Efficacy of banhasasim-tang on functional dyspepsia

Not Applicable

Completed

• Conditions: Functional dyspepsia; Digestive System; Dyspepsia

• Registration Number: ISRCTN51910678
• Lead Sponsor: Korea Health Industry Development Institute (KHIDI) (South Korea)

Brief Summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20670451 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23861702 [added 06/03/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-18
• Study Completion: 2011-01-31
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Typical functional dyspepsia according to ROME III criteria
1.1. One or more of:
1.1.1. Bothersome post-prandial fullness
1.1.2. Early satiation
1.1.3. Epigastric pain
1.1.4. Epigastric burning
1.2. 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. Regardless of sex, age range between 18 and 75 year old
5. Written and informed consent

Exclusion Criteria

1. History of peptic ulcer or gastroesophageal reflux disese (GERD)
2. Current prominent symptoms of irritable bowel syndrome or GERD
3. Presence of the following alarm symptoms:
3.1. Severe weight loss
3.2. Black or tar stool
3.3. 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: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Gastrointestinal Symptom (GIS) score: This score comprises 10 dyspeptic symptoms (epigastric pain/upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrosternal discomfort, and acidic regurgitation/heartburn)<br> 2. Symptom severity is assessed by 5-point Likert Scale (0: none, 1: slight, 2: moderate, 3: severe, 4: very severe)<br><br> Assessment will be conducted at baseline, 2, 4, and 6 weeks after administration, 4 and 8 weeks after treatment finish.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia, assessed at baseline, 2, 4, and 6 weeks after administration, 4 and 8 weeks after treatment finish<br> 2. Functional Dyspepsia-related Quality of Life (FD-QoL), assessed at baseline, 2, 4, and 6 weeks after administration, 4 and 8 weeks after treatment finish<br> 3. Electrogastrography (EGG) will be conducted at baseline and 6 weeks after administration<br>