Efficacy of Banhasasim-tang on Functional Dyspepsia - Full Text View

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:

MedlinePlus related topics: Indigestion Nausea and Vomiting

U.S. FDA Resources

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

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

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

Eligibility

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

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

Contacts and Locations

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):

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.

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 May 21, 2013