Efficacy of Banhasasim-tang on Functional Dyspepsia

Study Overview
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Brief Summary
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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.

Detailed Description
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Banhasasim-tang 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. Usually having used for dyspepsia in asia Need for correct clinical information by RCT

Official Title
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Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Banhasasim-tang
* Dietary Supplement: Corn-starch granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks Written and informed consent Exclusion Criteria: History of peptic ulcer or gastroesophageal reflux disease(GERD) Current prominent symptoms of irritable bowel syndrome or GERD Presence of the following alarm symptoms: Severe weight loss Black or tar stool Dysphagia Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders Women in pregnancy and lactation History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system Participation of other clinical trials within the last 3 months Severe mental problems or drug abuse Judged by expert that they are appropriate to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Banhasasim-tang<br> | Dietary Supplement: Banhasasim-tang<br>* 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<br>* Other names: Brand names : Bansasin granules;|
| Placebo Comparator: Placebo drug<br>The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula | Dietary Supplement: Corn-starch granules<br>* This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.<br>* Other names: Corn-starch granules with herb decoctions flavor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia |  | Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish | 
| Functional Dyspepsia-related Quality of Life (FD-QoL) |  | Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish | 
| Electrogastrography (EGG) |  | Baseline, 6 weeks after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional dyspepsia, Banhasasim-tang, Gastrointestinal Symptom score, Visual Analogue Scale, Functional Dyspepsia-related Quality of Life, Electrogastrography