Efficacy of banhasasim-tang on functional dyspepsia

ISRCTN	ISRCTN51910678
DOI	https://doi.org/10.1186/ISRCTN51910678
ClinicalTrials.gov (NCT)	NCT00987805
Protocol serial number	B090029
Sponsor	Korea Health Industry Development Institute (KHIDI) (South Korea)
Funder	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

Submission date: 04/09/2009
Registration date: 18/09/2009
Last edited: 06/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jae-Woo Park
Scientific

149, East-West Neo Medical Centre
Kyung Hee University
Sangil-dong, Gangdong-gu
Seoul
134-727
Korea, South

Phone	+82 (0)2 440 6219
Email	pjw2907@khu.ac.kr

Study information

Primary study design	Interventional
Study design	Two-centre randomised double-blind two-arm placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy of banhasasim-tang on functional dyspepsia: a randomised, double blind, placebo controlled, two-centre trial
Study objectives	Banhasasim-tang could improve symptoms of dyspepsia in adult functional dyspepsia patients.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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 Applicable
Drug / device / biological / vaccine name(s)	Banhasasim-tang
Primary outcome measure(s)	1. Gastrointestinal 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.
Key secondary outcome measure(s)	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
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	15/09/2009
Date of final enrolment	31/01/2011

Locations

Countries of recruitment

Korea, South

Study participating centre

149, East-West Neo Medical Centre

Seoul
134-727
Korea, South

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013	06/03/2019	Yes	No
Protocol article	protocol	30/07/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/03/2019: Publication reference added.