A randomized, double-blinded, placebo-controlled study assessing the impact of health and wellness products on feeling of anxiety, stress, and other health outcomes
This is a randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for less anxiety or stress, (2) indicate an interest in taking a health and wellness product to potentially help their feelings of anxiety 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 report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data are collected electronically from eligible participants over 7 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
3,853
Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.
Participants will use their Radicle Calm Active Study Product 1.2 as directed for a period of 6 weeks.
Participants will use their Radicle Calm Active Study Product 1.3 as directed for a period of 6 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: 6 weeks
Change in stress
Mean difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress)
Time frame: 6 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: 6 weeks
Change in sleep
Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)
Time frame: 6 weeks
Change in mood (emotional distress)
Mean difference in mood score as assessed by PROMIS Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)
Time frame: 6 weeks
Change in libido
Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where lower scores correspond to less interest in sexual activity)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Participants will use their Radicle Calm Active Study Product 2.1 as directed for a period of 6 weeks.
Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
Participants will use their Radicle Calm Active Study Product 3.1 as directed for a period of 6 weeks.
Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
Participants will use their Radicle Calm Active Study Product 4.1 as directed for a period of 6 weeks.
Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)
Time frame: 6 weeks