Gastroesophageal reflux disease (GERD)
Conditions
Interventions
Oral administration of rikkunshito (7.5g) combined with standard-dose rabeprazole (10mg)
Oral administration of placebo (7.5g) combined with standard-dose rabeprazole (10mg)
Sponsors
G-PRIDE Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who were diagnosed with GERD on the Montreal Definition criteria, and had no esophageal mucosal erosion in endoscopy carried out within six months before the registration 2. Patients who had received the treatment with standard-doze PPI for 4 weeks or more 3. Patients who had 8 or more of FSSG score before the registration 4. Patients who are plan to receive the treatment with rabeprazole (10mg) for 8 weeks or more 5. Patients aged 20 or over 6. Patients who signed consent to participate with the enough understanding in this study after the explanation about the objective and details of this study
Exclusion criteria
Exclusion criteria: 1. Patients with esophageal mucosal erosion in endoscopy carried out within six months before the registration 2. Patients who had less than 8 of FSSG score before the registration 3. Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders etc.) 4. Patients who underwent surgery to remove the upper digestive tract 5. Patients in whom the presence of a peptic ulcer (excluding ulcer scar) or malignant tumor of the upper digestive tract was confirmed 6. Patients with inflammatory bowel disease, irritable bowel syndrome, esophagostenosis or esophageal achalasia 7. Patients who were given a diagnosis of gastrointestinal motility disorder by the study investigator 8. Patients in whom organic hepatic/biliary/pancreatic disorders such as gallstone, hepatitis, and pancreatitis, were suspected 9. Patients with hemorrhage of the digestive tract, mechanical ileus, or perforation of the digestive tract 10. Patients who received drugs prohibited for concomitant use during the observation period 11. Patients with psychoneurosis 12. Patients with planning or during treatment of investigational drug 13. Patients with pregnant, considering pregnancy or lactation 14. Patients who are intolerant to oral administration 15. Patients with a history of drug allergy for Kampo medicine 16. Other who were not considered to be eligible as subjects of this study by the chief or study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparison with the improvement of FSSG score 2. Comparison with the improvement of QOL(SF-8, GSRS) score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison with the disappearance rate of symptoms 2. The efficacy (FSSG, SF-8, GSRS) in each group 3. Subgroup analysis 4. Comparison with patient impression after each treatment | — |
Countries
Japan
Contacts
Public ContactKazunari Tominaga
G-PRIDE Study Support Center (Osaka City University Graduate Medical School) Department of Gastroenterology
Outcome results
None listed