Functional DyspepsiaPhase 4NCT00987805
Efficacy of Banhasasim-tang on Functional Dyspepsia
A Phase 4 study testing Banhasasim-tang and Corn-starch granules in people with Functional Dyspepsia, run by Korea Health Industry Development Institute at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Banhasasim-tang and Corn-starch granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2009to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Typical functional dyspepsia according to ROME III criteria.
- One or more of:
- Bothersome post-prandial fullness
- Early satiation
- Epigastric pain
- Epigastric burning
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- No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
- The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms
- Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks
- Written and informed consent
Who cannot join
- History of peptic ulcer or gastroesophageal reflux disease(GERD)
- Current prominent symptoms of irritable bowel syndrome or GERD
- Presence of the following alarm symptoms:
- Severe weight loss
- Black or tar stool
- Dysphagia
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- Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders
- Women in pregnancy and lactation
- History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system
- Participation of other clinical trials within the last 3 months
- Severe mental problems or drug abuse
- Judged by expert that they are appropriate to participate in this study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Kyung Hee University Medical Center Oriental Hospital
Seoul, 130702
East-West Neo Medical Center
Seoul, 134727
About this study
Official title: Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial
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.
Read the detailed description
Banhasasim-tang
- 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.
- Usually having used for dyspepsia in asia
- Need for correct clinical information by RCT
- Conditions
- Functional Dyspepsia
- Being tested
- Banhasasim-tang, Corn-starch granules
- Keywords
- Functional dyspepsia, Banhasasim-tang, Gastrointestinal Symptom score, Visual Analogue Scale, Functional Dyspepsia-related Quality of Life, Electrogastrography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banhasasim-tangDietary supplement
Also called Brand names : Bansasin granules
Form : granules Contents : It consists of seven Herbs. It contains Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma Dosage and frequency : 9g per day (three times a day) Route of administration : Oral Administration duration : 42 days in the study
Corn-starch granulesDietary supplement
Also called Corn-starch granules with herb decoctions flavor
This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.
| Study group | Role | What they receive |
|---|---|---|
| Banhasasim-tang | Experimental | Not described Receives: Dietary Supplement: Banhasasim-tang |
| Placebo drug | Placebo comparator | The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula Receives: Dietary Supplement: Corn-starch granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish
Secondary outcomes (3)
Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia
Measured: Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish
Functional Dyspepsia-related Quality of Life (FD-QoL)
Measured: Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish
Electrogastrography (EGG)
Measured: Baseline, 6 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Health Industry Development Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jin-sung Kim, Korea Health Industry Development Institute
- Investigators
- Jin-sung Kim, Ph.D, Principal investigator, Kyung Hee University Medical Center Oriental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987805
- Sponsor's protocol ID
- B090029
- Other IDs
- ISRCTN51910678
- Status last verified
- Jun 2012
- First submitted
- 30 Sep 2009
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20670451
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial
- ClinicalTrials.gov ID
- NCT00987805
- Acronym / sponsor ID
- B090029
- Conditions
- Functional Dyspepsia
- Keywords
- Functional dyspepsia, Banhasasim-tang, Gastrointestinal Symptom score, Visual Analogue Scale, Functional Dyspepsia-related Quality of Life, Electrogastrography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Korea Health Industry Development InstituteOther government
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Usually having used for dyspepsia in asia
- Need for correct clinical information by RCT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Banhasasim-tang | Experimental | Dietary Supplement: Banhasasim-tang |
| Placebo drug | Placebo comparator | Dietary Supplement: Corn-starch granulesThe placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Typical functional dyspepsia according to ROME III criteria.
- The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms
- Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks
- Written and informed consent
Key exclusion criteria (12 listed)
- History of peptic ulcer or gastroesophageal reflux disease(GERD)
- Current prominent symptoms of irritable bowel syndrome or GERD
- Presence of the following alarm symptoms:
- Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders
- Women in pregnancy and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Banhasasim-tangAlso: Brand names : Bansasin granulesForm : granules Contents : It consists of seven Herbs. It contains Rhizoma Pinelliae, Radix Scutellariae, Zingiberis Rhizoma, Panax ginseng, Glycyrrhiza uralensis Fisch, Zizyphi Fructus and Coptidis Rhizoma Dosage and frequency : 9g per day (three times a day) Route of administration : Oral Administration duration : 42 days in the study | Dietary supplement | Banhasasim-tang |
| Corn-starch granulesAlso: Corn-starch granules with herb decoctions flavorThis placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention. | Dietary supplement | Placebo drug |
Primary outcome
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)
Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish
3 secondary outcomes
Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia
Time frame: Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish
Functional Dyspepsia-related Quality of Life (FD-QoL)
Time frame: Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish
Electrogastrography (EGG)
Time frame: Baseline, 6 weeks after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
- Derived from this study: PubMed 20670451Park 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.
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Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
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Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-sung Kim, Ph.D principal investigator
Kyung Hee University Medical Center Oriental Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Banhasasim-tang and Corn-starch granules in people with Functional Dyspepsia, run by Korea Health Industry Development Institute at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00987805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.