An interventional study of Placebo Control Form 1 and Relaxation Active Study Product 1.1 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 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) endorse a desire for less stress (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) 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 over 7 weeks. Participant reports of health indicators will be collected during 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.
Exclusion Criteria:
Relaxation Product Form 1 - control
Dietary Supplement: Placebo Control Form 1
Relaxation Product Form 1 - active product 1
Dietary Supplement: Relaxation Active Study Product 1.1
Relaxation Product Form 2 - control
Dietary Supplement: Placebo Control Form 2
Relaxation Product Form 2 - active product 1
Dietary Supplement: Relaxation Active Study Product 2.1
Relaxation Product Form 3 - control
Dietary Supplement: Placebo Control Form 3
Relaxation Product Form 3 - active product 1
Dietary Supplement: Relaxation Active Study Product 3.1
Relaxation Product Form 4 - control
Dietary Supplement: Placebo Control Form 4
Relaxation Product Form 4 - active product 1
Dietary Supplement: Relaxation Active Study Product 4.1
Relaxation Product Form 4 - active product 2
Dietary Supplement: Relaxation Active Study Product 4.2
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Participants will use their Radicle Relaxation Active Study Product 1.1 as directed for a period of 6 weeks.
Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Participants will use their Radicle Relaxation Active Study Product 2.1 as directed for a period of 6 weeks.
Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
Participants will use their Radicle Relaxation Active Study Product 3.1 as directed for a period of 6 weeks.
Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
Participants will use their Radicle Relaxation Active Study Product 4.1 as directed for a period of 6 weeks.
Participants will use their Radicle Relaxation Active Study Product 4.2 as directed for a period of 6 weeks.
Change in stress
Mean difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress)
Time frame: 6 weeks
Change in feelings of anxiety
Mean difference in anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Time frame: 6 weeks
Change in cognitive function
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
Time frame: 6 weeks
Change in mood (emotional distress-depression)
Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in stress
Likelihood of experiencing minimal clinically important difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in feelings of anxiety
Likelihood of experiencing minimal clinically important difference in anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in cognitive function
Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
Time frame: 6 weeks
Minimal clinically important difference (MCID) in mood (emotional distress-depression)
Likelihood of experiencing minimal clinically important difference in emotional distress score as assessed by Patient Reported Outcome Measurement System (PROMIS) Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
Time frame: 6 weeks
Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool
Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only) Potentially include saliva (IgG, cytokines, DHEA-S, Estradiol, Progesterone, Testosterone, Cortisol, Melatonin, CRP) blood all in one panel 1 outcome (1 drop) (Cortisol, Homocysteine, Ferritin, TSH, HbA1c, Insulin, Vitamin D, DHEA-S, Testosterone, Estradiol, FSH, Total Cholesterol, HDL, LDL, Triglycerides, ApoA1, ApoB). Stool (microbial diversity). Values will vary based on optional biomarker selected
Time frame: 6 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 Jan 2025. You cannot join it, but the record below documents what was studied.
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