Radicle Relief RAL: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on pain relief 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 8 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
650
Participants will use their Pain Relief Supplement Product Placebo Control as directed for a period of 8 weeks
Participants will use their Pain Relief Supplement Active Product 1 as directed for a period of 8 weeks
Radicle Science Inc.
Del Mar, California, United States
Change in Pain Interference
Change in Pain Interference: Difference in rates of change over time in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)
Time frame: 9 weeks
Change in Pain Intensity
Change in Pain Intensity: Difference in rates of change over time in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)
Time frame: 9 weeks
Change in sleep
Change in sleep: 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)
Time frame: 9 weeks
Change in Physical Function
Change in physical function: Difference in rates of change over time in physical function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Physical Function 8C (scale 8-40; where higher scores correspond to better physical function)
Time frame: 9 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.