Status:
COMPLETED
Efficacy of Banhasasim-tang on Functional Dyspepsia
Lead Sponsor:
Korea Health Industry Development Institute
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 time...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00987805
Start Date
September 1 2009
End Date
January 1 2011
Last Update
June 21 2012
Active Locations (2)
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1
Kyung Hee University Medical Center Oriental Hospital
Seoul, South Korea, 130702
2
East-West Neo Medical Center
Seoul, South Korea, 134727