A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes.
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 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
450
Participants will use their GI Health Placebo Control as directed for a period of 6 weeks.
Participants will use their GI Health Active Product as directed for a period of 6 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in GI-related QoL (DQLQ)
Difference between rates of change over time in DQLQ score as assessed by Digestion-associated QoL (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
Time frame: 7 weeks
Change in Gas and Bloating
Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-60; where the higher scores correspond to worse gas and bloating)
Time frame: 7 weeks
Change in Constipation
Difference between rates of change over time in constipation score as assessed by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)
Time frame: 7 weeks
Change in Diarrhea
Difference between rates of change over time in diarrhea score as assessed by PROMIS Diarrhea 6A (scale 2-30; where the higher scores correspond to worse diarrhea)
Time frame: 7 weeks
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