[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functioanl-dyspepsia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functioanl-dyspepsia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,75,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},192,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Functioanl Dyspepsia","RECRUITING","2026-07-25",{"date":31,"type":32},"2026-07-28","ACTUAL",{"date":34,"type":32},"2026-01-10",{"date":36,"type":21},"2027-02-10",{"name":38,"class":39},"Asian Institute of Gastroenterology, India","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":40},"100637154","phase-4-effect-of-digestive-enzymes-as-add-on-therapy-on-patients-with-functional-dyspepsia-100637154","NCT07578402","Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.","Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial","Inclusion Criteria:\n\n* Age 18 years or more\n* Patients with FD diagnosed according to ROME IV criteria\n\nExclusion Criteria:\n\n* Structural lesion in endoscopy and positive H. pylori status\n* History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease, thyroid disorders\n* Psychiatric disorders\n* Previous history gastrointestinal surgery\n* Any history of hypersensitivity, adverse effect, or ineffectiveness with digestive enzyme\n* Pregnancy and breastfeeding.",true,"18 Years","70 Years",{"count":52,"type":21},120,[54],"PHASE4","The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. The main questions it aims to answer are:\n\nDoes drug digestive enzymes has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug digestive enzymes? Researcher will compare drug digestive enzymes to a control group taking standard first line treatment only.\n\nParticipants will:\n\nTake drug digestive enzymes 325 milligrams 3 times daily, every day for 4 weeks along with standard first line treatment. A second group will be taken as control arm who will be kept on standard first line treatment only for 4 weeks. They will visit the hospital 2 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 2 and 4. Additionally, patient reported adverse events will be documented.",[57,27,58,59],"Dyspepsia","Epigastric Pain Syndrome","Epigastric Fullness",[57,61,62,63,64],"Post parendial distress syndrome (PPDS)","Epigastric pain syndrome (EPS)","Functional dyspepsia (FD)","Disorder of gut brain interaction (DGBI)","NOT_YET_RECRUITING","2026-05-05",{"date":68,"type":32},"2026-05-11",{"date":70,"type":21},"2026-05-15",{"date":72,"type":21},"2027-02-28",{"name":74,"class":39},"Rakibul Mostafa",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100627519","phase-4-comparing-acotiamide-and-itopride-for-the-management-of-indigestion-100627519","NCT07449689","Comparing Acotiamide and Itopride for the Management of Indigestion","A Double-Blind Superiority Randomized Controlled Trial Comparing Acotiamide vs Itopride for Functional Dyspepsia Management","Inclusion Criteria\n\n* Patients experiencing bothersome post-prandial fullness or bothersome early satiation at least three days a week.\n* Symptom onset must have occurred six months prior to diagnosis, and symptoms must have been present for at least the past three months.\n* No evidence of organic, systemic, or metabolic disease based on clinical investigations and endoscopy.\n* Patients with co-existing symptoms of Epigastric Pain Syndrome (EPS) are included only if the symptoms causing the most distress are meal-related.\n* Individuals who have already tested negative for H. pylori (separate tests will not be conducted for the study).\n\nExclusion Criteria\n\n* Patients with an identifiable organic disease that can explain their symptoms, such as peptic ulcer, GERD, or chronic pancreatitis.\n* Patients with a history of gastrointestinal surgery.\n* History of malignancy in the past five years.\n* Patients having major psychiatric or depressive disorders.\n* Patients with a history of drug or alcohol abuse.\n* Patients with advanced chronic kidney disease.\n* Patients with uncontrolled diabetes (HbA1c \\>8).\n* Patients with uncontrolled hypertension.\n* Patients diagnosed with Irritable Bowel Syndrome.\n* Pregnant or lactating women.\n* Patients who have used antibiotics, opioids, or any other medication that -affects gastrointestinal function in the past 4 weeks.\n* H. pylori positive patients.\n* Patients who cannot fill out scales or record their symptoms.",{"count":83,"type":21},368,[54],"This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning.\n\nThe primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms.\n\nParticipants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily.\n\nFollowing the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day.\n\nThe treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach.\n\nParticipants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.",[27,87],"Post Prandial Distress Syndrome",[89,90,91,92,93],"Functional Dyspepsia","Acotiamide","Itopride","Post-Prandial Distress Syndrome","Gastroprokinetic","2026-03-05",{"date":96,"type":32},"2026-03-06",{"date":98,"type":21},"2026-04",{"date":100,"type":21},"2027-05",{"name":102,"class":39},"Aga Khan University",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100587656","efficacy-of-gut-brain-neuromodulators-for-functional-dyspepsia-100587656","NCT06931223","Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia","Efficacy of Gut-rain Neuromodulators in the Treatment of Functional Dyspepsia: a Randomized Controlled Study","Inclusion Criteria:\n\n1. adult patients with primary FD who meet the diagnostic criteria for Roman IV;\n2. able to complete the questionnaire, trial evaluation and sign the written informed consent.\n\nExclusion Criteria:\n\n1. organic gastrointestinal diseases by gastroenteroscopy within 6 months;\n2. severe insufficiency of heart, liver, kidney, lung and other important organs and with congenital diseases;\n3. allergic to the drugs used in this study\n4. being pregnant, lactating or planning to become pregnant;\n5. are taking or have taken monoamine oxidase inhibitors within the past 5 weeks;\n6. have a known risk of narrow angle glaucoma.","80 Years",{"count":112,"type":21},200,[24],"The use of Neuromodulators is now recognized by international consensus as effective in improving Disorders of Gut-Brain Interaction (DGBIs). However, the digestive mind-body concept of therapeutic drugs is still in the experience-based treatment stage, and there is a lack of clinical studies in the field of DGBIs. Although numerous studies have been conducted to confirm the safety of Neuromodulators for the treatment of DGBIs, the current functional dyspepsia (FD) treatment is still awaiting further explorations and accumulations. In addition, neuromodulators, like Flupentixol-Melitracen (FM), are often used as a second-line treatment option for FD after the failure of acid-suppressive therapy with proton pump inhibitors, etc. However, the efficacy of conventional drugs for FD is mediocre, which often leads to recurrent and prolonged symptoms, seriously affecting patients' confidence in treatment and their quality of life, and the repeated visits to the clinic also create a huge economic burden for the society. Therefore, we conducted a clinical trial to verify whether FM can be used as the first-line therapy to improve the efficacy of FD patients.",[27],"2025-04-09",{"date":118,"type":32},"2025-04-17",{"date":120,"type":21},"2025-04-10",{"date":122,"type":21},"2025-09-10",{"name":124,"class":39},"RenJi Hospital"]