Efficacy of banhasasim-tang on functional dyspepsia
| ISRCTN | ISRCTN51910678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51910678 |
| ClinicalTrials.gov number | NCT00987805 |
| Secondary identifying numbers | B090029 |
- 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
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 |
|---|---|
| pjw2907@khu.ac.kr |
Study information
| Study design | Two-centre randomised double-blind two-arm placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Banhasasim-tang |
| Primary outcome measure | 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. |
| 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 study start date | 15/09/2009 |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 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
134-727
Korea, South
Sponsor information
Korea Health Industry Development Institute (KHIDI) (South Korea)
Government
Government
57-1 Noryangjin-dong Dongjak-gu
Seoul
158-800
Korea, South
| Phone | +82 (0)2 2194 7468 |
|---|---|
| cyhan@khidi.or.kr | |
| Website | http://eng.khidi.or.kr/ |
"ROR" |
https://ror.org/00fdzyk40 |
Funders
Funder type
Government
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
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/07/2010 | Yes | No | |
| Results article | results | 01/07/2013 | 06/03/2019 | Yes | No |
Editorial Notes
06/03/2019: Publication reference added.
