Radicle Relaxation™ CIX: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
Resides in the United States
Has the opportunity for at least 30% improvement in their primary health outcome
None
Parallel
Placebo Relaxation Control
Dietary supplementParticipants will use their Placebo Relaxation Control as directed for a period of 8 weeks
Active Relaxation Product 1
Dietary supplementParticipants will use their Active Relaxation Product 1 as directed for a period of 8 weeks
Change in feelings of stress
Change in feelings of stress: Difference between rates of change over time in feelings of stress score as assessed Perceived Stress Scale 10 (PSS-10) (scale 1-5; where lower scores correspond to less stress)
Change in feelings of anxiety
Change in feelings of anxiety: Difference in rates of change over time in feelings of anxiety assessed by General Anxiety Disorder (GAD-7) (scale 0-3; where higher scores correspond to greater feelings of anxiety)
Change in sleep
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)
Change in mood (emotional distress-depression)
Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)
Minimal clinically important difference (MCID) in feelings of stress
Minimal clinically important difference (MCID) in feelings of stress: Likelihood of experiencing minimal clinically important difference in feelings of stress as assessed by Perceived Stress Scale (PSS-10) (scale 1-5; where lower scores correspond to less stress)
Minimal clinically important difference in feelings of anxiety
Minimal clinically important difference in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety as assessed by General Anxiety Disorder (GAD-7) (scale 0-3; where higher scores correspond to greater feelings of anxiety)
Minimal clinically important difference (MCID) in sleep
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)
Minimal clinically important difference (MCID) in mood (emotional distress-depression)
Minimal clinically important difference (MCID) in mood (emotional distress-depression): Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
