Efficacy of Banhasasim-tang on Functional Dyspepsia

June 20, 2012 updated by: Jin-sung Kim, Korea Health Industry Development Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 130702
        • Kyung Hee University Medical Center Oriental Hospital
      • Seoul, Korea, Republic of, 134727
        • East-west neo medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish
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
Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish
Electrogastrography (EGG)
Time Frame: Baseline, 6 weeks after administration
Baseline, 6 weeks after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Health Industry Development Institute

Investigators

  • Principal Investigator: Jin-sung Kim, Ph.D, Kyung Hee University Medical Center Oriental Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B090029
  • ISRCTN51910678 (Other Grant/Funding Number: ISRCTN51910678)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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