The Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance in Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Rikkunshito; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Rikkunshito, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake; Placebo, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake
Other intervention name(s): TJ-43
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gastric motility; functional dyspepsia; functional dyspepsia symptoms