An interventional study of Placebo Relaxation Control and Active Relaxation Product 1 in Stress, sponsored by Radicle Science. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Radicle Science · Not applicable, Interventional, and Other
Radicle Relaxation™ CIX: 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) 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 9 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.
Radicle Science is the lead sponsor of 66 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all the following criteria:
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Exclusion
Individuals who report any of the following during screening may be excluded from participation:
Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known and/or a significant safety risk with any of the study product ingredients.
Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
Participants residing in the states of New York, New Jersey, or Rhode Island are eligible to enroll in the main study and will complete all primary study activities. However, these participants are not eligible to participate in the biomarker collection. This restriction is due to state regulatory requirements governing direct-to-consumer at-home laboratory specimen collection and processing that cannot be accommodated within the fully decentralized design of the biomarker collection. No alternative collection pathway is available under the current protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active Relaxation Product 1
Dietary Supplement: Active Relaxation Product 1
Placebo Relaxation Control
Dietary Supplement: Placebo Relaxation Control
Participants will use their Placebo Relaxation Control as directed for a period of 8 weeks
Participants 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)
Time frame: 9 weeks
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)
Time frame: 9 weeks
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)
Time frame: 9 weeks
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)
Time frame: 9 weeks
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)
Time frame: 9 weeks
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)
Time frame: 9 weeks
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)
Time frame: 9 weeks
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)
Time frame: 9 weeks
Plan to share: No — Data will not be shared with researchers outside of Radicle Collaborators on this study.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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