At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 128 enrolled
Drug / intervention
Rikkunshito +1 moredrug
Likely dose
Rikkunshito 2.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-blind Trial With Rikkunshito Versus Placebo on Efficacy and Safety in Patients With Functional Dyspepsia: Multi-center Study (DREAM Study)
In Brief
A Phase 4 clinical trial evaluating Rikkunshito and Rikkunshito placebo for Functional Dyspepsia. Completed, enrolled 128 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFunctional Dyspepsia
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartApr 2014
Primary CompletionMar 2016
TodayJul 2026
First PostedJan 16, 2014
Enrollment StartApr 3, 2014
Primary CompletionMar 25, 2016
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.5 years ago
Interventions
Rikkunshitodrug
\- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
Rikkunshito placebodrug
\- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks