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The long-term effectiveness, safety and economic evaluation of Guanxinning tablet for coronary artery disease: A multicenter, open label clinical trial
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注册号:

Registration number:

ChiCTR-IIR-17010688 

最近更新日期:

Date of Last Refreshed on:

2017-02-20 

注册时间:

Date of Registration:

2017-02-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价冠心宁片长期治疗冠心病患者的有效性、安全性和经济性的多中心、开放性临床试验 

Public title:

The long-term effectiveness, safety and economic evaluation of Guanxinning tablet for coronary artery disease: A multicenter, open label clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价冠心宁片长期治疗冠心病患者的有效性、安全性和经济性的多中心、开放性临床试验 

Scientific title:

The long-term effectiveness, safety and economic evaluation of Guanxinning tablet for coronary artery disease: A multicenter, open label clinical trial 

研究课题代号(代码):

Study subject ID:

 

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:

李金根 

研究负责人:

徐浩,高蕊 

Applicant:

Jin-gen Li 

Study leader:

Hao Xu, Rui Gao 

申请注册联系人电话:

Applicant telephone:

+86 18301103098 

研究负责人电话:

Study leader's telephone:

+86 18601081161 

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:

lijingen198908@126.com 

研究负责人电子邮件:

Study leader's E-mail:

xuhaotcm@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市海淀区西苑操场1号院西苑医院住院部心血管一科 

研究负责人通讯地址:

北京市海淀区西苑操场1号院西苑医院住院部心血管一科  

Applicant address:

1 Xiyuan Caochang, Haidian District, Beijing, China 

Study leader's address:

1 Xiyuan Caochang, Haidian District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100091 

研究负责人邮政编码:

Study leader's postcode:

100091 

申请人所在单位:

中国中医科学院西苑医院 

Applicant's institution:

Xiyuan Hospital, 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:

2016XL010-2 

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:

中国中医科学院西苑医院医学伦理委员会 

Name of the ethic committee:

Ethics committee of Chinese Academy of Traditional Chinese Medicine, Xiyuan Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-11-24 

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:

中国中医科学院西苑医院 

Primary sponsor:

Xiyuan Hospital, China Academy of Chinese Medical Sciences  

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号院西苑医院 

Primary sponsor's address:

1 Xiyuan Caochang, Haidian 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):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

正大青春宝药业有限公司

具体地址:

浙江省杭州市西溪路551号

Institution
hospital:

Chiatai Qingchunbao Pharmaceutical CO.LTD.

Address:

551 Xixi Road, Hangzhou, Zhejiang

经费或物资来源:

正大青春宝药业有限公司 

Source(s) of funding:

Chiatai Qingchunbao Pharmaceutical CO.LTD. 

研究疾病:

冠状动脉粥样硬化性心脏病 

Target disease:

coronary artery disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

IV期临床试验 

Study phase:

研究目的:

通过临床试验,考察冠心宁片对于冠心病患者长期治疗后预防主要不良心脑血管事件发生的有效性、安全性和经济性。 

Objectives of Study:

To evaluate the long-term effectiveness,safety,cost-effectiveness and cost-utility of Guanxinning tablet for preventing major adverse cardiovascular events in patients with coronary artery disease. 

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:

⑴ 经皮冠状动脉介入治疗术后,已接受双联抗血小板治疗(阿司匹林+氯吡格雷或替格瑞洛)12个月以上,且改为阿司匹林单抗治疗满1个月的稳定性冠心病患者; ⑵ 中医证属心血瘀阻者; ⑶ 年龄在18~80岁之间,男女不限; ⑷ 自愿参与本试验,并签署知情同意书。 

Inclusion criteria

(1) Patients with stable coronary artery disease who have undergone PCI and have began antiplatelet therapy with aspirin alone for at least 1 month after over 12 months dual antiplatelet therapy ( aspirin plus clopidogrel or ticagrelor; (2) diagnosed as TCM pattern of heart blood stasis; (3) aged between 18 to 80 years old regardless of gender; (4) voluntary to participate and providing written informed consents. 

排除标准:

⑴ 心功能Ⅳ级(NYHA分级法)的患者。 ⑵ 合并未控制的Ⅲ级高血压(收缩压≥180mmHg和/或舒张压≥110mmHg),重度心肺功能不全,严重的心律失常,肝、肾及造血系统等严重原发性疾病者,或影响其生存的严重疾病(如肿瘤等)及精神病患者。 ⑶ 合并其它可能导致出血风险增加的临床情况,如近半年重要脏器出血史(如脑出血、上消化道出血等)、血小板计数降低、凝血功能异常、正在口服华法林抗凝治疗等。 ⑷ 肝、肾功能指标异常者(ALT、AST、Scr超出正常参考范围上限1.5倍)。 ⑸ 过敏体质,或对多种药物食物过敏者,或已知对试验药(包括其组方成份)过敏的患者。 ⑹ 有妊娠计划者或妊娠、哺乳期妇女。 ⑺ 近1个月内参加其它临床试验的患者。 

Exclusion criteria:

1. patients with heart failure of NYHA IV; 2. Uncontrolled blood pressure, with a systolic blood pressure ≥180 mmHg or a diastolic blood pressure≥100 mmHg, combined with severe cardiopulmonary insufficiency,severe arrythmia,Severe primary hepatic, renal, hematologic, mental disorders or fatal disease like cancer; 3. high bleeding risk,such as history of hemorrage of vital organs (brain or upper gastrointestinal tract) within 6 months,low platelet counts,abnormal coagulation function,currently taking warfarin,etc.; 4. serum level of ALT,AST or Scr >1.5 times upper limit of normal; 5. Allergic constitution,allergic to multiple food or drugs or allergic to the trial drug; 6. Pregnant, planning to pregnant or lactating women; 7. participating another clinical trial within 1 month. 

研究实施时间:

Study execute time:

From2016-08-31To 2019-09-30 

干预措施:

Interventions:

组别:

试验组

样本量:

2400

Group:

Intervention group

Sample size:

干预措施:

冠心宁片+西医常规治疗

干预措施代码:

Intervention:

Guanxinning Tablet+conventional treatment

Intervention code:

组别:

对照组

样本量:

1200

Group:

Control group

Sample size:

干预措施:

西医常规治疗

干预措施代码:

Intervention:

conventional 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):

中国中医科学院西苑医院 

单位级别:

三甲医院 

Institution
hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

河南省 

市(区县):

 

Country:

China 

Province:

Henan province 

City:

 

单位(医院):

洛阳市第一中医院 

单位级别:

三甲医院 

Institution
hospital:

Luoyang NO.1 hospital of traditional Chinese medicine  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei province 

City:

 

单位(医院):

黄冈市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Huanggang central hospital  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei province 

City:

 

单位(医院):

湖北省人民医院 

单位级别:

三甲医院 

Institution
hospital:

Hubei general hospital  

Level of the institution:

Tertiary A hosptal 

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 hosptal 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海曙光医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Shuguang hospital  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan province 

City:

 

单位(医院):

四川华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

贵州 

市(区县):

贵阳 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵阳中医学院第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

Guizhou province hospital of traditional Chinese medicine  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

徐州 

Country:

China 

Province:

Jiangsu province 

City:

Xuzhou 

单位(医院):

江苏徐州医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

The affiliated hospital of Xuzhouhou medical university  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市中医院(浙江中医药大学附属广兴医院) 

单位级别:

三级甲等 

Institution
hospital:

Hangzhou hospital of traditional Chinese medicine  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省立同德医院 

单位级别:

三级甲等 

Institution
hospital:

Tongde hospital of Zhejiang province  

Level of the institution:

Tertiary A hosptal 

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:

Zhejiang provincial hospital of TCM  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Hospital  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京阜外医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Fuwai hospital  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院望京医院 

单位级别:

三级甲等 

Institution
hospital:

Wangjing hospital of CACMS  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中日友好医院 

单位级别:

三级甲等 

Institution
hospital:

China-Japan friendship hospital  

Level of the institution:

Tertiary A hosptal 

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai TCM-integrated hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市南开医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Nankai hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The second affiliated hospital of Tianjin university of TCM  

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):

哈尔滨医科大学第四附属医院 

单位级别:

三级甲等 

Institution
hospital:

The forth affiliated hospital of Harbin medical university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

济南市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Jinan Central Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

济南市第五人民医院 

单位级别:

二级甲等 

Institution
hospital:

Fifth Renmin hospital of Jinan  

Level of the institution:

second A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

陕西中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The second affiliated hospital of Shanxi university of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属上海市第五人民医院 

单位级别:

三甲医院 

Institution
hospital:

The Fifth People's Hospital of Shanghai, Fudan  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

广西瑞康医院 

单位级别:

三级甲等 

Institution
hospital:

Ruikang hospital affiliated to Guangxi University of Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

广西医科大第四附属医院 

单位级别:

三级甲等 

Institution
hospital:

the forth affiliated hospital of Guangxi medical university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中山市人民医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongshan People's Hospital of Guangdong Province  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江西 

市(区县):

 

Country:

China 

Province:

Jiangxi 

City:

 

单位(医院):

南昌市第一医院 

单位级别:

三级甲等 

Institution
hospital:

The first hospital of Nanchang  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属龙华医院 

单位级别:

三级甲等 

Institution
hospital:

Longhua Hospital, Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江温州市中医院 

单位级别:

三级乙等 

Institution
hospital:

Wenzhou hospital of TCM  

Level of the institution:

Tertiary B hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

福建省中医药研究院 

单位级别:

三级甲等 

Institution
hospital:

Institute of Traditional Chinese Medicine of Fujian Province  

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):

长沙市第三医院 

单位级别:

三级甲等 

Institution
hospital:

The third hospital of Changsha  

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):

湖南中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The first hospital of Hunan university of Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

无锡市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Wuxi hospital of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

内蒙古自治区 

市(区县):

 

Country:

China 

Province:

Inner Mongolia Autonomous Region  

City:

 

单位(医院):

内蒙古蒙医国际医院 

单位级别:

三级甲等 

Institution
hospital:

Inner Mongolia international mongolian hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市同济医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Tongji Hosopital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津海河医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin Haihe Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

盐城市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Yancheng City No.1 People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河北 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

保定市第一中医院 

单位级别:

三级甲等 

Institution
hospital:

Baoding No.1 Hospital of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

主要不良心脑血管事件复合发终点生率(心血管死亡、非致命性心肌梗死、支架血栓、血运重建、缺血性脑卒中和因不稳定心绞痛住院)

指标类型:

主要指标 

Outcome:

composite major adverse cardiovascular events(cardiovascular death, non-fatal myocardial infarction, stent thrombosis, revascularization, ischemic stroke and rehospitalization due to unstable angina)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全因死亡率

指标类型:

次要指标 

Outcome:

all-cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心血管死亡

指标类型:

次要指标 

Outcome:

cardiovascular death

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非致命性心肌梗死

指标类型:

次要指标 

Outcome:

non-fatal myocardial infarction

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

支架血栓

指标类型:

次要指标 

Outcome:

stent thrombosis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血运重建

指标类型:

次要指标 

Outcome:

revascularization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

缺血性卒中

指标类型:

次要指标 

Outcome:

ischemic stroke

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

因不稳定性心绞痛住院

指标类型:

次要指标 

Outcome:

rehospitalization due to unstable angina

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

硝酸甘油停减率

指标类型:

次要指标 

Outcome:

nitroglycerin discontinue 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:

西雅图心绞痛量表

指标类型:

次要指标 

Outcome:

Seattle Angina Questionnaire

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

健康调查简表(SF-36)

指标类型:

次要指标 

Outcome:

the MOS item short from health survey

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血小板聚集试验

指标类型:

附加指标 

Outcome:

platelet aggregation test

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高敏C反应蛋白

指标类型:

附加指标 

Outcome:

high-sensitivity C-reactive protein

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出血事件发生率

指标类型:

副作用指标 

Outcome:

hemorrhage rate

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应(症状、体征)

指标类型:

副作用指标 

Outcome:

adverse events

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一般体格检查(身高、体重、体温、血压、心率、呼吸等)

指标类型:

副作用指标 

Outcome:

general physical examination( height, weight, temperature, blood pressure, breath, etc)

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

副作用指标 

Outcome:

routine blood test

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标 

Outcome:

routine urine test

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便常规

指标类型:

副作用指标 

Outcome:

routine stool test

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

副作用指标 

Outcome:

ALT、AST、ALP、GGT、TBIL、DBIL, BUN, Scr

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

electrocardiogram

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血功能

指标类型:

副作用指标 

Outcome:

coagulation function

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

妊娠试验

指标类型:

副作用指标 

Outcome:

pregnant test

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

成本

指标类型:

次要指标 

Outcome:

cost

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:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

采用SAS产生的随机数字表产生随机随机序列(将参与中心进行了随机分配)

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

The random number sequence is generated by random number table which is generated by SAS 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:

Within six months after the trial complete

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):

*

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

*

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:

中国中医科学院西苑医院药物临床试验数据管理系统

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

clinical trial and drug data management system of Xiyuan Hospital of 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:

 2017-02-20
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