ChiCTR-TRC-13003242 版本V1.1 版本创建时间2016/2/7 19:42:55 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-TRC-13003242 

最近更新时间:

Date of Last Refreshed on:

2016/2/7 19:30:04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

鹿红颗粒防治冠心病心功能不全的多中心临床研究 

Public title:

Lu Hong Granule in management of Heart Failure in Coronary Artery Disease patients: A randomized multi-center study. 

注册题目简写:

 

Public title acronym:

LHKL-CAD-HF 

研究课题的正式科学名称:

鹿红颗粒防治冠心病心功能不全的多中心临床研究 

Scientific title:

Integrative Medicine program optimization study in coronary artery disease with heart failure 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

王肖龙 

研究负责人:

王肖龙 

Applicant:

Wang Xiao-long 

Study leader:

Wang Xiao-long 

申请注册联系人电话:

Applicant telephone:

+86 13501991450 

研究负责人电话:

Study leader's telephone:

+86 13501991450 

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:

wxlqy0214@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wxlqy0214@163.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:

上海市普安路185号 

研究负责人通讯地址:

上海市普安路185号 

Applicant address:

185 Pu'an Road, Shanghai 

Study leader's address:

185 Pu'an Road, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海中医药大学附属曙光医院 

Applicant's institution:

Shuguang hospital affiliated to Shanghai university of Traditional 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:

2013-259-28-01 

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:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shuguang hospital affiliated to Shanghai university of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-05-07 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

上海中医药大学附属曙光医院 

Primary sponsor:

Shuguang hospital affiliated to Shanghai university of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市普安路185号 

Primary sponsor's address:

185 Pu'an Road, Luwan District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

上海市卫生局 

Source(s) of funding:

Shanghai Municipal Health Bureau 

研究疾病:

冠心病合并心功能不全 

Target disease:

Coronary artery disease with heart failure 

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:

I期临床试验 

Study phase:

研究目的:

评价鹿红颗粒治疗冠心病合并心功能不全的有效性和安全性 

Objectives of Study:

To evaluate the clinical efficiency and safety on Lu Hong Granule treating coronary artery disease patients with heart failure 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

18-85岁,性别不限;符合冠心病诊断标准;符合左心功能不全诊断标准;鹿红颗粒组符合中医阳虚血瘀证判定标准;符合NYHA分级II-IV级 

Inclusion criteria

Aged from 18-85 with no sex limitation; diagnosis in coronary artery disease with left ventricular dysfunction; Lu Hong Granule treatment group should with TCM diagosis yang deficient and blood stasis; in class II-IV heart failure diagosis by New York Heart Association. 

排除标准:

持续严重心绞痛(CCS Ⅳ级);试验期间准备行CABG或PCI者;肾功能不全(Cr>1.5倍正常参考值上限);严重肝病患者或肝功能不全(ALT、AST或TBIL>2倍正常参考值上限);任何其它严重的疾病或状况如:恶性肿瘤;正在参加另一个临床研究;孕妇或准备怀孕的妇女;研究者判断认为不适合参加本研究的患者 

Exclusion criteria:

persistant severe angina (CCS Class IV); undertaking CABG or PCI surgery during the trial; kidney failure with SCr>1.5*ULN; severe liver disease or abnormal in liver biomarks(ALT, AST or TBil>2* ULN); any other severe disease or situation like malignant tumor; undertaking another clinical trial; pregnant woman or preparing to pregnant; researchers think not being suitable to participate in this study. 

研究实施时间:

Study execute time:

From2013-05-01To 2014-09-21 

干预措施:

Interventions:

组别:

试验组

样本量:

150

Group:

Treatment group

Sample size:

干预措施:

心功能不全标准治疗+鹿红颗粒

干预措施代码:

Intervention:

standard treatment of heart failure+Lu Hong Granule

Intervention code:

组别:

对照组

样本量:

150

Group:

comparison group

Sample size:

干预措施:

心功能不全标准治疗

干预措施代码:

Intervention:

standard treatment of heart failure

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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曙光医院 

单位级别:

三甲 

Institution
hospital:

Shuguang hospital affiliated to Shanghai university of Traditional Chinese Medicine  

Level of the institution:

Tertiary 

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:

三甲 

Institution
hospital:

Longhua hospital affiliated to Shanghai university of Traditional Chinese Medicine  

Level of the institution:

Tertiary 

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:

三甲 

Institution
hospital:

Longhua hospital affiliated to Shanghai university of Traditional Chinese Medicine  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海宝山中西医结合医院 

单位级别:

三甲 

Institution
hospital:

Baoshan Hospital of integrated Traditional Chinese Medinice and Western Medinice.Shanghai  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海东方医院 

单位级别:

三甲 

Institution
hospital:

Shanghai East Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市中医医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海浦东光明中医院 

单位级别:

二甲 

Institution
hospital:

Shanghai Pudong Guangming Hospital of Traditional Chinese Medicine  

Level of the institution:

Secondary level 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市浦东新区张江社区卫生服务中心 

单位级别:

一乙 

Institution
hospital:

Shanghai Zhang Jiang community health center  

Level of the institution:

One B-level 

测量指标:

Outcomes:

指标中文名:

全因死亡

指标类型:

主要指标 

Outcome:

all-cause mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非致死性心肌梗死

指标类型:

主要指标 

Outcome:

Nonfatal myocardial infarction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非致死性脑卒中

指标类型:

主要指标 

Outcome:

Nonfatal 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:

因ACS、心绞痛需介入治疗、需手术治疗

指标类型:

主要指标 

Outcome:

Intervention or surgery therapy caused by ACS or 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:

心衰恶化需住院治疗

指标类型:

主要指标 

Outcome:

Worsening heart failure hospitalization

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈动脉超声

指标类型:

主要指标 

Outcome:

carotid artery ultrasound

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心脏超声

指标类型:

主要指标 

Outcome:

cardiac ultrasound

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑钠肽

指标类型:

主要指标 

Outcome:

BNP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心功能评价

指标类型:

主要指标 

Outcome:

Cardiac function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候评价

指标类型:

主要指标 

Outcome:

TCM symptoms evaluation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效评定

指标类型:

主要指标 

Outcome:

Efficacy evaluation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件与不良反应

指标类型:

次要指标 

Outcome:

blood routine test

Type:

Secondary indicator 

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:

次要指标 

Outcome:

urine routine test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6分钟步行试验

指标类型:

次要指标 

Outcome:

6-minute walk test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超敏CRP

指标类型:

次要指标 

Outcome:

Hypersensitivity CRP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

blood routine tests

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

次要指标 

Outcome:

Liver function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

次要指标 

Outcome:

Renal function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

次要指标 

Outcome:

electrocardiogram

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

电解质

指标类型:

次要指标 

Outcome:

electrolyte

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌钙蛋白

指标类型:

次要指标 

Outcome:

TNI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

次要指标 

Outcome:

blood lipids

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量调查

指标类型:

次要指标 

Outcome:

Quality of life 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:

药物依从性调查

指标类型:

次要指标 

Outcome:

Medication adherence 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:

血糖

指标类型:

次要指标 

Outcome:

blood glucose

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:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 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):

设专人采用随机数字表随机

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

Designated persons using a random number table random

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

Data management Institution:

资料分析单位:

Data analysis Institution:

注册人:

Name on Registration:

 2013-05-07