A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety 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
500
Participants will use their Calm Product Placebo Control as directed for a period of 6 weeks.
Participants will use their Calm Active Product 1 as directed for a period of 6 weeks.
Radicle Science Inc.
Del Mar, California, United States
Change in feelings of anxiety
Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Time frame: 7 weeks
Change in feelings of stress
Change in feelings of stress: Difference between rates of change over time in feelings of stress score as assessed Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)
Time frame: 7 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: 7 weeks
Change in mood (emotional distress-depression)
Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)
Time frame: 7 weeks
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