Radicle Clarity DSTTM: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on mental clarity and related health outcomes.
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, and (2) express acceptance in taking a product and not knowing its formulation 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 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 12 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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
990
Participants will use their Clarity Product Placebo Control as directed for a period of 12 weeks.
Participants will use their RS Clarity Active Product as directed for a period of 12 weeks
Radicle Science Inc.
Del Mar, California, United States
RECRUITINGChange in cognitive function
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)
Time frame: 13 weeks
Change in fatigue
Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Time frame: 13 weeks
Change in sleep-related impairment
Change in sleep-related impairment: Difference between rates of change over time in sleep score as assessed by PROMIS Sleep-Related Impairment 8a (scale 8-40; where the higher scores correspond to worse sleep)
Time frame: 13 weeks
Change in cognitive abilities
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)
Time frame: 13 weeks
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