[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647826":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":61,"collaborators":23,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":23,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":23,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":23,"overallStatus":44,"whyStopped":23,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Radicle Science","INDUSTRY",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Active GI Health Product 1","EXPERIMENTAL",[12],"Dietary Supplement: Active GI Health Product",{"label":14,"type":15,"description":14,"interventionNames":16},"Placebo GI Health Control","PLACEBO_COMPARATOR",[17],"Dietary Supplement: Placebo GI Health Control",[19,24],{"type":20,"name":14,"description":21,"armGroupLabels":22,"otherNames":23},"DIETARY_SUPPLEMENT","Participants will use their Placebo GI Health Control product as directed for a period of 4 weeks",[14],null,{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Active GI Health Product","Participants will use their Active GI Health Product as directed for a period of 4 weeks",[9],[29],{"name":30,"affiliation":5,"role":31},"Susan Hewlings","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":23,"email":37},"Study Manager","CONTACT","858-779-0086","studymgmt@radiclescience.com",{"name":30,"role":35,"phone":39,"phoneExt":23,"email":40},"760-281-3898","susan.hewlings@radiclescience.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Radicle Science Inc.","RECRUITING","Del Mar","California","92014-2605","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-117.26531,32.95949,{"lat":54,"lon":53},[57,58],{"name":34,"role":35,"phone":39,"phoneExt":23,"email":37},{"name":59,"role":35,"phone":23,"phoneExt":23,"email":60},"Megan Moseley","megan@radiclescience.com",{"type":62,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100647826","radicle-gi-healthtm-vnb-a-study-assessing-the-impact-of-health-and-wellness-products-on-constipation-and-related-health-outcomes-100647826",false,"NCT07713810","Radicle GI HealthTM VNB: A Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes","Radicle GI HealthTM VNB: A Randomized, Double-Blind, Placebo- Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes","3.1 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\n3.2 Exclusion\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\n  * Reports taking any product for acute constipation\n  * Reports taking any medications containing levodopa\n* Lack of reliable daily access to the internet",true,"ALL","21 Years","105 Years",{"count":75,"type":76},550,"ESTIMATED","INTERVENTIONAL",[79],"NA","Radicle GI HealthTM VNB: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on constipation and related health outcomes",[82],"Constipation","2026-08-18",{"date":85,"type":86},"2026-08-20","ACTUAL",{"date":88,"type":86},"2026-07-30",{"date":90,"type":76},"2027-07-16",{"name":5,"class":6},1]