A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Trial Assessing the Impact of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women with Peri-Menopausal Health Issues
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants (1) are females, (2) have peri-menopausal-related health issues for 3 months or longer, (3) have the opportunity to improve by at least 30% in the primary 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 ag who are 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
500
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Participants will use their Radicle Revive Active Study Product 1 as directed for a period of 6 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in Perceived Stress
Change in perceived stress: Difference between rates of change over time in Perceived Stress score as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)
Time frame: 6 weeks
Change in General Menopausal Health
Change in other menopausal health issues: Other 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: 6 weeks
Change in Sleep Disturbance
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: 6 weeks
Change in Fatigue
Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in perceived stress
Likelihood of experiencing minimal clinically important difference in perceived stress, as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in menopausal health issues
Likelihood of experiencing minimal clinically important difference in menopausal health issues score assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)
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Time frame: 7 weeks
Minimal clinically important difference (MCID) in fatigue
Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Time frame: 7 weeks
Minimal clinically important difference (MCID) in sleep
Likelihood of experiencing minimal clinically important difference 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: 7 weeks