NCT03856294

The Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance in Functional Dyspepsia

A Placebo-controlled Study on the Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance, Quantified by Intragastric Pressure Monitoring During Intragastric Nutrient Infusion, in Functional Dyspepsia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Functional dyspepsia (FD) is a common chronic gastrointestinal (GI) disorder. Rikkunshito, a traditional Japanese Kampo medicine, has shown efficacy in improving FD symptoms in controlled trials in Japan. Its putative benefit for European patients has never been investigated. Further, its exact mechanism of action is incompletely elucidated. This study aimed to examine the effect of rikkunshito on gastric motility and GI symptom perception in FD in a randomized, placebo-controlled, cross-over study. Intragastric pressure (IGP) was assessed using high-resolution manometry as an indirect measurement of gastric accommodation and gastric motility.

Detailed description

This randomized, placebo-controlled, double-blind, cross-over study had a total duration of 14 weeks, consisting of a two-week run-in period, two treatment phases of four weeks each and a four-week washout period separating the treatment phases to prevent carry-over effects. Study visits were held at baseline (screening) and after the run-in period, treatment phases and washout period. To assess the effect of rikkunshito on intragastric pressure as an indirect measure for gastric motility, high-resolution manometry (HRM) was performed after the run-in period and after both treatment phases. During intragastric pressure measurement, a nutrient tolerance test was performed and symptom questionnaires were completed. Throughout the entire study, patients scored their gastrointestinal symptoms on a daily basis in the Leuven Postprandial Distress Scale (LPDS) diary. In addition, questionnaires on gastrointestinal symptoms and psychosocial state were completed each study visit. Safety measures performed each study visit included blood pressure, heart rate and weight assessment, performing an electrocardiogram, adverse event evaluation and physical examination. Furthermore, blood samples were collected during screening and after each treatment phase to check liver and kidney function. Serum levels of potassium, creatine kinase, aspartate aminotransferase, alanine transaminase, alkaline phosphatase and gamma- glutamyltransferase were assessed. Women of childbearing potential were asked to do a pregnancy test before study enrollment and before each treatment period.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DRUG	Rikkunshito	Rikkunshito, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake
DRUG	Placebos	Placebo, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2019-02-27
• Last updated: 2019-03-01

Locations

1 site across 1 country: Belgium