[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649199":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":67,"collaborators":26,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":26,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combination Therapy","EXPERIMENTAL","Vonoprazan + Itopride. Participants will receive vonoprazan 20 mg orally once daily (preferably in the morning) for 12 weeks, plus itopride 50 mg orally thrice daily before meals for 12 weeks. The vonoprazan dose of 20 mg daily is chosen as it is the standard dose shown to provide potent acid suppression for FD and related conditions. The itopride dose of 150mg\u002Fday is the recommended dosage for dyspepsia based on prior clinical trials and is expected to improve gastric emptying and reduce postprandial distress symptoms without significant systemic side effects",[13],"Drug: Vonoprazan plus Itopride combination",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group (Monotherapy)","ACTIVE_COMPARATOR","Participants receive:\n\n• Vonoprazan 20 mg orally once daily for 12 weeks. Purpose: Assess the effectiveness of vonoprazan monotherapy in relieving functional dyspepsia symptoms.",[19],"Drug: Vonoprazan",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Vonoprazan plus Itopride combination","Participants will receive vonoprazan 20 mg orally once daily (preferably in the morning) for 12 weeks, plus itopride 50 mg orally thrice daily before meals for 12 weeks. The vonoprazan dose of 20 mg daily is chosen as it is the standard dose shown to provide potent acid suppression",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Vonoprazan","Participants will receive vonoprazan 20 mg orally once daily for 12 weeks",[15],[32],{"name":33,"affiliation":34,"role":35},"Dr.Mohan Kumar Ramchandani, MD, DM","AIG Hospitals","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Dr.Aniruddha Pratap singh, MD, DM","CONTACT","9004093248","Doc.aniruddha85@gmail.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Asian Institute of Gastroenterology\u002FAIG Hospitals","RECRUITING","Hyderabad","Telangana","500082","India","IN",{"type":52,"coordinates":53},"Point",[54,55],78.45636,17.38405,{"lat":55,"lon":54},[58,63],{"name":59,"role":39,"phone":60,"phoneExt":61,"email":62},"Dr Mohan Ramchandani, MBBS MD DM","04023378888","802","ramchandanimohan@gmail.com",{"name":64,"role":39,"phone":65,"phoneExt":26,"email":66},"Dr SHASHEENDRA YANAGANDULA, MBBS MS","9676050769","shasheendra8@gmail.com",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mohan Ramchandani","Principal Investigator","100649199","vonoprazan-alone-vs-with-itopride-for-functional-dyspepsia-the-viva-trial-100649199",false,"NCT07731542","Vonoprazan Alone vs With Itopride for Functional Dyspepsia: The VIVA Trial","A Randomized Controlled Trial of Vonoprazan Monotherapy Versus Vonoprazan-Itopride Combination Therapy in Functional Dyspepsia (VIVA Trial)","Inclusion Criteria:\n\n1. Confirmed Functional Dyspepsia (FD): As per Rome IV criteria: Symptoms for ≥3 days\u002Fweek over the last 3 months.\n2. Prior endoscopy with normal findings or minor gastritis within the last 3 months.\n3. Negative Helicobacter pylori test (Rapid urease test) or urea breath test\n4. The patient should be off Proton pump inhibitors for 2 weeks\n\nExclusion Criteria:\n\n1. Evidence of structural\u002Fbiochemical issues like peptic ulcer, erosive esophagitis, gastric\u002Fesophageal malignancy, pancreato-biliary disorders Overlapping functional GI Disorders: IBS\n2. Uncontrolled systemic diseases (e.g., uncontrolled diabetes), major psychiatric disorders (e.g., severe depression), or neurological disorders affecting Gastrointestinal motility.\n3. Use of medications that affect gastrointestinal motility or symptom perception (e.g., chronic opioid analgesics, anticholinergic drugs, benzodiazepines).\n4. Pregnancy or Lactation\n5. History of Consumption of alcohol or smoking","ALL","20 Years","50 Years",{"count":82,"type":83},192,"ESTIMATED","INTERVENTIONAL",[86],"NA","The VIVA trial is a 12-week, randomized, interventional study comparing vonoprazan monotherapy versus vonoprazan plus itopride combination therapy in adults with functional dyspepsia (FD). FD is a common digestive disorder causing upper stomach discomfort, fullness after meals, and early satiety.\n\nThe study aims to determine if adding itopride, a prokinetic that improves stomach emptying, to vonoprazan, a strong acid-suppressing drug, provides better symptom relief than vonoprazan alone. Participants will be randomly assigned to receive either treatment, and their symptoms, quality of life, and safety outcomes will be monitored throughout the study.\n\nThe trial will help guide the best management strategy for FD by targeting both acid-related and motility-related symptoms.",[89],"Functioanl Dyspepsia","2026-07-25",{"date":92,"type":93},"2026-07-28","ACTUAL",{"date":95,"type":93},"2026-01-10",{"date":97,"type":83},"2027-02-10",{"name":5,"class":6},1]