[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07713810":3,"trial-entities:NCT07713810":98,"trial-summary:NCT07713810":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":62,"locations":65,"central_contacts":84,"overall_officials":90,"references":93,"see_also_links":94},"NCT07713810","RADX_P_2604_VNB","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","NOT_YET_RECRUITING","2027-07-16","2026-07","2026-07-20","2026-07-16","Radicle Science","INDUSTRY",false,"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","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.\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. Self-reported data are collected electronically from eligible participants for 5 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.",[19],"Constipation",[],"INTERVENTIONAL","OTHER",[24],"NA",{"count":26,"type":27},550,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIETARY_SUPPLEMENT","Placebo GI Health Control","Participants will use their Placebo GI Health Control product as directed for a period of 4 weeks",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Active GI Health Product","Participants will use their Active GI Health Product as directed for a period of 4 weeks",[38],"Active GI Health Product 1",[40],{"measure":41,"description":42,"timeFrame":43},"Change in Constipation","Change in Constipation: Difference between rates of change over time in constipation score as assessed by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)","5 weeks",[45,48,51],{"measure":46,"description":47,"timeFrame":43},"Change in Gas and Bloating","Change in Gas and Bloating: Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)",{"measure":49,"description":50,"timeFrame":43},"Change in GI-related Quality of Life (QOL)","Change in GI-related Quality of Life (QOL): Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)",{"measure":52,"description":53,"timeFrame":43},"Change in the severity of gastrointestinal symptoms","Change in the severity of gastrointestinal symptoms: Difference between rates of change over time in gastrointestinal symptoms score as assessed by GSRS (scale 7-105; with higher scores equaling greater severity)","ALL","21 Years","105 Years",true,{"inclusion":59,"exclusion":60,"raw_text":61},[],[],"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",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":81},"Radicle Science Inc.","Del Mar","California","92014-2605","United States",[73,78],{"name":74,"role":75,"phone":76,"email":77},"Study Manager","CONTACT","760-281-3898","studymgmt@radiclescience.com",{"name":79,"role":75,"email":80},"Megan Moseley","megan@radiclescience.com",{"lat":82,"lon":83},32.95949,-117.26531,[85,87],{"name":74,"role":75,"phone":86,"email":77},"858-779-0086",{"name":88,"role":75,"phone":76,"email":89},"Susan Hewlings","susan.hewlings@radiclescience.com",[91],{"name":88,"affiliation":13,"role":92},"PRINCIPAL_INVESTIGATOR",[],[95],{"label":96,"url":97},"Related Info","https:\u002F\u002Fwww.radiclescience.com",{"nct_id":4,"conditions":99,"biomarkers":100},[19],[],{"nct_id":4,"found":57,"summary":102,"prompt_version":112},{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is a randomized, double-blind, placebo-controlled study with 550 planned participants. This means participants will be randomly assigned to receive either the active product or a placebo, and neither you nor the study staff will know which one you are taking until the study ends.","completed","Radicle GI HealthTM VNB: A Study on Constipation and Health Products","This study is looking at how two health and wellness products, a \"Placebo GI Health Control\" and an \"Active GI Health Product,\" might affect constipation. You could be eligible if you are an adult (age 21 to 105) living in the United States and have constipation that could improve by at least 30%. The study wants to see if these products can reduce constipation over 5 weeks. This study is currently unclear on its recruitment status, but plans to enroll 550 people. It's a \"direct-to-consumer\" study, meaning you won't have in-person visits.","Your constipation will be measured at 5 weeks after starting the study.",92,"You would use your assigned product as directed for 4 weeks. All study assessments, including health indicator reports, will be collected electronically for 5 weeks.","Not stated in the trial record.",[31,35],"v2"]