Double-blind, randomized, placebo-controlled trial to examine the efficacy and the safety of Rikkunshito for PPI resistant Functional Dyspepsia

Not Applicable

• Conditions: Functional Dyspepsia

• Registration Number: JPRN-UMIN000006881
• Lead Sponsor: Office of Rikkunshito Study

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-26
• Study Completion: 2012-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patient with Organic disease such as reflux esophagitis (> grade A) and erosive gastritis. 2. Patients with past history of upper gastrointestinal surgery 3. Patients with past history of gastrectomy 4.Patients with an obvious cause of symptom 5. NSAIDs or low-dose aspirin -related dyspepsia 6. Patients with organic disease in the brain or with psychological disorders 7. Patients with alcoholics or with drug dependence 8. Severe endocrine disease including hyperthyroidism 9. Severe diseases in heart, liver and kidney. Severe infectious or hemotological diseases 10. Drug allegy for Rikkunshito 11.Expectant mother, mother with breast-feeding, or females who wish to become pregnant 12.Patient with H.pylori eradication within 6 months 13.Patients who take gastric secretion inhibitor, prokinetic agent, gastric antacid, anticholineric drug, cholinergic agent, tranquilizer, anxiolytic agent drug, antidepressive drug within 1 week 14. Patients with suspected IBS 15. other not applicable person recognized by a doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified