Radicle GI HealthTM VNB: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on constipation 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 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 5 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. 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
550
Participants will use their Placebo GI Health Control product as directed for a period of 4 weeks
Participants will use their Active GI Health Product as directed for a period of 4 weeks
Radicle Science Inc.
Del Mar, California, United States
RECRUITINGChange in Constipation
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: 5 weeks
Change in Gas and Bloating
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 3-59; where the higher scores correspond to worse gas and bloating)
Time frame: 5 weeks
Change in GI-related Quality of Life (QOL)
Change in GI-related Quality of Life (QOL): Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
Time frame: 5 weeks
Change in the severity of gastrointestinal symptoms
Change in the severity of gastrointestinal symptoms: Difference between rates of change over time in gastrointestinal symptoms score as assessed by GSRS (scale 7-105; with higher scores equaling greater severity)
Time frame: 5 weeks
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