[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657194":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":60,"overallOfficials":68,"centralContacts":72,"locations":81,"responsibleParty":100,"collaborators":41,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":41,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":41,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":41,"overallStatus":122,"whyStopped":41,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Radicle Science","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"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)","9 weeks",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"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)",{"measure":18,"description":19,"timeFrame":12},"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)",{"measure":21,"description":22,"timeFrame":12},"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)",[24,27,30,33],{"measure":25,"description":26,"timeFrame":12},"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)",{"measure":28,"description":29,"timeFrame":12},"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)",{"measure":31,"description":32,"timeFrame":12},"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)",{"measure":34,"description":35,"timeFrame":12},"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)",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":41,"timePerspective":41,"maskingInfo":42},"RANDOMIZED","PARALLEL","Eligible participants who complete all required enrollment steps will be stratified using a sequential randomization model designed to support balanced allocation across study product groups. Stratification will be based on sex at birth (Female or Non-Female), age (21-44, 45-64, or 65+), biospecimen collection (Yes or No), and health outcome score, with categories and thresholds determined according to the applicable scoring guidelines. Participants will then be randomized sequentially based on all stratification factors collectively to promote an even distribution of participant characteristics across the study product groups. Following randomization, participants will receive their assigned study product along with an insert containing additional information regarding product use and study procedures.","OTHER",null,{"masking":43,"maskingDescription":44,"whoMasked":45},"DOUBLE","The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.",[46,47],"PARTICIPANT","INVESTIGATOR","This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.\n\nEligible 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.\n\nParticipants 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.\n\nSelf-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.",[50,55],{"label":51,"type":52,"description":51,"interventionNames":53},"Active Relaxation Product 1","EXPERIMENTAL",[54],"Dietary Supplement: Active Relaxation Product 1",{"label":56,"type":57,"description":56,"interventionNames":58},"Placebo Relaxation Control","PLACEBO_COMPARATOR",[59],"Dietary Supplement: Placebo Relaxation Control",[61,65],{"type":62,"name":56,"description":63,"armGroupLabels":64,"otherNames":41},"DIETARY_SUPPLEMENT","Participants will use their Placebo Relaxation Control as directed for a period of 8 weeks",[56],{"type":62,"name":51,"description":66,"armGroupLabels":67,"otherNames":41},"Participants will use their Active Relaxation Product 1 as directed for a period of 8 weeks",[51],[69],{"name":70,"affiliation":5,"role":71},"Susan Hewlings","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":41,"email":77},"Study Manager","CONTACT","858-779-0086","studymgmt@radiclescience.com",{"name":70,"role":75,"phone":79,"phoneExt":41,"email":80},"760-281-3898","susan.hewlings@radiclescience.com",[82],{"facility":83,"status":41,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Radicle Science, Inc","Del Mar","California","92014","United States","US",{"type":90,"coordinates":91},"Point",[92,93],-117.26531,32.95949,{"lat":93,"lon":92},[96,97],{"name":74,"role":75,"phone":79,"phoneExt":41,"email":77},{"name":98,"role":75,"phone":41,"phoneExt":41,"email":99},"Megan Moseley","megan@radiclescience.com",{"type":101,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100657194","radicle-relaxation-cix-a-study-assessing-the-impact-of-health-and-wellness-products-on-stress-and-related-health-outcomes-100657194",false,"NCT07835997","Radicle Relaxation™ CIX: A Study Assessing the Impact of Health and Wellness Products on Stress and Related Health Outcomes","Radicle Relaxation™ CIX: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Stress and Related Health Outcomes","Inclusion\n\nParticipants must meet all the following criteria:\n\n* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities\n\n  * Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed\n* Resides in the United States\n* Has the opportunity for at least 30% improvement in their primary health outcome\n* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study\n\nExclusion\n\nIndividuals who report any of the following during screening may be excluded from participation:\n\n* Report being pregnant, trying to become pregnant, or breastfeeding\n* Unable to provide a valid US shipping address and mobile phone number\n* Reports current enrollment in another clinical trial\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)\n* Unable to read and understand English at a 7th grade level\n* Reports a current and\u002For recent (up to 3 months ago) major illness and\u002For surgery that poses a known, significant safety risk.\n* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and\u002For a significant safety risk with any of the study product ingredients.\n\n  * 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\n* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.\n\n  * Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products\n* Reports current use of the primary ingredient(s) and\u002For similar product(s) to the active study product(s) that may limit the effects of the study products and\u002For pose a safety risk\n* Lack of reliable daily access to the internet\n* 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.\n\n  * To ensure compliance, state-of-residence logic is built into the enrollment platform. Participants who indicate a residential address in New York, New Jersey, or Rhode Island will not be presented with the biomarker collection consent or any associated study materials. This automated screening ensures that ineligible participants are not inadvertently enrolled in the collection. These participants will otherwise proceed through full main study enrollment and participation without interruption.",true,"ALL","21 Years","105 Years",{"count":114,"type":115},550,"ESTIMATED","INTERVENTIONAL",[118],"NA","Radicle Relaxation™ CIX: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes",[121],"Stress","NOT_YET_RECRUITING","2026-09-17",{"date":125,"type":126},"2026-09-23","ACTUAL",{"date":123,"type":115},{"date":129,"type":115},"2027-09-17",{"name":5,"class":6},1]