The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to
 placebo in Japanese subjects with Functional Dyspepsia (FD).
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