Efficacy of Banhasasim-tang on Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin-sung Kim, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier:
NCT00987805
First received: September 30, 2009
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Functional Dyspepsia
Dietary Supplement: Banhasasim-tang
Dietary Supplement: Corn-starch granules
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial

Resource links provided by NLM:


Further study details as provided by Korea Health Industry Development Institute:

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) [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Electrogastrography (EGG) [ Time Frame: Baseline, 6 weeks after administration ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Corn-starch granules with herb decoctions flavor

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987805

Locations
Korea, Republic of
Kyung Hee University Medical Center Oriental Hospital
Seoul, Korea, Republic of, 130702
East-West Neo Medical Center
Seoul, Korea, Republic of, 134727
Sponsors and Collaborators
Korea Health Industry Development Institute
Investigators
Principal Investigator: Jin-sung Kim, Ph.D Kyung Hee University Medical Center Oriental Hospital
  More Information

No publications provided by Korea Health Industry Development Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin-sung Kim, Full professor, Korea Health Industry Development Institute
ClinicalTrials.gov Identifier: NCT00987805     History of Changes
Other Study ID Numbers: B090029, ISRCTN51910678
Study First Received: September 30, 2009
Last Updated: June 20, 2012
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Korea Health Industry Development Institute:
Functional dyspepsia
Banhasasim-tang
Gastrointestinal Symptom score
Visual Analogue Scale
Functional Dyspepsia-related Quality of Life
Electrogastrography

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on October 19, 2014