Functional Dyspepsia
Conditions
Keywords
Functional dyspepsia, Banhasasim-tang, Gastrointestinal Symptom score, Visual Analogue Scale, Functional Dyspepsia-related Quality of Life, Electrogastrography
Brief summary
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
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
Interventions
DIETARY_SUPPLEMENTBanhasasim-tang
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
DIETARY_SUPPLEMENTCorn-starch granules
This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.
Sponsors
Korea Health Industry Development Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
South Korea
Outcome results
None listed