Prospective, randomized controlled trial for effect of rikkunshito on symptoms in PPI-refractory gastroesophageal reflux disease (GERD) patients

Not Applicable

• Conditions: Gastroesophageal reflux disease (GERD)

• Registration Number: JPRN-UMIN000005880
• Lead Sponsor: G-PRIDE Study Group

Brief Summary

Rikkunshito may be useful for improving mental QOL in non-obese patients with PPI-refractory NERD and acid-related dyspeptic symptoms, especially women and the elderly

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-28
• Study Completion: 2012-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified