[{"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":26,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":26,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":26,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"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",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":51,"type":52},204,"ESTIMATED","INTERVENTIONAL",[55],"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.",[58],"Gastric Intestinal Metaplasia","NOT_YET_RECRUITING","2025-08-26",{"date":62,"type":63},"2025-09-04","ACTUAL",{"date":65,"type":52},"2025-10-01",{"date":67,"type":52},"2027-05-01",{"name":5,"class":6}]