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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN51910678 | Other Grant/Funding Number | ISRCTN51910678 |
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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.
Banhasasim-tang
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Banhasasim-tang | Experimental |
| |
| Placebo drug | Placebo Comparator | The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Banhasasim-tang | Dietary 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Typical functional dyspepsia according to ROME III criteria.
One or more of:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jin-sung Kim, Ph.D | Kyung Hee University Medical Center Oriental Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Medical Center Oriental Hospital | Seoul | 130702 | South Korea | |||
| East-West Neo Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20670451 | Derived | Park JW, Ryu B, Yeo I, Jerng UM, Han G, Oh S, Lee J, Kim J. Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial. Trials. 2010 Jul 30;11:83. doi: 10.1186/1745-6215-11-83. |
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| Corn-starch granules | Dietary Supplement | This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention. |
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| Electrogastrography (EGG) | Baseline, 6 weeks after administration |
| Seoul |
| 134727 |
| South Korea |