Functional Dyspepsia | The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
Functional Dyspepsia research study
What is the primary objective of this study?
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: April 3, 2014
Completed Date: March 25, 2016
Phase: Phase 4
Primary Outcome: Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
Secondary Outcome: Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)
Study sponsors, principal investigator, and references
Principal Investigator: Tetsuo Arakawa
Lead Sponsor: Osaka City University