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A controlled Trial to evaluate the efficacy and safety of HUATUO ZAIZAO PILLS for the recovery phase of cerebral infarction
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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:

 

English Acronym:

 

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:

 

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 

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 

Approved by ethic committee:

Yes 

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:

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 

Name of the ethic committee:

Ethics Committee of Dongzhimen hospital affiliated to Beijing university 

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:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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 

Primary sponsor:

Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市东直门内南小街16号 

Primary sponsor's address:

No.16, Xiao Nan Jie, Dongzhimen Nei, Beijing City 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家自然基金会

具体地址:

北京市海淀区双清路83号

Institution
hospital:

National Natural Science Foundation of China

Address:

No.83, Shuangqing Road, Haidian District, Beijing City

经费或物资来源:

国家自然科学基金、企业资助 

Source(s) of funding:

National natural science foundation of China 

研究疾病:

脑梗死恢复期 

Target disease:

the recovery phase of cerebral infarction 

研究疾病代码:

ICD:I63.9 

Target disease code:

ICD:I63.9 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

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 

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. 

药物成份或治疗方案详述:

吴茱萸 冰片 川芎 其他 

Description for medicine or protocol of treatment in detail:

Chuanxiong rhizome Evodia fruit,etc 

研究设计:

随机平行对照 

Study design:

Parallel 

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 

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. 

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。 

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. 

研究实施时间:

Study execute time:

From2009-06-01To 2011-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

360

Group:

Group A

Sample size:

干预措施:

口服阿司匹林肠溶片,100mg/日,每晚1次;口服华佗再造丸,每次4克,每日2次

干预措施代码:

Intervention:

Tablets Acetylsalicylic AcidEntrorosolubilus 100mg, orally taken once daily and HUATUO ZAIZAO PILLS 4g, orally taken twice daily for 6 months . A treating course lasts 6 months.

Intervention code:

组别:

对照组

样本量:

360

Group:

Group B

Sample size:

干预措施:

口服阿司匹林肠溶片,100mg/日,每晚1次;口服华佗再造丸模拟剂,每次4克,每日2次

干预措施代码:

Intervention:

Tablets Acetylsalicylic AcidEntrorosolubilus 100mg, orally taken once daily and the mimetics of HUATUO ZAIZAO PILLS 4g, orally taken twice daily for 6 months . A treating course lasts 6 months.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东方医院 

单位级别:

三甲医院 

Institution
hospital:

Dongfang Hospital, Beijing University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三甲医院 

Institution
hospital:

Dongzhimen hospital affiliated to Beijing university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

Changchun 

单位(医院):

长春中医药大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Changchun University of TCM Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽中医学院第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of the Anhui University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南省中医院 

单位级别:

三甲医院 

Institution
hospital:

Henan Provincial Hospital of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

湖北省中医院 

单位级别:

三甲医院 

Institution
hospital:

Hubei Provincial Hospital of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

辽宁中医药大学附属第二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Affiliated Hospital of Liaoning University Of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江中医药大学附属第二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Affiliated Hospital of Heilongjiang University Of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

湖南省中医药研究院附属医院 

单位级别:

三甲医院 

Institution
hospital:

The Affiliated Hospital of Hunan TCM Institution  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

陕西中医学院附属医院 

单位级别:

三甲医院 

Institution
hospital:

The Affiliated Hospital of Shaanxi University of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

神经功能缺损变化情况

指标类型:

主要指标 

Outcome:

Changes in neurological deficit score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

Changes of syndromes of TCM

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者脑梗死复发率及不良结局发生情况

指标类型:

次要指标 

Outcome:

the incidence of adverse outcomes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

Assessment of clinical outcome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者复发情况

指标类型:

次要指标 

Outcome:

recurrence rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

日常生活能力变化情况

指标类型:

次要指标 

Outcome:

Changes in ability of life score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 75 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

计算机软件

Randomization Procedure (please state who generates the random number sequence and by what method):

Computer Software

盲法:

研究实施者 是 患者 是

Blinding:

Patients: Yes Trialist: Yes

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

中国中医科学院临床基础医学研究所

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

中国中医科学院临床基础医学研究所

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Institute of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2009-09-08
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