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谷红注射液治疗微冠状动脉微血管功能障碍的临床研究
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注册号:

Registration number:

ChiCTR1900022902 

最近更新日期:

Date of Last Refreshed on:

2019-04-30 

注册时间:

Date of Registration:

2019-04-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

谷红注射液治疗微冠状动脉微血管功能障碍的临床研究 

Public title:

A randomized ctontrolled study for Guhong injection in the treatment of microcoronary microvascular dysfunction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

谷红注射液治疗微冠状动脉微血管功能障碍的临床研究 

Scientific title:

A randomized ctontrolled study for Guhong injection in the treatment of microcoronary microvascular dysfunction 

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:

蔡海荣 

研究负责人:

陈伯钧 

Applicant:

Cai Hairong 

Study leader:

Chen Bojun 

申请注册联系人电话:

Applicant telephone:

+86 17817399856 

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:

286941768@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

13902299108@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:

广州市番禺区大学城内环西路55号 

研究负责人通讯地址:

广州市番禺区大学城内环西路55号 

Applicant address:

55 Inner Ring Road West, University Town, Panyu District, Guangzhou 

Study leader's address:

55 Inner Ring Road West, University Town, Panyu District, Guangzhou 

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:

广州中医药大学第二附属医院(广东省中医院) 

Applicant's institution:

The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine (Guangdong Provincial Hospital 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:

广东省中医院伦理委员会BF2018-180-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

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:

Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-19 

伦理委员会联系人:

李晓彦 

Contact Name of the ethic committee:

Li Xiaoyan 

伦理委员会联系地址:

广州市越秀区大德路111号 

Contact Address of the ethic committee:

111 Dade Road, Yuexiu District, Guangzhou 

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:

广州中医药大学第二附属医院(广东省中医院) 

Primary sponsor:

The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine) 

研究实施负责(组长)单位地址:

广州市越秀区大德路111号 

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou 

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

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第二附属医院(广东省中医院)

具体地址:

越秀区大德路111号

Institution
hospital:

The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine)

Address:

111 Dade Road, Yuexiu District

经费或物资来源:

通化谷红制药有限公司 

Source(s) of funding:

Tonghua Guhong Pharmaceutical Co., Ltd. 

研究疾病:

冠状动脉微血管功能障碍 

Target disease:

Coronary microvascular dysfunction 

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:

上市后药物 

Study phase:

研究目的:

1.拟证实谷红注射液具有改善冠状动脉微血管功能障碍临床症状及中医证候评分的作用。 2.拟从炎症反应角度分析谷红注射液保护改善冠状动脉微血管功能在障碍的作用机制。 

Objectives of Study:

1. It is proposed to confirm that Guhong injection can improve the clinical symptoms of coronary microvascular dysfunction and the score of TCM syndrome. 2. To analyze the mechanism of Gu Hong injection protection to improve the function of coronary microvascular function in the inflammatory response. 

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. 冠状动脉造影或冠状动脉CT提示不存在不稳定冠状动脉粥样斑块或冠状动脉狭窄≤50%,同时伴有稳定型心绞痛临床症状的患者; 2. 年龄在35岁以上,75岁以下,性别不限; 3. 患者同意接受实验项目观察并签署同意书; 4. 依从性高,能合作观察不良事件和疗效。 

Inclusion criteria

1. Coronary angiography or coronary CT showed no unstable coronary atherosclerotic plaque or coronary artery stenosis ≤ 50%, accompanied by patients with stable angina clinical symptoms. 2. Aged over 35 years and under 75 years, gender is not limited; 3. The patient agrees to accept the observation of the experimental project and sign the consent form. 4. High compliance, can cooperate to observe adverse events and efficacy. 

排除标准:

1. 精神病患者;或妊娠妇女; 2. 合并心肌梗死或心衰患者; 3. 合并肝肾功能不全患者; 4. 合并脑卒中患者; 5. 合并动脉夹层或动脉栓塞患者; 6. 对谷红注射液过敏患者。 

Exclusion criteria:

1. A mentally ill person; or a pregnant woman; 2. Patients with myocardial infarction or heart failure; 3. Patients with liver and kidney dysfunction; 4. Combined stroke patients; 5. Patients with arterial dissection or arterial embolization; 6. Patients who are allergic to Guhong injection. 

研究实施时间:

Study execute time:

From2019-05-01To 2020-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

根据患者的基础病给予常规西医治疗

干预措施代码:

Intervention:

Conventional Western medicine treatment

Intervention code:

组别:

试验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

在患者常规西药治疗的基础上,加用谷红注射液静脉滴注治疗,一次20ml,用0.9%氯化钠注射液250ml稀释后应用,一日一次。

干预措施代码:

Intervention:

On the basis of the patient's routine western medicine treatment, intravenous infusion of Guhong injection was added, once 20ml, diluted with 0.9% sodium chloride injection 250ml, once a day.

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):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州中医药大学第二附属医院(广东省中医院) 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine)  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

临床疗效

指标类型:

主要指标 

Outcome:

Clinical efficacy

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:

心脏彩超

指标类型:

次要指标 

Outcome:

Echocardiography

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C-反应蛋白

指标类型:

次要指标 

Outcome:

C-reactive protein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-6

指标类型:

次要指标 

Outcome:

Interleukin-6

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 35 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):

随机数字表;赵帅

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

Random number table; Zhao Shuai

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

邮箱咨询

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

E-mail

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:

Excel,Word,CRF

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

Excel,Word,CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-30
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