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

• Status: Completed
• Trial end date: 2016-03-25
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Osaka City University

Criteria

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

• Pregnant or lactating women or those who are planning to conceive during the study period

• Deemed ineligible by principal investigator or sub-investigator