An interventional study of Relaxation Placebo Control and Relaxation Active Product 1 in Stress, sponsored by Radicle Science. Completed at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-03.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
A randomized, double-blind, placebo controlled direct-to-consumer study assessing the impact of health and wellness products on stress 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.
Radicle Science is the lead sponsor of 64 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities o Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
Exclusion Criteria:
Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
o NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
Relaxation Product Form - Control
Dietary Supplement: Relaxation Placebo Control
Relaxation Product Form - Active 1
Dietary Supplement: Relaxation Active Product 1
Relaxation Product Form - Active 2
Dietary Supplement: Relaxation Active Product 2
Participants will use their Relaxation Placebo Control as directed for a period of 6 weeks.
Participants will use their Relaxation Active Product 1 as directed for a period of 6 weeks.
Participants will use their Relaxation Active Product 2 as directed for a period of 6 weeks.
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: 7 weeks
Minimal clinical importance difference (MCID) in perceived stress
Likelihood of achieving a MCID in perceived stress, as measured by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)
Time frame: 7 weeks
Change in feelings of anxiety
Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; where the higher scores correspond to worse feelings of anxiety)
Time frame: 7 weeks
Change in mood
Difference between rates of change over time in mood score as assessed by PROMIS Depression 4A (scale 4-20; where the higher scores correspond to worse mood)
Time frame: 7 weeks
Change in cognitive function
Difference between rates of change over time in mood score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where the higher scores correspond to better cognitive function)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in cognitive function
Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function 4A (scale 4-20; where the higher scores correspond to better cognitive function)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in feelings of anxiety
Likelihood of achieving a MCID in feelings of anxiety, as measured by PROMIS Anxiety 4A (scale 4-20; where the higher scores correspond to worse feelings of anxiety)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in mood
Likelihood of achieving a MCID in mood, as measured by PROMIS Depression 4A (scale 4-20; where the higher scores correspond to worse mood)
Time frame: 7 weeks
Change in sleep disturbance
Difference between rates of change over time in sleep disturbance score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; where the higher scores correspond to worse sleep disturbance)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in sleep disturbance
Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance 4A (scale 4-20; where the higher scores correspond to worse sleep disturbance)
Time frame: 7 weeks
Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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