Today is 2023-02-03

Black garlic improves heart failure of the patients with coronary heart disease by improving circulating antioxidant levels
download

注册号:

Registration number:

ChiCTR1800017999 

最近更新日期:

Date of Last Refreshed on:

2018-08-25 

注册时间:

Date of Registration:

2018-08-25 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

黑蒜通过改善循环抗氧化剂水平改善冠心病患者的心力衰竭 

Public title:

Black garlic improves heart failure of the patients with coronary heart disease by improving circulating antioxidant levels 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

黑蒜通过改善循环抗氧化剂水平改善冠心病患者的心力衰竭 

Scientific title:

Black garlic improves heart failure of the patients with coronary heart disease by improving circulating antioxidant levels 

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:

温澄飞 

研究负责人:

温澄飞 

Applicant:

Chengfei Wen 

Study leader:

Chengfei Wen 

申请注册联系人电话:

Applicant telephone:

+86 15143173560 

研究负责人电话:

Study leader's telephone:

+86 15143173560 

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:

wenchengfei00@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wenchengfei00@126.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:

中国吉林长春市朝阳区新民大街71号 

研究负责人通讯地址:

中国吉林长春市朝阳区新民大街71号 

Applicant address:

71 Xinmin Street, Changchun, Jilin, China 

Study leader's address:

71 Xinmin Street, Changchun, Jilin, 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:

吉林大学第一医院 

Applicant's institution:

The First Hospital of Jilin 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:

2016JLUXYD 

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:

吉林大学第一医院 伦理委员会 

Name of the ethic committee:

the human research ethical committee of First Hospital of Jilin University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-07-13 

伦理委员会联系人:

吉林大学第一医院 

Contact Name of the ethic committee:

First Hospital of Jilin University 

伦理委员会联系地址:

中国吉林长春市朝阳区新民大街71号 

Contact Address of the ethic committee:

71 Xinmin Street, Changchun, Jilin, China 

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:

吉林大学第一医院 

Primary sponsor:

First Hospital of Jilin University 

研究实施负责(组长)单位地址:

中国吉林长春市朝阳区新民大街71号 

Primary sponsor's address:

71 Xinmin Street, Changchun, Jilin, 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):

吉林省

市(区县):

Country:

China

Province:

Jilin

City:

单位(医院):

吉林大学第一医院

具体地址:

长春市朝阳区新民大街71号

Institution
hospital:

The First Hospital of Jilin University

Address:

71 Xinmin Street, Changchun, Jilin, China

经费或物资来源:

吉林大学第一医院创新基金 

Source(s) of funding:

Creative Funding committee of Jinlin University 

研究疾病:

心衰竭 

Target disease:

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:

我们旨在探讨黑蒜对冠心病(CHD)患者慢性心力衰竭(CHF)的临床疗效。 

Objectives of Study:

We aimed to explore the clinical effects of black garlic on chronic heart failure (CHF) of the patients with coronary heart disease (CHD). 

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:

同时Framingham的心力衰竭定性诊断标准和波士顿心力衰竭的定量诊断标准; 年龄35至75岁; 左心室射血分数(EF)≤50; 心功能等级II-III。 

Inclusion criteria

At the same time Framingham's heart failure qualitative diagnostic criteria and Boston heart failure quantitative diagnostic criteria; age 35 to 75 years; left ventricular ejection fraction (EF) ≤50; heart function grades II-III. 

排除标准:

如果参与者在过去3个月内有膝关节手术病史,全身性关节炎病症以及影响下肢功能的任何其他肌肉,关节或神经系统疾病,将被排除在外。 患者有急性冠状动脉综合征,严重的心脏瓣膜病,联合休克,计划的心外科手术,合并肝肾和其他全身性疾病。 

Exclusion criteria:

The participants would be excluded if they had a history of knee surgery within past 3 months, a systemic arthritic condition, and any other muscular, joint or neurological condition affecting lower limb function. The patients had acute coronary syndrome, severe valvular heart disease, combined shock, planned extracardiac surgery, combined hepatorenal and other systemic diseases. 

研究实施时间:

Study execute time:

From2017-02-23To 2018-01-01 

征募观察对象时间:

Recruiting time:

From2017-02-23To 2018-01-01 

干预措施:

Interventions:

组别:

黑蒜组和对照组

样本量:

120

Group:

black garlic and placebo groups

Sample size:

干预措施:

黑蒜vs安慰剂

干预措施代码:

Intervention:

black garlic versus placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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):

吉林大学第一医院 

单位级别:

三甲 

Institution
hospital:

The First Hospital of Jilin University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

生活质量

指标类型:

主要指标 

Outcome:

quality of life

Type:

Primary 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:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

刘景博通过电脑随机产生编号

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

The number was generated by Jingbo Liu via a computer

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

2018年6月6日实验室保存

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

06/06/2018 please contact PI

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:

一为病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-08-25
return list