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The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia

NCT02037776 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-07-27

Study results available
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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).

Conditions

  • Functional Dyspepsia

Interventions

DRUG

Rikkunshito

\- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks

DRUG

Rikkunshito placebo

\- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks

Sponsors & Collaborators

  • Osaka City University

    lead OTHER

Principal Investigators

  • Tetsuo Arakawa · Osaka City University Graduate School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-03
Primary Completion
2016-03-25
Completion
2016-03-25

Countries

  • Japan

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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 NCT02037776 on ClinicalTrials.gov