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

NCT ID: NCT02037776

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-03
• Study Completion Date: 2016-03-25

Brief 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).

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rikkunshito Placebo

Group Type: PLACEBO_COMPARATOR

Rikkunshito placebo

Intervention Type: DRUG

\- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks

Rikkunshito

Group Type: ACTIVE_COMPARATOR

Rikkunshito

Intervention Type: DRUG

\- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks

Interventions

Rikkunshito

\- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks

Intervention Type: DRUG

Rikkunshito placebo

\- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Tsumura Rikkunshito

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osaka City University

OTHER

Sponsor Role: lead

Responsible Party

Kazunari Tominaga

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tetsuo Arakawa

Role: STUDY_DIRECTOR

Osaka City University Graduate School of Medicine

Locations

Osaka City University Graduate School of Medicine

Abeno-ku, Osaka, Japan

Countries

Japan

Other Identifiers

Tj43-p2-t1

Identifier Type: -

Identifier Source: org_study_id