[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549212":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":36,"locations":54,"responsibleParty":68,"collaborators":36,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":36,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":36,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":36,"overallStatus":91,"whyStopped":36,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Radicle Science","INDUSTRY",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Control 1","PLACEBO_COMPARATOR","Calm Product Form 1 - control",[13],"Dietary Supplement: Placebo Control Form 1",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Product 1.1","EXPERIMENTAL","Calm Product Form 1 - active product 1",[19],"Dietary Supplement: Calm Active Study Product 1.1 Usage",{"label":21,"type":10,"description":22,"interventionNames":23},"Placebo Control 6.1.0","Calm Product 6.1 - control",[24],"Dietary Supplement: Placebo Control 6.1",{"label":26,"type":16,"description":27,"interventionNames":28},"Active Product 6.1.1","Calm Product 6.1 - active product 1",[29],"Dietary Supplement: Calm Active Study Product 6.1 Usage",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DIETARY_SUPPLEMENT","Placebo Control Form 1","Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Calm Active Study Product 1.1 Usage","Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.",[15],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Placebo Control 6.1","Participants will use their Placebo Control 6.1 as directed for a period of 6 weeks.",[21],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Calm Active Study Product 6.1 Usage","Participants will use their Radicle Calm Active Study Product 6.1 as directed for a period of 6 weeks.",[26],[50],{"name":51,"affiliation":52,"role":53},"Emily K. Pauli, PharmD","Radicle Science Inc.","PRINCIPAL_INVESTIGATOR",[55],{"facility":56,"status":36,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":36},"Radicle Science, Inc","Del Mar","California","92014","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-117.26531,32.95949,{"lat":66,"lon":65},{"type":69,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100549212","radicle-calm-24-a-study-of-health-and-wellness-products-on-feelings-of-anxiety-and-related-health-outcomes-100549212",false,"NCT06431074","Radicle Calm 24: A Study of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes","Radicle Calm™ 24: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes","Inclusion Criteria:\n\n* Adults, at least 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and\u002For gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed\n* Resides in the United States\n* Endorses less anxiety as a primary desire\n* Has the opportunity for at least 20% 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 Criteria:\n\n* Reports 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\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. NYHA (New York Heart Association) Class Ill 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. Anticoagulants, antihypertensive, 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, MAOls (monoamine oxidase inhibitors), or thyroid products\n* Reports current use of the primary ingredient(s) and\u002For similar product(s) to the active study product(s)\n* Lack of reliable daily access to the internet",true,"ALL","21 Years","105 Years",{"count":82,"type":83},502,"ACTUAL","INTERVENTIONAL",[86],"NA","A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes",[89,90],"Anxiety","Stress","COMPLETED","2025-08-11",{"date":94,"type":83},"2025-08-14",{"date":96,"type":83},"2024-05-30",{"date":92,"type":83},{"name":5,"class":6},1]