A randomized, double-blind, placebo controlled direct-to-consumer study assessing the impact of health and wellness products on stress 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 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
900
Participants will use their Relaxation Placebo Control as directed for a period of 6 weeks.
Participants will use their Relaxation Active Product 1 as directed for a period of 6 weeks.
Participants will use their Relaxation Active Product 2 as directed for a period of 6 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in perceived stress
Difference between rates of change over time in Perceived Stress score as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in perceived stress
Likelihood of achieving a MCID in perceived stress, as measured by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)
Time frame: 7 weeks
Change in feelings of anxiety
Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where the higher scores correspond to worse feelings of anxiety)
Time frame: 7 weeks
Change in mood
Difference between rates of change over time in mood score as assessed by PROMIS Depression 4A (scale 4-20; where the higher scores correspond to worse mood)
Time frame: 7 weeks
Change in cognitive function
Difference between rates of change over time in mood score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where the higher scores correspond to better cognitive function)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in cognitive function
Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function 4A (scale 4-20; where the higher scores correspond to better cognitive function)
Time frame: 7 weeks
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Minimal clinical importance difference (MCID) in feelings of anxiety
Likelihood of achieving a MCID in feelings of anxiety, as measured by PROMIS Anxiety 4A (scale 4-20; where the higher scores correspond to worse feelings of anxiety)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in mood
Likelihood of achieving a MCID in mood, as measured by PROMIS Depression 4A (scale 4-20; where the higher scores correspond to worse mood)
Time frame: 7 weeks