Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-01 @ 10:00 PM
Study NCT ID:
NCT00789269
Status:
UNKNOWN
Last Update Posted:
2010-05-28
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630126', 'term': 'rhubarb peony decoction'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2008-11-10', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The lung infection rate within 14 days after stroke onset', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Global disability on modified Rankin scale', 'timeFrame': '90 days'}, {'measure': 'NIH stroke scale', 'timeFrame': '90 days'}, {'measure': 'Barthel Index', 'timeFrame': '90 days'}, {'measure': 'Death rate', 'timeFrame': '90 days'}, {'measure': 'Syndrome score by Traditional Chinese Medicine (TCM) standard', 'timeFrame': '90 days'}, {'measure': 'Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, etc.', 'timeFrame': '90 days'}]}, 'conditionsModule': {'keywords': ['lung infection after ischemic Stroke', 'prevention of pneumonia', 'rhubarb'], 'conditions': ['Pneumonia', 'Acute Stroke']}, 'descriptionModule': {'briefSummary': 'This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute stroke. The study is designed to look at both infection rate and overall recovery and recovery of motor function, for example muscle strength and coordination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with a score of at least 6 on the National Institute of Health Stroke Scale (NIHSS), and patient age of at least 18 years.\n* Have no pneumonia according to modified criteria of the U.S. Centers for Disease Control and Prevention (CDC)\n* Consistent with the Constipation of Phlegm-Heat Accumulation type by Traditional Chinese Medicine (TCM) standard\n* Patients or their representatives voluntarily take part in this study and signed the informed consent\n\nExclusion Criteria:\n\n* Cerebral hemorrhage, subarachnoid hemorrhage\n* Transient ischemic attack(TIA)\n* Proven cerebral embolism caused by tumor, Brain Trauma, cerebral parasitic disease, dysbolismus, fibrillation atrial resulted from rheumatic heart disease, coronary heart disease, and other heart diseases\n* Clinical signs of infection on admission\n* Pregnant or breast-feeding\n* Allergic to rhubarb\n* Preceding or ongoing antibiotic therapy within the last 24 h\n* Participation in another interventional trial\n* Immunosuppressant treatment within the last 30 days\n* Combining severe clinical conditions such as liver, kidney, Hematopoietic System, endocrine system or psychological diseases'}, 'identificationModule': {'nctId': 'NCT00789269', 'briefTitle': 'Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'orgStudyIdInfo': {'id': 'rhubarb ischemia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'rhubarb', 'interventionNames': ['Drug: rhubarb']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'rhubarb', 'type': 'DRUG', 'description': '14 days of rhubarb', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': '14 days of placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Integrative Medicine, Zhongshan hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zhongshan hospital, Fudan University', 'oldOrganization': 'TCM department, Zhongshan hospital, Fudan University'}}}}