[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602895":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":26,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"Xijing Hospital of Digestive Diseases","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The Berberine group","EXPERIMENTAL","Patients in the Berberine group will receive oral Berberine hydrochloride at a dosage of 300 mg two times daily for 6 months",[13],"Drug: Berberine hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"The placebo group","PLACEBO_COMPARATOR","Patients in the placebo group will receive oral placebo at a dosage of 300 mg two times daily for 6 months",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Berberine hydrochloride","Subjects will be instructed to take three tablets (300mg) of Berberine hydrochloride two times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Subjects will be instructed to take three tablets (300mg) of placebo two times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yongquan Shi Shi","CONTACT","029-84771515","shiyquan@fmmu.edu.cn",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Yongquan Shi","Professor","100602895","phase-4-efficacy-and-safety-of-berberine-for-gastric-intestinal-metaplasia-100602895",false,"NCT07129460","Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia","Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n* patients aged from 18 to 75 years old.\n* patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.\n* patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.\n\nExclusion Criteria:\n\n* a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and\u002For statins\u002For Metformin.\n* a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.\n* a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study.\n* breastfeeding or pregnancy.\n* a history of substance abuse or alcohol abuse within the past one year.\n* patients with severe mental illness.\n* refusal to undergo drug treatment.\n* refusal to sign informed consent.","ALL","18 Years","75 Years",{"count":52,"type":53},204,"ESTIMATED","INTERVENTIONAL",[56],"PHASE4","The goal of this clinical trial is to investigate the efficacy of Berberine in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of Berberine. The main questions it aims to answer are:\n\nDoes Berberine promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Berberine? Researchers will compare Berberine to a placebo (a look-alike substance that contains no drug) to see if uBerberine is effective in treating gastric intestinal metaplasia.\n\nParticipants will:\n\nTakeBerberine or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.",[59],"Gastric Intestinal Metaplasia","NOT_YET_RECRUITING","2025-08-26",{"date":63,"type":64},"2025-09-04","ACTUAL",{"date":66,"type":53},"2025-10-01",{"date":68,"type":53},"2027-05-01",{"name":5,"class":6}]