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

Radicle Science500 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

500

Conditions

Menopause Sleep Disturbance Anxiety Depression Cognitive Function Fatigue Libido

Interventions

Radicle Revive Placebo Control Form 4.1DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Radicle Revive Active Study Product 4.1 UsageDIETARY_SUPPLEMENT

Participants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 weeks.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 105 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Radicle Science, Inc

Del Mar, California, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 6 weeks

Data from ClinicalTrials.gov

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Secondary Outcomes

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)

Time frame: 6 weeks

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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)

Time frame: 6 weeks