A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on perimenopausal women's self-reported health issues and outcomes
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants (1) are female, (2) are perimenopausal, (3) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (4) express acceptance in taking study products and not knowing the formulation identities 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 women who 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 13 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 Revive Product Form - Placebo Control as directed for a period of 12 weeks.
Participants will use their Revive Product Form - Active as directed for a period of 12 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in menopausal health issues
Difference between rates of change over time in menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)
Time frame: 13 weeks
Change in feelings of anger
Difference between rates of change over time in anger score as assessed by PROMIS Anger 5A (scale 5-25; with higher scores corresponding to more severe anger)
Time frame: 13 weeks
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: 13 weeks
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: 13 weeks
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