsor: Radicle Science

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Purinergic Antagonists; Purinergic Agents; Central Nervous System Stimulants; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Caffeine
• Other Study ID Numbers: RADX-P-2414

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