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Clinical efficacy and endothelial function in acute coronary syndrome patients treated with Danhong Injection and Naoxintong capsule
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注册号:

Registration number:

ChiCTR-IOR-14005693 

最近更新日期:

Date of Last Refreshed on:

2014-12-20 

注册时间:

Date of Registration:

2014-11-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

丹红注射液联合脑心通胶囊对急性冠脉综合征的临床疗效及内皮功能的影响 

Public title:

Clinical efficacy and endothelial function in acute coronary syndrome patients treated with Danhong Injection and Naoxintong capsule 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

丹红注射液联合脑心通胶囊治疗急性冠脉综合征患者的临床疗效及内皮功能的随机对照、双盲研究 

Scientific title:

Clinical efficacy and endothelial function in acute coronary syndrome patients treated with Danhong Injection and Naoxintong capsule:a randomized double-blind controlled 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:

U1111-1163-8804 

申请注册联系人:

唐咏 

研究负责人:

陈伯钧 

Applicant:

Yong Tang 

Study leader:

Bojun Chen 

申请注册联系人电话:

Applicant telephone:

+86 13824483318 

研究负责人电话:

Study leader's telephone:

+86 13902299108 

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:

702058015@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

gzcbj@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:

中国广东省广州市荔湾区芳村金宇花园205号701房 

研究负责人通讯地址:

广东省中医院大学城分院急诊科办公室 

Applicant address:

Room 701, NO 205, Jinyun Garden, Fangcun, Liwan District, Guangzhou, Guangdong, China 

Study leader's address:

Supervisor's office of Emergency department, Second Affiliated Hospital of Guangzhou University of TCM, Guangzhou 510120, China. 

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:

广州中医药大学第三附属医院 

Applicant's institution:

Third Affliliated Hospital of Guangzhou tranditional chinese medicine university 

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:

B2014-031-02 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Institutional Ethics Committee of the Guangdong Provincial Hospital of Tranditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-09-05 

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:

广东省中医院 

Primary sponsor:

Guangdong Provincal Hospital of Traditional Chinese medicine 

研究实施负责(组长)单位地址:

广东省广州市番禺区大学城广东省中医院大学城分院急诊科 

Primary sponsor's address:

Emergency Department , Second Affiliated Hospital of Guangzhou University of TCM, Guangzhou 510120, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

广东省广州市番禺区大学城广东省中医院大学城分院

Institution
hospital:

Guangdong Provincial Hospital of TCM

Address:

Second Affiliated Hospital of Guangzhou University of TCM, Guangzhou 510120, China.

经费或物资来源:

步长制药集团科研基金 

Source(s) of funding:

the scientific research foundation of Buchang Pharmaceutical Group 

研究疾病:

急性冠脉综合征 

Target disease:

Acute Coronary Syndrome 

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:

其它 

Study phase:

N/A 

研究目的:

1、评测丹红注射液联合脑心通胶囊的临床疗效及对内皮功能的影响情况;2、探讨急性冠脉综合征患者的短期预后情况,观察丹红注射液联合脑心通胶囊能否降低心血管事件的发生。 

Objectives of Study:

1. Assess the clinical effects of Danhong injection combined with the Naoxintong capsules and their effects to the endothelial function as well; 2. Discuss the short-term prognosis of ACS (Acute Coronary Syndrome). Assess if the combined use of Danhong injection and Naoxintong capsules can reduce the incidence of cardiovascular 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:

1、符合西医急性冠脉综合征标准; 2、中医辩证为气虚痰瘀证者; 3、年龄在30-75岁,已签署知情同意书者。 

Inclusion criteria

1. Being in line with the Western standard of Acute Coronary Syndrome; 2. Fit with the TCM diagnosis of Qi deficiency and blood stasis and phlegm syndrome; 3. Patients who are aged between 30 to 75 yrs old, and have already signed the Consent form. 

排除标准:

1、脑心通胶囊、丹红注射液过敏者; 2、严重心律失常的患者如II度II型房室传导阻滞、病态窦房结综合症等以及严重的低血压、高血压急症、重度心衰(心功能III级以上,尚未有效控制)、急性心包填塞、急性肺水肿等。 3、合并出血性脑血管意外、消化道出血者;糖尿病并发症及严重肝肾功能损害者; 4、血友病、严重血小板减少、凝血功能异常者; 5、恶性肿瘤,精神病患者; 6、需要行冠脉旁路移植术(心脏搭桥术)患者。 

Exclusion criteria:

1. People who has an allergy to Danhong injection or Naoxintong capsule; 2. People who are severe arrhythmia, such as type II second degree atrioventricular block, sick sinus syndrome (SSS), etc. and severe hypotension or hypertension, severe heart failure (above heart function lever III, and not under control), acute cardiac tamponade, and acute pulmonary oedema, etc.; 3. People who have any medical conditions like merge hemorrhage cerebrovascular accident (CVA), gastrointestinal bleeding, Diabetes complications or severe liver and kidney problems; 4. People who have any medical condition like hemophilia, severe thrombocytopenia, or dysfunction of blood coagulation; 5. People with cancer or mental illness; 6. People who need the Coronary Artery Bypass Grafting (CABG). 

研究实施时间:

Study execute time:

From2014-09-01To 2016-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

200

Group:

The test group

Sample size:

干预措施:

丹红注射液联合脑心通胶囊+西医常规治疗

干预措施代码:

Intervention:

Danhong Injection and Naoxintong capsule, conventional treatment of western medicine

Intervention code:

组别:

对照组

样本量:

200

Group:

The control group

Sample size:

干预措施:

葡萄糖注射液联合脑心通胶囊安慰剂+西医常规治疗

干预措施代码:

Intervention:

Glucose Injection and placebo of Naoxintong capsule, conventional treatment of western medicine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三甲医院 

Institution
hospital:

Guangdong Provincal Hospital of Traditional Chinese medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

心血管事件的发生率

指标类型:

主要指标 

Outcome:

the incidence of cardiovascular events

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

内皮素

指标类型:

次要指标 

Outcome:

Endothelin, ET

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一氧化氮

指标类型:

次要指标 

Outcome:

Nitric oxide, NO

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管性血友病因子

指标类型:

次要指标 

Outcome:

von Willebrand factor, vWF

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血流介导的血管扩张功能

指标类型:

次要指标 

Outcome:

flow mediated dilation, FMD

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:

血管

Sample Name:

Blood

Tissue:

blood vessel

人体标本去向

其它 

说明

Fate of sample:

Others 

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 30 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):

计算机软件产生随机数字表

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

Computer software for generating random number table

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):

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-11-12
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