Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health

Radicle Science1,494 enrolled

Overview

A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data will be collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during 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

1,494

Conditions

Sleep Pain Depression Anxiety

Interventions

Placebo Control Form 1 CapsulesDIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.

Health Active Study Product 1.1 CapsulesDIETARY_SUPPLEMENT

Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.

Health Active Study Product 1.2 CapsulesDIETARY_SUPPLEMENT

Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * 21 years of age and older * Resides in the United States * Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue) * Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity until the end of the study Exclusion Criteria: * Reports being pregnant, trying to become pregnant, or breastfeeding * Unable to provide a valid physical shipping address and mobile phone number * Reports a diagnosis of liver or kidney disease * Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * Reports current enrollment in a clinical trial * The QOL score greater than 5 during enrollment * Unable to read and understand English * Lack of reliable daily access to the internet * Reports taking any medication that warns against grapefruit consumption * Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Locations (1)

Radicle Science, Inc

Del Mar, California, United States

Outcomes

Primary Outcomes

Change in overall health-related quality of life

Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)

Time frame: 4 weeks

Secondary Outcomes

Change in physical function

Mean difference in physical function score as assessed by PROMIS PROPr items related to physical function (scale 4-20; with higher scores corresponding to greater physical function)

Time frame: 4 weeks

Change in feelings of anxiety

Mean difference in feelings of anxiety score as assessed by PROMIS PROPr items related to anxiety (scale 4-20; with higher scores corresponding to more severe feelings of anxiety)

Time frame: 4 weeks

Change in feelings of depression

Mean difference in feelings of depression score as assessed by PROMIS PROPr items related to depression (scale 4-20; with higher scores corresponding to more severe feelings of depression)

Time frame: 4 weeks

Change in fatigue

Mean difference in fatigue score as assessed by PROMIS PROPr questions related to fatigue (scale 4-20; with higher scores corresponding to more severe fatigue)

Time frame: 4 weeks

Change in sleep disturbance

Mean difference in sleep disturbance score as assessed by PROMIS PROPr items related to sleep disturbance (scale 4-20; with higher scores corresponding to greater sleep disturbance)

Data from ClinicalTrials.gov

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