A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on overall health
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 up to 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 Radicle Health Control Study Product as directed for a period of 6 weeks.
Participants will use their Radicle Health Active Study Product as directed for a period of 6 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in overall health profile
Difference between rates of change over time in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in overall health-related quality of life
Likelihood of achieving a MCID in overall health-related quality of life, as measured by PROMIS PROPr (scale 70-120; with higher scores corresponding to greater overall health-related quality of life)
Time frame: 7 weeks
Change in sexual health
Difference between rates of change over time in sexual health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Brief Profile Sexual Function and Satisfaction Survey (where lower scores correspond to lower sexual function and satisfaction)
Time frame: 7 weeks
Change in GI-related Quality of Life (QOL)
Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
Time frame: 7 weeks
Change in mood (emotion distress-depression)
Difference between rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Time frame: 7 weeks
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Minimal clinically important difference (MCID) in GI-related QOL
Likelihood of experiencing minimal clinically important difference in GI-related QOL score as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in mood (emotional distress-depression)
Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in sexual health
Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Brief Profile Sexual Function and Satisfaction Survey (where lower scores correspond to lower sexual function and satisfaction)
Time frame: 7 weeks