GERD
Conditions
Interventions
Hangeshashinto(7.5 g/t.i.d) and Rabeprazole (10 mg/day) for 4 weeks
Rabeprazole (20 mg/day) for 4 weeks
Sponsors
Osaka Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who were diagnosed with GERD(There is a possibility of reflux esophagitis) 2) Patients with heartburn or burp 3) Patients who had received the treatment with PPI for 4 weeks or more 4) Patients who had 8 or more of FSSG score before the registration 5) No criteria on sex. 6) Type of visit:Outpatient 7) Age: Aged 20 and over 8) Patients for whom oral administration was possible 9) Patients who provided written informed consent regarding study participation.
Exclusion criteria
Exclusion criteria: 1) History of upper GI resection 2) Confirmed presence of ulcer (excluding scars) or malignant tumor in the upper GI. 3) Non-erosive reflux disease (Los Angeles classification, Grade N) 4) suspected organic hepatic/biliary/pancreatic disorders such as gallstone, hepatitis, and pancreatitis 5) History of allergic reactions to Kampo medicines 6)Patients who is taking P-CAB. 7) Patients who were administered KAMPO medicine 4 weeks before entry. 8) receiving or scheduled to receive an agent that is being developed 9) presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease). 10) Pregnant or lactating women or those who are planning to conceive during the study period. 11) considered ineligible to participate by principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)reflux symptom(RS), acid-related dysmotility symptoms(ARD) and total score of frequency scale for the symptoms of GERD (FSSG) (afer treatment 4 weeks) 2)each score of FSSG (12items) (after treatment 4 weeeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)GI-related QOL: 5 subscale (abdominal pain,reflux syndrome,diarrhea syndrome, indigestion syndrome and constipation syndrome)and total scores of the Gastrointestinal Symptom Rating Scale(GSRS) 2)the improvement rate: the rate of GERD patients with total FSSG score<8 after treatment 3)Subgroup analysis by the subject's background factor (age,gender,BMI,etc.) | — |
Countries
Japan
Contacts
Public ContactToshihisa Takeuchi
Osaka Medical College 2nd Department of Internal Medicine
Outcome results
None listed