Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:51 PM
Study NCT ID:
NCT01926834
Status:
UNKNOWN
Last Update Posted:
2013-08-21
First Post:
2013-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002544', 'term': 'Cerebral Infarction'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D000074584', 'term': 'WW Domain-Containing Oxidoreductase'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000074583', 'term': 'Short Chain Dehydrogenase-Reductases'}, {'id': 'D064430', 'term': 'NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases'}, {'id': 'D000429', 'term': 'Alcohol Oxidoreductases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D025521', 'term': 'Tumor Suppressor Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2013-08-19', 'lastUpdatePostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the serum level of VEGF,MMP-9 and EPC', 'timeFrame': '0-7days'}], 'secondaryOutcomes': [{'measure': 'National Institute of Health of stroke scale', 'timeFrame': '0-7days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['promoting angiogenesis in multiple targets', 'herbal medicine', 'traditional chinese medicine', 'random clinical trial'], 'conditions': ['Cerebral Infarction']}, 'descriptionModule': {'briefSummary': 'To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction,test is made by random double-blind controlled.patients with acute cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin group,and health people. The main indexes are the serum level of VEGF, MMP-9 and EPC.The review is made by the reference to NIHSS and so on. So, Erigeron Injection have the function of promoting angiogenesis in multiple targets through this test.', 'detailedDescription': 'OBJECTIVE:\n\nTo study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction.\n\nMETHOD:\n\n40 patients with acute cerebral infarction(in accordance with the inclusion criteria) were divided randomly into erigeron injection+aspirin group,aspirin group,and 20 health people. Erigeron injection+aspirin group and aspirin group drew peripheral blood on the prior treatment,the posttreatment 1th, 3th and 7th day,and tested the level of VEGF, MMP-9 and EPC.Tested the health people one time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged no younger than 18yrs\n* attack within 72 hours\n* NIHSS score in the 2-25 points\n* Ischemic Stroke occurred for the first time, or with a history of stroke disease but without sequelae\n* Signed the informed consents\n\nExclusion Criteria:\n\n* patients aged younger than 18yrs\n* Patients with tumor, coronary heart disease, valvular heart disease, psoriasis, rheumatism, hematologic diseases, infertility, varieties of acute inflammation\n* Patients with severe cognitive impairment\n* Refused to cooperate or been unable to cooperation for neurological disorders\n* Cerebral hemorrhage or hemorrhagic cerebral infarction\n* Unstable vital signs dued to massive cerebral infarction\n* Patients with serious heart, liver and renal insufficiency'}, 'identificationModule': {'nctId': 'NCT01926834', 'briefTitle': 'The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou University of Traditional Chinese Medicine'}, 'officialTitle': 'The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels', 'orgStudyIdInfo': {'id': '1201/01/006284'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erigeron Injection', 'description': 'Erigeron Injection, 30ml,qd,i.v., for 7 days', 'interventionNames': ['Drug: Erigeron Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'normal saline, 500ml,i.v.,qd, for 7 days', 'interventionNames': ['Drug: placebo']}, {'type': 'NO_INTERVENTION', 'label': 'health volunteers', 'description': 'health volunteers, no drug to be given.'}], 'interventions': [{'name': 'Erigeron Injection', 'type': 'DRUG', 'description': 'Erigeron Injection, 30ml, iv, qd, for 7days', 'armGroupLabels': ['Erigeron Injection']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['normal saline, 500ml,i.v.,qd, for 7 days'], 'description': 'normal saline, 500ml,i.v.,qd, for 7 days', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jianwen Guo, doctor', 'role': 'CONTACT', 'email': 'jianwen_guo@msn.com', 'phone': '0086-13724899379'}, {'name': 'Yefeng Cai, master', 'role': 'CONTACT', 'email': 'caiyefeng@126.com', 'phone': '(08620)81887233', 'phoneExt': '34530'}], 'overallOfficials': [{'name': 'Jianwen m Guo, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Province Hospital of Tradtional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}