Efficacy of Banhasasim-tang on Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987805
• Other study ID #: B090029
• Secondary ID: ISRCTN51910678
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2009
• Last updated: June 20, 2012
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: Korea Health Industry Development Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Dietary Supplement:
• Banhasasim-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
• Corn-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.

Locations

Country	Name	City	State
Korea, Republic of	East-West Neo Medical Center	Seoul
Korea, Republic of	Kyung Hee University Medical Center Oriental Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia		Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish	No
Secondary	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	No
Secondary	Electrogastrography (EGG)		Baseline, 6 weeks after administration	No