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The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia | Clinical Trials | Clareo Health

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

Double-blind Trial With Rikkunshito Versus Placebo on Efficacy and Safety in Patients With Functional Dyspepsia: Multi-center Study (DREAM Study)

NCT02037776•Osaka City University

View on ClinicalTrials.gov

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).

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•-Patients diagnosed with FD according to the ROME III criteria i) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to obtaining informed consent ii) Have not received upper endoscopy within the last 6 months prior to enrollment and do not have evidence of structural/organic disease iii) Must have one or more of the following symptoms:
•1. Bothersome postprandial fullness
•2. Early satiation
•3. Epigastric pain
•4. Epigastric burning
•At least one of the FD-related symptoms on the Global Overall Symptom (GOS) scale (bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning) is ≥4, whereas heartburn is ≤3.
•Total score of depression-related symptoms on Hospital Anxiety and Depression Score (HAD) is ≤10.
•Type of visit: Outpatient
•Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.

Exclusion Criteria

•Confirmed ulcer (excluding scars) or malignant tumor in the upper GI
•Suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis
•History of upper GI resection
•Serious complications (liver, kidney, heart, or blood disease or metabolic disease)
•Less than a year since testing positive for H. pylori or have undergone a successful eradication therapy
•Use of prohibited medications
•Neuropsychiatric disorders
•Use of or planned use of any investigational drugs
•Unable to take drugs orally
•History of allergic reactions to Kampo medicines
+2 more criteria

Locations (1)

Osaka City University Graduate School of Medicine

Abeno-ku, Osaka, Japan

Key Dates

Start Date

April 3, 2014

Primary Completion Date

March 25, 2016

Completion Date

March 25, 2016

Last Updated

July 27, 2017

Enrollment

128

ACTUAL participants

Conditions

Functional Dyspepsia

Interventions

Rikkunshito

DRUG

Rikkunshito placebo

DRUG

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

NCT07182890

Functional DyspepsiaProbiotics+2 more

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RECRUITING

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

NCT07196735

Functional DyspepsiaBIA+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

The Brain-Heart-Gut Connection

Enabling Microbiomics- Driven Personalized Nutrition

Cerebral Cortical Influences on Autonomic Function

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia