Condition category
Digestive System
Date applied
04/09/2009
Date assigned
18/09/2009
Last edited
11/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://eng.khidi.or.kr/

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

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20670451

Publication citations

  1. 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.

Additional files

Editorial Notes