Gastroesophageal reflux disease (GERD)
Conditions
Interventions
experimental group:On the basis of proton pump inhibitor (rabeprazole 20mg, orally, 1 day), agomelatine 25mg/d was added, orally before bedtime
control group:On the basis of proton pump inhibitor (rabeprazole 20mg, orally, 1/ day) treatment, soothing agents were added, orally before bedtime
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years, no gender limitation: 2.Meeting any of the following diagnostic criteria for GERD: (1) GERDQ score >= 8; (2) Erosion esophagitis (EE) was diagnosed through endoscopic examination; (3) 24h pH of esophagus was positive; 3.Willingness to participate in the study and are able to sign or have their legal representative to sign the informed consent.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria: 1.History of gastrointestinal surgery, gastrointestinal tumor, peptic ulcer, Barret esophagus, eosinophilic esophagitis; 2.Patients with esophageal motility disorders such as achalasia of cardia and diffuse esophageal spasm; 3.Recent warning symptoms such as digestive tract bleeding; 4.Diagnosed infection with Helicobacter pylori; 5.Administration history of non-steroidal anti-inflammatory drugs (NSAIDs) in the past one month; 6.Severe heart and lung diseases, diabetes, rheumatic immune system diseases; 7.Severe mental illness or suicide attempt; 8.Recent administration of antipsychotic and sedative adjuvant medications, including benzodiazepines, tricyclic acids (TCA), selective serotonin reuptake inhibitors (SSRIs), selective serotonin and norepinephrine reuptake inhibitors (SNRIs), etc.; 9.Patients with positive hepatitis B virus (HBV) surface antigen, positive hepatitis C virus (HCV) antibody or serum aminotransferase (ALT) elevation >= 3 times the upper limit of normal value; 10.Allergic to rabeprazole, agomelatine or their excipients; 11.Patients currently taking fluvoxamine, estrogen, and rifampicin; 12.Pregnant or lactating women, or women of childbearing age who take no contraceptive measures; 13.Currently participating in clinical trials of other drugs or medical devices; 14.The researchers did not consider it suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of patients with GERDQ scores decreased by >=50% in both groups at the end of 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of patients with GERDQ scores decreased by >=50% in both groups at the end of 8 weeks;The healing rate of lower esophageal mucosa in erosive esophagitis at the end of 8 weeks; | — |
Countries
China
Contacts
Public ContactZou Duowu
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed