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

Not Applicable

• Conditions: Functional Dyspepsia

• Registration Number: JPRN-UMIN000003954
• Lead Sponsor: Office of Rikkunshito study

Brief Summary

BACKGROUND: Rikkunshito, a standardized Japanese herbal medicine, is thought to accelerate gastric emptying and relieve dyspepsia, although no large-scale, randomized, placebo-controlled trials of rikkunshito have been conducted. This study aimed to determine the efficacy and safety of rikkunshito for treating functional dyspepsia (FD). METHODS: FD patients received 2.5 g rikkunshito or placebo three times a day for 8 weeks in this multicenter, randomized, placebo-controlled, parallel-group trial. The primary end point was the proportion of responders at 8 weeks after starting test drug, determined by global patient assessment (GPA). The improvement in four major dyspepsia symptoms severity scale was also evaluated. In addition, plasma ghrelin levels were investigated before and after treatment. KEY RESULTS: Two hundred forty-seven patients were randomly assigned. In the eighth week, the rikkunshito group had more GPA responders (33.6%) than the placebo (23.8%), although this did not reach statistical significance (p = 0.09). Epigastric pain was significantly improved (p = 0.04) and postprandial fullness tended to improve (p = 0.06) in the rikkunshito group at week 8. Rikkunshito was relatively more effective among Helicobacter pylori-infected participants (rikkunshito: 40.0% vs placebo: 20.5%, p = 0.07), and seemed less effective among H. pylori-uninfected participants (rikkunshito: 29.3% vs placebo: 25.6%, p = 0.72). Among H. pylori-positive individuals, acyl ghrelin levels were improved just in rikkunshito group. There were no severe adverse events in both groups. CONCLUSIONS & INFERENCES: Administration of rikkunshito for 8 weeks reduced dyspepsia, particularly symptoms of epigastric pain and postprandial fullness. (UMIN Clinical Trials Registry, Number UMIN000003954).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-27
• Study Completion: 2013-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 430

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