drugset / Trial / NCT03856294
The Effect of Rikkunshito on Gastric Accommodation and Nutrient Volume Tolerance in Functional Dyspepsia
Phase 2
Completed
34 enrolled
Universitaire Ziekenhuizen KU Leuven
Tsumura and Company, Tokyo, Japan · collab
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2015-12
- Primary completion
- 2018-10
- Completion
- 2018-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rikkunshito | Traditional medicine (herbal / TCM) | 2.5 g | — |