Efficacy of Banhasasim-tang on Functional Dyspepsia

Korea Health Industry Development Institute84 enrolled

Overview

The purpose of this study is to assess efficacy based on Gastrointestinal Symptom score and safety based on the rate of adverse event or laboratory findings of Banhasasim-tang administrated three times a day orally on functional dyspepsia.

Banhasasim-tang 1. Main 3 gram herb powder (including Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma) of old oriental prescriptions for dyspepsia. 2. Usually having used for dyspepsia in asia 3. Need for correct clinical information by RCT

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Functional Dyspepsia

Interventions

Banhasasim-tangDIETARY_SUPPLEMENT

Form : granules Contents : It consists of seven Herbs. It contains Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma Dosage and frequency : 9g per day (three times a day) Route of administration : Oral Administration duration : 42 days in the study

Corn-starch granulesDIETARY_SUPPLEMENT

This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Typical functional dyspepsia according to ROME III criteria. * One or more of: * Bothersome post-prandial fullness * Early satiation * Epigastric pain * Epigastric burning * No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms 2. The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms 3. Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks 4. Written and informed consent Exclusion Criteria: 1. History of peptic ulcer or gastroesophageal reflux disease(GERD) 2. Current prominent symptoms of irritable bowel syndrome or GERD 3. Presence of the following alarm symptoms: * Severe weight loss * Black or tar stool * Dysphagia 4. Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders 5. Women in pregnancy and lactation 6. History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system 7. Participation of other clinical trials within the last 3 months 8. Severe mental problems or drug abuse 9. Judged by expert that they are appropriate to participate in this study

Locations (2)

Kyung Hee University Medical Center Oriental Hospital

Seoul, South Korea

East-West Neo Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Gastrointestinal Symptom (GIS) score (epigastric pain/upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrosternal discomfort, and acidic regurgitation/heartburn)

Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish

Secondary Outcomes

Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia

Time frame: Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish

Functional Dyspepsia-related Quality of Life (FD-QoL)

Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish

Electrogastrography (EGG)

Time frame: Baseline, 6 weeks after administration

Data from ClinicalTrials.gov

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