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

Osaka City University

Status and phase: Completed; Phase 4

Conditions: Functional Dyspepsia

Treatments: Drug: Rikkunshito placebo; Drug: Rikkunshito

Study type: Interventional

Funder types: Other

Identifiers

NCT02037776

Tj43-p2-t1

Details and patient eligibility

About

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

Enrollment: 128 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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
• Pregnant or lactating women or those who are planning to conceive during the study period
• Deemed ineligible by principal investigator or sub-investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Rikkunshito Placebo

Placebo Comparator group

Treatment:

Drug: Rikkunshito placebo

Rikkunshito

Active Comparator group

Treatment:

Drug: Rikkunshito