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Efficacy of Banhasasim-tang on Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Banhasasim-tang
Corn-starch granules
Sponsored by
Korea Health Industry Development Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional dyspepsia, Banhasasim-tang, Gastrointestinal Symptom score, Visual Analogue Scale, Functional Dyspepsia-related Quality of Life, Electrogastrography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyung Hee University Medical Center Oriental Hospital
  • East-West Neo Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Banhasasim-tang

Placebo drug

Arm Description

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

Outcomes

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)

Secondary Outcome Measures

Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia
Functional Dyspepsia-related Quality of Life (FD-QoL)
Electrogastrography (EGG)

Full Information

First Posted
September 30, 2009
Last Updated
June 20, 2012
Sponsor
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00987805
Brief Title
Efficacy of Banhasasim-tang on Functional Dyspepsia
Official Title
Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea Health Industry Development Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Functional dyspepsia, Banhasasim-tang, Gastrointestinal Symptom score, Visual Analogue Scale, Functional Dyspepsia-related Quality of Life, Electrogastrography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Banhasasim-tang
Arm Type
Experimental
Arm Title
Placebo drug
Arm Type
Placebo Comparator
Arm Description
The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula
Intervention Type
Dietary Supplement
Intervention Name(s)
Banhasasim-tang
Other Intervention Name(s)
Brand names : Bansasin granules
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn-starch granules
Other Intervention Name(s)
Corn-starch granules with herb decoctions flavor
Intervention Description
This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.
Primary Outcome Measure Information:
Title
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)
Time Frame
Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia
Time Frame
Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish
Title
Functional Dyspepsia-related Quality of Life (FD-QoL)
Time Frame
Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish
Title
Electrogastrography (EGG)
Time Frame
Baseline, 6 weeks after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-sung Kim, Ph.D
Organizational Affiliation
Kyung Hee University Medical Center Oriental Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Medical Center Oriental Hospital
City
Seoul
ZIP/Postal Code
130702
Country
Korea, Republic of
Facility Name
East-West Neo Medical Center
City
Seoul
ZIP/Postal Code
134727
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20670451
Citation
Park JW, Ryu B, Yeo I, Jerng UM, Han G, Oh S, Lee J, Kim J. Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial. Trials. 2010 Jul 30;11:83. doi: 10.1186/1745-6215-11-83.
Results Reference
derived

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Efficacy of Banhasasim-tang on Functional Dyspepsia

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