A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety, stress and other health outcomes
This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for less feelings of anxiety and/or stress, (2) indicate an interest in taking a health and wellness product to potentially improve their anxiety and/or stress, 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 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
1,211
Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks.
Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.
Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in feelings of anxiety
Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)
Time frame: 4 weeks
Minimal clinically important difference (MCID) in anxiety
Likelihood of experiencing a MCID in anxiety score as assessed by PROMIS Anxiety 8A
Time frame: 4 weeks
Change in stress
Mean difference in stress score as assessed by PROMIS Stress 8A (scale 8-40; where lower scores correspond to less stress)
Time frame: 4 weeks
Minimal clinically important difference (MCID) in stress
Likelihood of experiencing a MCID in stress score as assessed by PROMIS Stress 8A
Time frame: 4 weeks
Change in sleep disturbance
Mean difference in sleep disturbance score as assessed by PROMIS Sleep 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)
Time frame: 4 weeks
Change in cognitive function
Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)
Time frame: 4 weeks
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Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks.
Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks.