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Randomized, Multicenter, Parallelcontrol study on evaluation for the clinical effectiveness of Angong Niuhuang Boluses against Stroke with phlegmy heat symptom-complex
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注册号:

Registration number:

ChiCTR-TRC-10001016 

最近更新日期:

Date of Last Refreshed on:

2015-06-22 

注册时间:

Date of Registration:

2010-09-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

安宫牛黄丸治疗中风病急性期(痰热证)随机、多中心、平行对照临床研究 

Public title:

Randomized, Multicenter, Parallelcontrol study on evaluation for the clinical effectiveness of Angong Niuhuang Boluses against Stroke with phlegmy heat symptom-complex 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

显示中医药疗效优势的中药临床药效评价关键技术研究 

Scientific title:

Research of Key Techniques on Evaluation for the clinical effectiveness of chinese herbal medicine which can take the advantage on the effectiveness of traditional chinese medicine 

研究课题代号(代码):

Study subject ID:

2009ZX09502-028 

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:

张杨 

研究负责人:

高颖 

Applicant:

Zhang Yang 

Study leader:

GaoYing 

申请注册联系人电话:

Applicant telephone:

+86 15811042215 

研究负责人电话:

Study leader's telephone:

+86 10 84013209 

申请注册联系人传真 :

Applicant Fax:

+86 10 84013351 

研究负责人传真:

Study leader's fax:

+86 10 84013351 

申请注册联系人电子邮件:

Applicant E-mail:

java-zy@163.com 

研究负责人电子邮件:

Study leader's E-mail:

gaoying973@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.dzmhospital.com 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

www.dzmhospital.com 

申请注册联系人通讯地址:

北京市东城区海运仓5号东直门医院神经内科 

研究负责人通讯地址:

北京市东城区海运仓5号东直门医院神经内科 

Applicant address:

Neurology Department of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, No.5, Hai Yun Cang, Dongcheng District, Beijing, China 

Study leader's address:

Neurology Department of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, No.5, Hai Yun Cang, Dongcheng District, Beijing, China 

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:

北京中医药大学东直门医院 

Applicant's institution:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

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:

ECPJ-BDY-2010-012 

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:

Medical Ethics Committee of Dongzhimen Hospital affiliated to Beijing University of Chines Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2010-09-06 

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:

北京中医药大学 

Primary sponsor:

Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

北京市朝阳区北三环东路11号北京中医药大学 

Primary sponsor's address:

Beijing University of Chinese Medicine, No.11, Bei San Huan Dong Road, Chaoyang District, Beijing, China 

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:

China

City:

单位(医院):

科技部

具体地址:

科技部

Institution
hospital:

Ministry of Science and Technology of China.

Address:

Ministry of Science and Technology of China.

经费或物资来源:

国家科技重大专项“重大新药创制” 

Source(s) of funding:

State major science and technology special projects 

研究疾病:

脑梗死 

Target disease:

Ischemic stroke 

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:

通过安宫牛黄丸干预中风病痰热证,以建立科学、规范、客观、准确的针对证候及病证结合的中药临床疗效评价的现代技术方法,以此提高中药疗效评价的技术水平;对安宫牛黄丸治疗脑梗死急性期“痰热证”临床有效性及其对预后的影响进行客观准确评价。 

Objectives of Study:

The Purpose of the research is to establish a scientific, standardized, objective and accurate methods of modern technology for evaluating the clinical effectiveness of Chinese herbal medicine within TCM syndromes, and also improve the evaluation level of the clinical effectiveness of Chinese herbal medicine. To make a objective and accurate evaluation for the clinic effectiveness and prognosis of acute stroke with phlegmy heat symptom-complex treated by Angong Niuhuang Boluses. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

符合西医脑梗死诊断;中医证候诊断符合《缺血性中风证候要素诊断量表》“痰证”和“热证”诊断同时成立;或诊断为中风病中脏腑阳闭证;年龄≥35岁且≤80岁;发病在48小时以内;NIHSS分值≥5分。 

Inclusion criteria

1. Patients who present within ischemic stroke whithin 48 hours; 2. Age between 35 and 80; 3. Suitable for the the syndrome diagnosis of phlegmy syndrome and heat syndrome through "Ischemic Stroke TCM Syndrome Factor Diagnostic Scale" (ISTSFDS) or the syndrome diagnosis of yang block syndrome of Stoke of Bowel and viscerae, are eligible for this study; 4. National Institute of Health Stroke Scale (NIHSS) scores >5. 

排除标准:

短暂性脑缺血发作(Transient Ischemic Attack ,TIA);脑出血或蛛网膜下腔出血;超早期(3~6h内)已接受溶栓治疗者;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;合并有肝、肾、造血系统、内分泌系统等严重疾病及骨关节病;精神障碍或严重痴呆;有卒中病史且遗留后遗症者影响观察测评。 

Exclusion criteria:

1. Patients who receive treatment of ischemic stroke by thrombolysis in Ultra-early stage; 2. Complicated with hepatic, kidney, hematological, endocrine, osteoarthropathy disease, mental disorder, serious dementia or sequela of apoplexy; 3. Transient ischemic attack, intracranial hemorrhage or subarachnoid hemorrhage; 4. Rheumatic heart disease,coronary heart disease or other heart diseases complicated by atrial fibrillation disease; 5. Brain tumor, brain trauma and hematological diseases result in cerebral embolism. 

研究实施时间:

Study execute time:

From2010-10-01To 2011-03-31 

干预措施:

Interventions:

组别:

试验组

样本量:

110

Group:

Group A

Sample size:

干预措施:

内科基础治疗+安宫牛黄丸

干预措施代码:

Intervention:

Basic therapy + Angong Niuhuang Boluses

Intervention code:

组别:

对照组

样本量:

110

Group:

Group B

Sample size:

干预措施:

内科基础治疗

干预措施代码:

Intervention:

Basic therapy

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):

北京中医药大学东直门医院 

单位级别:

三级甲等 

Institution
hospital:

Dongzhimen hospital affiliated to beijing university of chines medicine  

Level of the institution:

Tertiary 

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:

三级甲等 

Institution
hospital:

First Hospital Affiliated to Anhui University of Chinese Medicine  

Level of the institution:

Tertiary 

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:

三级甲等 

Institution
hospital:

Oriental Hospital affiliated to Beijing University of Chinese Medicine  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

广东 

市(区县):

佛山 

Country:

China 

Province:

Guangdong 

City:

foshan 

单位(医院):

广东省佛山市中医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese Medicine Hospital of Foshan City, Guangdong Province  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

广东 

市(区县):

江门 

Country:

China 

Province:

Guangdong 

City:

Jiangmen 

单位(医院):

广东省江门市五邑中医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese Medicine Hospital of Wuyi, Jiangmen City, Guangdong Province  

Level of the institution:

Tertiary 

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:

三级甲等 

Institution
hospital:

Chinese medicine hospital in Hubei Province  

Level of the institution:

Tertiary 

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:

三级甲等 

Institution
hospital:

Chinese medicine hospital in Henan  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南中医学院第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

First Hospital Affiliated to Henan University of Chinese  

Level of the institution:

Tertiary 

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):

吉林省长春中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital Affiliated to Changchun University of Chinese Medicine  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

陕西中医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital Affiliated to Shanxi University of Chinese Medicine  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省中医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese medicine hospital in Zhejiang Province  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

发病90天改良Rankin量表

指标类型:

主要指标 

Outcome:

Modified rankin scale Score of stroke 90th day

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发病14天中医证候

指标类型:

主要指标 

Outcome:

"Ischemic Stroke TCM Syndrome Factor Diagnostic at day 14 of onset the stroke

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发病14天NIHSS

指标类型:

主要指标 

Outcome:

NIHSS score of stroke 14th day

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发病90天BI

指标类型:

次要指标 

Outcome:

BI score of stroke on the 90th day after onset

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发病14天及90天病死率

指标类型:

附加指标 

Outcome:

PRO score of stroke 14TH AND 90th day

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

昏迷转化率

指标类型:

附加指标 

Outcome:

The rate of coma transfer

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发病14天及90天中风病基于患者报告的临床结局评价量表

指标类型:

附加指标 

Outcome:

THE mortality of stroke 14TH AND 90th day

Type:

Additional 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 35 years
最大 Max age 80 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:

Blinding:

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):

北京中医药大学东直门医院

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

Dongzhimen Hospital affiliated to Beijing University of Chines Medicine

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:

北京中医药大学东直门医院临床研究中心

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

Clinical Research Center of Dongzhimen Hospital affiliated to Beijing University of Chines Medicine

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-09-22
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