Contact information
Type
Scientific
Primary contact
Prof Jae-Woo Park
ORCID ID
Contact details
149
East-West Neo Medical Centre
Kyung Hee University
Sangil-dong
Gangdong-gu
Seoul
134-727
Korea
South
+82 (0)2 440 6219
pjw2907@khu.ac.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00987805
Protocol/serial number
B090029
Study information
Scientific title
Efficacy of banhasasim-tang on functional dyspepsia: a randomised, double blind, placebo controlled, two-centre trial
Acronym
Study hypothesis
Banhasasim-tang could improve symptoms of dyspepsia in adult functional dyspepsia patients.
Ethics approval
1. Kyung Hee University Oriental Medical Centre approved on 30th April 2009
2. Oriental Medical Centre, East-West Neo Medical Centre, Kyung Hee University approved on 9th March 2009
Study design
Two-centre randomised double-blind two-arm placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Functional dyspepsia
Intervention
1. Patients in banhasasim-tang group receive a pack of this herbal formula (3 g), that is formed in granules, for three times a day after meal
2. Patients in placebo group receive a pack of corn-starch granules (3 g) that have the same color and taste as banhasasim-tang granules for three times a day after meal
The total duration of both arms is 14 weeks. Timepoints are as follows:
Visit 1: Screening
Visit 2: Randomisation and first administration of banhasasim-tang or placebo for 2 weeks
Visit 3: Follow-up and second administration for 2 weeks
Visit 4: Follow-up and third administration for 2 weeks
Visit 5: Treatment finish and follow-up
Visit 6: 4 weeks later of treatment finish and follow-up
Visit 7: 8 weeks later of treatment finish and follow-up
Intervention type
Drug
Phase
Not Specified
Drug names
Banhasasim-tang
Primary outcome measure
1. Gatrointestinal Symptom (GIS) score: This score comprises 10 dyspeptic symptoms (epigastric pain/upper abdominal pain, abdominal cramps, fullness, early satiety, loss of appetite, sickness, nausea, vomiting, retrosternal discomfort, and acidic regurgitation/heartburn)
2. Symptom severity is assessed by 5-point Likert Scale (0: none, 1: slight, 2: moderate, 3: severe, 4: very severe)
Assessment will be conducted at baseline, 2, 4, and 6 weeks after administration, 4 and 8 weeks after treatment finish.
Secondary outcome measures
1. Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia, assessed at baseline, 2, 4, and 6 weeks after administration, 4 and 8 weeks after treatment finish
2. Functional Dyspepsia-related Quality of Life (FD-QoL), assessed at baseline, 2, 4, and 6 weeks after administration, 4 and 8 weeks after treatment finish
3. Electrogastrography (EGG) will be conducted at baseline and 6 weeks after administration
Overall trial start date
15/09/2009
Overall trial end date
31/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Typical functional dyspepsia according to ROME III criteria
1.1. One or more of:
1.1.1. Bothersome post-prandial fullness
1.1.2. Early satiation
1.1.3. Epigastric pain
1.1.4. Epigastric burning
1.2. 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. Regardless of sex, age range between 18 and 75 year old
5. Written and informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. History of peptic ulcer or gastroesophageal reflux disese (GERD)
2. Current prominent symptoms of irritable bowel syndrome or GERD
3. Presence of the following alarm symptoms:
3.1. Severe weight loss
3.2. Black or tar stool
3.3. 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
Recruitment start date
15/09/2009
Recruitment end date
31/01/2011
Locations
Countries of recruitment
Korea, South
Trial participating centre
149, East-West Neo Medical Centre
Seoul
134-727
Korea, South
Sponsor information
Organisation
Korea Health Industry Development Institute (KHIDI) (South Korea)
Sponsor details
57-1 Noryangjin-dong Dongjak-gu
Seoul
158-800
Korea
South
+82 (0)2 2194 7468
cyhan@khidi.or.kr
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Korea Health Industry Development Institute (KHIDI) (South Korea) - The 2009 grant of the Traditional Korean Medicine R&D Project, Ministry for Health & Welfare & Family Affairs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20670451
Publication citations
-
Protocol
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, 11, 83, doi: 10.1186/1745-6215-11-83.