[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658850":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":38,"interventions":52,"overallOfficials":31,"centralContacts":67,"locations":74,"responsibleParty":89,"collaborators":31,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":31,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":31,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":77,"whyStopped":31,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Buddhist Tzu Chi General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":31},[9,13,16,19,22,25,28],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline on the Functional Dyspepsia Scale(FD) at 84 days","Possible scores range from 0 (Very slightly) to 6 (Very serious) 0=Very slightly 1=Slight 2=A little slightly 3=About medium 4=A bit serious 5=Severe 6=Very serious Change = (day 84 Score - Baseline Score).","Baseline and day 84",{"measure":14,"description":15,"timeFrame":12},"Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 84 days","Possible scores range from 1 (No pain) to 7 (very serious)\n\n1=No pain 2=Very minor 3=Mild 4=Moderate 5=Moderate to severe 6= severe 7=very serious Change = (day 84 Score - Baseline Score).",{"measure":17,"description":18,"timeFrame":12},"Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 84 days","Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 84 Score - Baseline Score).",{"measure":20,"description":21,"timeFrame":12},"Change from Baseline on the Taiwanese Depression Scale (TDQ) at 84 days","Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 84 Score - Baseline Score).",{"measure":23,"description":24,"timeFrame":12},"Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 84 days","Possible scores range from 1 (Never) to 4 (Always)\n\n1=Never 2=Sometimes 3=Often 4=Always Change = (day 84 Score - Baseline Score).",{"measure":26,"description":27,"timeFrame":12},"Change from Baseline on the Perceived Stress Scale(PSS-10) at 84 days","Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 84 Score - Baseline Score).",{"measure":29,"description":30,"timeFrame":12},"Change from Baseline on the Visceral Sensitivity Index (VSI) at 84 days","Possible scores range from 0 (Strongly disagree) to 5 (Strongly agree) 0=Strongly agree 1=Moderately agree 2=Mildly agree 3=Mildly disagree 4 =Moderately disagree 5=Strongly disagree Change = (day 84 Score - Baseline Score).",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE",[39,43,46],{"label":40,"type":41,"description":42,"interventionNames":31},"H1\u002FH2 combination antagonist group","EXPERIMENTAL","Famotidine 20mg\u002Ftab This product is used for the treatment of peptic ulcers and gastroesophageal reflux disease (GERD). It competitively inhibits histamine at the H2 receptors on gastric parietal cells, thereby reducing gastric acid secretion (Ministry of Health and Welfare Drug License No. 041352).\n\nLevocetirizine 5mg\u002Ftab This is an antihistamine used to relieve various symptoms of allergies. Levocetirizine is an antihistamine that selectively competes with histamine at the H1 receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory system (Ministry of Health and Welfare Drug License No. 023792).",{"label":44,"type":41,"description":45,"interventionNames":31},"H1 antagonist only group","Levocetirizine 5mg\u002Ftab This is an antihistamine used to relieve various symptoms of allergies. Levocetirizine is an antihistamine that selectively competes with histamine at the H1 receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory system (Ministry of Health and Welfare Drug License No. 023792).\n\n\"Fuyuan\" Gasmin Tablets 40mg\u002Ftab This product appears as a round, white tablet. It works in the gastrointestinal tract by reducing the surface tension of gas bubbles, causing the bubbles attached to the gastrointestinal mucosa to rupture due to the change in tension. This facilitates the expulsion of gas from the body through belching or flatulence. (Taiwan FDA Drug License No. 000415).",{"label":47,"type":48,"description":49,"interventionNames":50},"Control group","PLACEBO_COMPARATOR","\"Fuyuan\" Gasmin Tablets 40mg\u002Ftab This product appears as a round, white tablet. It works in the gastrointestinal tract by reducing the surface tension of gas bubbles, causing the bubbles attached to the gastrointestinal mucosa to rupture due to the change in tension. This facilitates the expulsion of gas from the body through belching or flatulence. (Taiwan FDA Drug License No. 000415).",[51],"Drug: Fuyuan Gasmin",[53,57,60,64],{"type":54,"name":55,"description":56,"armGroupLabels":31,"otherNames":31},"DRUG","Famotidine","20mg twice daily",{"type":54,"name":58,"description":59,"armGroupLabels":31,"otherNames":31},"Levocetirizine","5mg once before bed",{"type":54,"name":61,"description":62,"armGroupLabels":63,"otherNames":31},"Fuyuan Gasmin","40mg\u002Ftab once before bed",[47],{"type":54,"name":61,"description":65,"armGroupLabels":66,"otherNames":31},"40mg\u002Ftab twice daily",[47],[68],{"name":69,"role":70,"phone":71,"phoneExt":72,"email":73},"Ming-Wun Wong","CONTACT","+886 8561825","13224","hypertr42@gmail.com",[75],{"facility":76,"status":77,"city":78,"state":31,"zip":31,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Hualien Tzu Chi Hospital","RECRUITING","Hualien City","Taiwan","TW",{"type":82,"coordinates":83},"Point",[84,85],121.60444,23.97694,{"lat":85,"lon":84},[88],{"name":69,"role":70,"phone":71,"phoneExt":72,"email":73},{"type":90,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100658850","phase-2-exploring-novel-therapeutic-approaches-for-disorders-of-gut-liver-brain-interaction-h1h2-100658850",false,"NCT07857941","Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1\u002FH2","Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction: Impact on Gastrointestinal and Psychological Symptoms as Well as Pathophysiological Alterations","Inclusion Criteria:\n\n* Aged between 18-64 years, mentally alert, and willing to sign the informed consent form.\n* Meeting the definition of functional dyspepsia: Functional dyspepsia is characterized by chronic upper gastrointestinal symptoms (at least once a week, persisting for at least three months, with symptom onset at least six months prior), including any of the following: postprandial bloating, early satiety, epigastric pain, or epigastric burning, with no abnormalities detected on upper gastrointestinal endoscopy.\n\nExclusion Criteria:\n\n* Have undergone upper gastrointestinal surgery in the past two months.\n* Are currently using antibiotics for an infectious disease.\n* Pregnant or breastfeeding women.\n* Have myocardial ischemia or have recently experienced a myocardial infarction.\n* Unable to cooperate.","ALL","18 Years","64 Years",{"count":102,"type":103},45,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","Functional dyspepsia (FD) is associated with inflammatory responses caused by the release of histamine from eosinophils and mast cells, leading to increased intestinal mucosal permeability, which is a key pathogenic mechanism.\n\nMeta-analyses have shown that H2 antihistamine drugs are as effective as proton pump inhibitors in treating FD, while H1 antihistamines achieve an efficacy rate of up to 79%. However, there is no research comparing the effects and pathological changes of combined H1\u002FH2 antagonists versus single H1 antagonists in the treatment of functional dyspepsia.\n\nRecent studies have shown that fatty liver disease and irritable bowel syndrome (IBS) share common comorbid factors, including obesity, gut microbiota, dietary factors, and immune-mediated causes. This has raised interest in whether these two conditions co-exist in patient populations. Moreover, the prevalence of IBS is higher in patients with fatty liver disease compared to global prevalence rates. A recent study found that up to 55.6% of patients with fatty liver have IBS, and it further suggests that patients with both IBS and fatty liver experience a lower quality of life and more severe physical and psychological symptoms.",[109],"Functional Gastrointestinal Disorders",[111,112,113,114],"antihistamine","Gut-brain axis dysregulation","gut-liver-brain axis","dyspepsia","2026-09-29",{"date":117,"type":118},"2026-10-05","ACTUAL",{"date":120,"type":118},"2025-01-01",{"date":122,"type":103},"2026-12-31",{"name":5,"class":6},1]