注册号: Registration number: |
ChiCTR-TRC-09000526 |
最近更新日期: Date of Last Refreshed on: |
2015-05-15 |
注册时间: Date of Registration: |
2009-09-08 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
华佗再造丸治疗脑梗死恢复期有效性和安全性临床再评价研究 |
Public title: |
A controlled Trial to evaluate the efficacy and safety of HUATUO ZAIZAO PILLS for the recovery phase of cerebral infarction |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
华佗再造丸治疗脑梗死恢复期有效性和安全性临床再评价研究 |
Scientific title: |
A controlled Trial to evaluate the efficacy and safety of HUATUO ZAIZAO PILLS for the recovery phase of cerebral infarction |
研究课题代号(代码): Study subject ID: |
HTZZW |
在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
武红莉 |
研究负责人: |
王忠 |
Applicant: |
Hongli Wu |
Study leader: |
Zhong Wang |
申请注册联系人电话: Applicant telephone: |
+86 010 64014411-2802 |
研究负责人电话: Study leader's telephone: |
+86 010 64014411 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
thisyear2006@126.com |
研究负责人电子邮件: Study leader's E-mail: |
zhonw@vip.sina.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
http://www.catcm.ac.cn |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
http://www.catcm.ac.cn |
申请注册联系人通讯地址: |
北京市东直门内南小街16号 |
研究负责人通讯地址: |
北京市东直门内南小街16号 |
Applicant address: |
No.16, Nanxiaojie, Dongzhimen nei, Beijing City |
Study leader's address: |
No.16, Nanxiaojie, Dongzhimen nei, Beijing City |
申请注册联系人邮政编码: Applicant postcode: |
100700 |
研究负责人邮政编码: Study leader's postcode: |
100700 |
申请人所在单位: |
中国中医科学院临床基础医学研究所 |
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Applicant's institution: |
Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
20090729 |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
北京中医药大学东直门医院医学伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Dongzhimen hospital affiliated to Beijing university |
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伦理委员会批准日期: Date of approved by ethic committee: |
2009-07-29 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
中国中医科学院临床基础医学研究所 |
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Primary sponsor: |
Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences |
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研究实施负责(组长)单位地址: |
北京市东直门内南小街16号 |
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Primary sponsor's address: |
No.16, Xiao Nan Jie, Dongzhimen Nei, Beijing City |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
国家自然科学基金、企业资助 |
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Source(s) of funding: |
National natural science foundation of China |
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研究疾病: |
脑梗死恢复期 |
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Target disease: |
the recovery phase of cerebral infarction |
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研究疾病代码: |
ICD:I63.9 |
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Target disease code: |
ICD:I63.9 |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
上市后药物 | ||||||||||||||||||||||
Study phase: |
4 |
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研究目的: |
进一步研究华佗再造丸治疗脑梗死恢复期的适应证侯及在中风病二级预防中的作用,评价其治疗脑梗死恢复期的临床有效性和安全性 |
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Objectives of Study: |
To study the indicated syndrome of HUATUO ZAIZAO PILLS in the treatment of the recovery phase of cerebral infarction,and the effect in secondary prevention of stroke; To evaluate the efficacy and safety of HUATUO ZAIZAO PILLS in the treatment of the recovery phase of cerebral infarction. |
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药物成份或治疗方案详述: |
吴茱萸 冰片 川芎 其他 |
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Description for medicine or protocol of treatment in detail: |
Chuanxiong rhizome Evodia fruit,etc |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
1符合西医脑梗死诊断标准;2符合中医中风病中经络诊断标准;3年龄在40岁以上,75岁以下者;4中风病发病2周~1个月者;5志愿受试,并签署知情同意书者 |
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Inclusion criteria |
1. Cerebral infarction according to the diagnosis in Western Medicine; 2. Apoplexy involving the meridians according to the diagnosis in Traditional Chinese Medicine; 3. In the recovery phase of stroke: between 2 weeks and 1 month after the onset; 4. Aged 40 to 75 years old; 5. Able and willing to provide signed informed consent. |
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排除标准: |
1短暂性脑缺血发作(TIA);2中风病中脏腑者;3脑出血;4年龄在40岁以下或75岁以上者;5妊娠期或哺乳期妇女;6已知对本药物成分过敏及过敏体质者;7经检查证实由脑肿瘤、脑外伤、血液病等引起的卒中患者,因风湿性心脏病、冠心病及其他心脏病合并房颤,引起脑栓塞者;8合并有肝、肾、造血系统、内分泌系统等严重疾病及骨关节病、精神病者;9正在参加其它药物临床试验者。 |
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Exclusion criteria: |
1. patients with cerebral transient ischemic attack(TIA); 2. Apoplexy involving the viscera; 3. patients with cerebral hemorrhage; 4. Pregnant or breast-feeding women; 5. allergic constitution or history of hypersensitivity to HUATUO ZAIZAO PILLS; 6. Apoplexy caused by cerebral tumour, cerebral trauma,and hemopathy, and cerebral embolism caused by rheumatic heart disease, coronary heart disease with atrial fibrillation, confirmed by examinations; 7. Patients with psychotic diseases Patients with serious hepatic, renal, orhematological, Endocrine disease, osteoarthrosis or psychotic diseases; 8. Patients that are taking part in other clinical trials. |
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研究实施时间: Study execute time: |
从From2009-06-01至To 2011-12-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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