Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 9:52 PM
Study NCT ID:
NCT00987805
Status:
COMPLETED
Last Update Posted:
2012-06-21
First Post:
2009-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Banhasasim-tang on Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-20', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 6 weeks after administration, 4 and 8 weeks after treatment finish'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS) for overall discomfort due to dyspepsia', 'timeFrame': 'Baseline, 2weeks, 4weeks, 6weeks after administration, 4 and 8 weeks after treatment finish'}, {'measure': 'Functional Dyspepsia-related Quality of Life (FD-QoL)', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, and 6 weeks after administration, 4 and 8 weeks after treatment finish'}, {'measure': 'Electrogastrography (EGG)', 'timeFrame': 'Baseline, 6 weeks after administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Functional dyspepsia', 'Banhasasim-tang', 'Gastrointestinal Symptom score', 'Visual Analogue Scale', 'Functional Dyspepsia-related Quality of Life', 'Electrogastrography'], 'conditions': ['Functional Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '20670451', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Banhasasim-tang\n\n1. 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.\n2. Usually having used for dyspepsia in asia\n3. Need for correct clinical information by RCT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Typical functional dyspepsia according to ROME III criteria.\n\n * One or more of:\n\n * Bothersome post-prandial fullness\n * Early satiation\n * Epigastric pain\n * Epigastric burning\n * No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms\n2. The presence of 'moderate' as the degree of severity for at least three Gastrointestinal Symptom (GIS) score symptoms\n3. Before participation of trial, epigastric pain or discomfort has persisted in a permanent or recurrent form for a minimum period of 12 weeks\n4. Written and informed consent\n\nExclusion Criteria:\n\n1. History of peptic ulcer or gastroesophageal reflux disease(GERD)\n2. Current prominent symptoms of irritable bowel syndrome or GERD\n3. Presence of the following alarm symptoms:\n\n * Severe weight loss\n * Black or tar stool\n * Dysphagia\n4. Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders\n5. Women in pregnancy and lactation\n6. History of gastrointestinal surgery or taking any drugs that may significantly alter digestive system\n7. Participation of other clinical trials within the last 3 months\n8. Severe mental problems or drug abuse\n9. Judged by expert that they are appropriate to participate in this study"}, 'identificationModule': {'nctId': 'NCT00987805', 'briefTitle': 'Efficacy of Banhasasim-tang on Functional Dyspepsia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Korea Health Industry Development Institute'}, 'officialTitle': 'Efficacy of Banhasasim-tang on Functional Dyspepsia : a Randomized, Double Blind, Placebo Controlled, Two-center Trial', 'orgStudyIdInfo': {'id': 'B090029'}, 'secondaryIdInfos': [{'id': 'ISRCTN51910678', 'type': 'OTHER_GRANT', 'domain': 'ISRCTN51910678'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Banhasasim-tang', 'interventionNames': ['Dietary Supplement: Banhasasim-tang']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drug', 'description': 'The placebo of this study is corn-starch granules. It has the same form, color, flavor and amount like experimental herbal extracted formula', 'interventionNames': ['Dietary Supplement: Corn-starch granules']}], 'interventions': [{'name': 'Banhasasim-tang', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Brand names : Bansasin granules'], 'description': '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', 'armGroupLabels': ['Banhasasim-tang']}, {'name': 'Corn-starch granules', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Corn-starch granules with herb decoctions flavor'], 'description': 'This placebo has the same form, color, and flavor as experimental intervention.The dosage, frequency and duration is also same as experimental intervention.', 'armGroupLabels': ['Placebo drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130702', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Medical Center Oriental Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134727', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'East-West Neo Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-sung Kim, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Medical Center Oriental Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Health Industry Development Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Jin-sung Kim', 'investigatorAffiliation': 'Korea Health Industry Development Institute'}}}}