A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on menstrual wellness in premenopausal women
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 premenopausal, (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
850
Participants will use their Menstrual Wellness Product Placebo Control as directed for a period of 12 weeks
Participants will use their Menstrual Wellness Product 1 as directed for a period of 12 weeks
Radicle Science Inc.
Del Mar, California, United States
Change in Menstrual Distress
Difference between rates of change over time in Menstrual Distress as assessed by MEDI-Q (scale 0-125; higher scores = worse menstrual distress)
Time frame: 13 weeks
Change in Wellbeing
Difference between rates of change over time in Wellbeing as assessed by WHO-5 (scale 0-25; higher scores = better wellbeing)
Time frame: 13 weeks
Change in Pain Interference
Difference in rates of change over time in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)
Time frame: 13 weeks
Change in Pain Intensity
Difference in rates of change over time in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)
Time frame: 13 weeks
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