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

NCT03856294 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-03-01

No results posted yet for this study

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.

Conditions

  • Dyspepsia

Interventions

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

Sponsors & Collaborators

  • Tsumura and Company, Tokyo, Japan

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, MD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03856294 on ClinicalTrials.gov