Efficacy of Banhasasim-tang on Functional Dyspepsia

Phase 4

Completed

• Conditions: Functional Dyspepsia
• Interventions: Dietary Supplement: Banhasasim-tang; Dietary Supplement: Corn-starch granules

• Registration Number: NCT00987805
• Lead Sponsor: Korea Health Industry Development Institute

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

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-20
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Banhasasim-tang	Banhasasim-tang	-
Placebo drug	Corn-starch granules	The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Kyung Hee University Medical Center Oriental Hospital; 🇰🇷 Seoul, Korea, Republic of

East-West Neo Medical Center; 🇰🇷 Seoul, Korea, Republic of