今天是:2019-06-18 星期二

尿酸昼夜波动节律及其影响因素研究
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注册号:

Registration number:

ChiCTR1900021200 

最近更新日期:

Date of Last Refreshed on:

2019-02-01 

注册时间:

Date of Registration:

2019-02-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

尿酸昼夜波动节律及其影响因素研究 

Public title:

Uric acid circadian rhythm and its influencing factors 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

尿酸昼夜波动节律及其影响因素研究 

Scientific title:

Uric acid circadian rhythm and its influencing factors 

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:

陈思 

研究负责人:

陈海冰 

Applicant:

CHEN SI 

Study leader:

CHEN HAIBING 

申请注册联系人电话:

Applicant telephone:

+86 15618949980 

研究负责人电话:

Study leader's telephone:

+86 18930173813 

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:

179503231@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

18930173813@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:

上海市徐汇区宜山路600号 

研究负责人通讯地址:

上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Shanghai, China 

Study leader's address:

600 Yishan Road, Shanghai, 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:

上海交通大学附属上海市第六人民医院 

Applicant's institution:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital  

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:

2018-102 

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:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Sixth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-04 

伦理委员会联系人:

贾伟平 

Contact Name of the ethic committee:

JIAWEIPING 

伦理委员会联系地址:

上海市宜山路600号上海市第六人民医院伦理委员会 

Contact Address of the ethic committee:

Ethics Committee, Shanghai Sixth People's Hospital, 600 Yishan Road, Shanghai, 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:

上海交通大学附属上海市第六人民医院 

Primary sponsor:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital  

研究实施负责(组长)单位地址:

上海市宜山路600号 

Primary sponsor's address:

600 Yishan Road, Shanghai, 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):

上海

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海交通大学附属上海市第六人民医院

具体地址:

上海市宜山路600号

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Address:

600 Yishan Road, Shanghai, China

经费或物资来源:

研究者科研经费 

Source(s) of funding:

Research funds of investigator 

研究疾病:

高尿酸血症 

Target disease:

Hyperuricemia 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

确定血尿酸昼夜波动节律及其影响因素 

Objectives of Study:

Clarify the uric acid circadian rhythm and its influencing factors 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

18周岁至70周岁;排除存在影响血尿酸检测的可能因素者 

Inclusion criteria

18 to 70 years old;Exclude the possible factors that affect the detection of blood uric acid 

排除标准:

排除任何可以影响血尿酸检测的疾病 

Exclusion criteria:

Exclude any disease that can affect blood uric acid testing 

研究实施时间:

Study execute time:

From2019-04-01To 2020-04-01 

干预措施:

Interventions:

组别:

对照组

样本量:

10

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

高尿酸血症组

样本量:

10

Group:

group of hyperuricemia

Sample size:

干预措施:

干预措施代码:

Intervention:

none

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 

市(区县):

上海市 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海交通大学附属上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People’s Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

甲状腺功能

指标类型:

次要指标 

Outcome:

Thyroid 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:

血液生化检查

指标类型:

主要指标 

Outcome:

Blood biochemical tests

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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):

2020年4月,百度网盘,http://pan.baidu.com/disk/home?errno=0&errmsg=Auth%20Login%20Sucess&&bduss=&ssnerror=0#list/path=%2F&vmode=list

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

April 2020, Baidu SkyDrive , http://pan.baidu.com/disk/home?errno=0&errmsg=Auth%20Login%20Sucess&&bduss=&ssnerror=0#list/path=%2F&vmode=list

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

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

excel

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-02-01
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