Efficacy of Banhasasim-tang on Functional Dyspepsia

Sponsor

Korea Health Industry Development Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00987805

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia	Dietary Supplement: Banhasasim-tang Dietary Supplement: Corn-starch granules	Phase 4

Detailed Description

Banhasasim-tang

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.
Usually having used for dyspepsia in asia
Need for correct clinical information by RCT

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Banhasasim-tang	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 Other Names: Brand names : Bansasin granules
Placebo Comparator: Placebo drug The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula	Dietary Supplement: 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. Other Names: Corn-starch granules with herb decoctions flavor

Arm

Intervention/Treatment

Experimental: Banhasasim-tang

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

Other Names:

Brand names : Bansasin granules

Placebo Comparator: Placebo drug

The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula

Dietary Supplement: 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.

Other Names:

Corn-starch granules with herb decoctions flavor

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 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:

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