Clinical trial NCT00987805: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Dyspepsia
Keywords: Functional dyspepsia
Banhasasim-tang
Gastrointestinal Symptom score
Visual Analogue Scale
Functional Dyspepsia-related Quality of Life
Electrogastrography
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2009-10-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: 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)
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish
Secondary outcomes:
measure: Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia
timeFrame: Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish
measure: Functional Dyspepsia-related Quality of Life (FD-QoL)
timeFrame: Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish
measure: Electrogastrography (EGG)
timeFrame: Baseline, 6 weeks after administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center Oriental Hospital
city: Seoul
country: Korea, Republic of
facility: East-West Neo Medical Center
Study officials:
affiliation: Kyung Hee University Medical Center Oriental Hospital
name: Jin-sung Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.