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3000例“病证结合”自然人群队列研究
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注册号:

Registration number:

ChiCTR2000039642 

最近更新日期:

Date of Last Refreshed on:

2020-11-04 

注册时间:

Date of Registration:

2020-11-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

3000例“病证结合”自然人群队列研究 

Public title:

Study on a natural population cohort of 3000 patients with combined disease and syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

3000例“病证结合”自然人群队列研究 

Scientific title:

Study on a natural population cohort of 3000 patients with combined disease and syndrome 

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:

吴琪 

研究负责人:

赵宗江 

Applicant:

Wu Qi 

Study leader:

Zong-jiang zhao 

申请注册联系人电话:

Applicant telephone:

18810627781 

研究负责人电话:

Study leader's telephone:

13910507288 

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:

1937743937@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zongjiangz@sina.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:

北京市朝阳区北三环东路11号 

研究负责人通讯地址:

北京市朝阳区北三环东路11号 

Applicant address:

No. 11 North 3rd Ring East Road, Chaoyang District, Beijing, China 

Study leader's address:

No. 11 North 3rd Ring East Road, Chaoyang District, Beijing, 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:

北京中医药大学 

Applicant's institution:

Beijing University of 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:

2020BZYLL0513 

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:

北京中医药大学医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing University of Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-10-21 

伦理委员会联系人:

秦灵灵 

Contact Name of the ethic committee:

Ling ling Qin 

伦理委员会联系地址:

北京市朝阳区北三环东路11号 

Contact Address of the ethic committee:

No. 11 North 3rd Ring East Road, Chaoyang District, Beijing, 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:

北京中医药大学 

Primary sponsor:

Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

北京市朝阳区北三环东路11号 

Primary sponsor's address:

No. 11 North 3rd Ring East Road, Chaoyang District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学

具体地址:

北京市朝阳区北三环东路11号

Institution
hospital:

Beijing University of Chinese Medicine

Address:

No. 11 North 3rd Ring East Road, Chaoyang District, Beijing, China

经费或物资来源:

国家科学与技术部重点研发计划资助项目子课题(2018YFC1704304) 

Source(s) of funding:

Sub-project of the Key Research and development Program funded by the Ministry of Science and Technology(2018YFC1704304) 

研究疾病:

慢性肾脏病 

Target disease:

chronic Kidney diseases  

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

通过自然人群队列建设可以探索“肾阳虚证”、“肾阳虚型慢性肾脏病”在人群中的分布情况等流行病学信息,发现“肾阳虚证”与“肾阳虚型慢性肾脏病”对于疾病,尤其是慢性肾脏病发病、证型转化及转归预后的影响,同时可观察和分析“肾阳虚证”、“肾阳虚型慢性肾脏病”发生发展的演变规律,也为慢性肾脏病“肾阳虚证”的核心病机、证候要素和演变规律提供指标量化标准,并为下一步临床实验提供数据资料,最终目的是为临床治疗及科研研究提供思路和依据,为人类健康事业奉献一份力量。 

Objectives of Study:

Through natural people queue construction can explore "the kidney Yang deficiency syndrome" and "kidney Yang deficiency type of chronic kidney disease (CKD)" in the crowd distribution and other epidemiological information, found that "the kidney Yang deficiency syndrome" and "kidney Yang deficiency type of chronic kidney disease (CKD)" for diseases, especially chronic kidney disease, syndrome type conversion, and the effect of prognosis of outcome, at the same time to observation and analysis of "the kidney Yang deficiency syndrome", "kidney Yang deficiency type of chronic kidney disease (CKD)" evolving law of development, also for chronic kidney disease (CKD) is the core of "kidney Yang deficiency syndrome" and pathogenesis, syndrome elements and evolution law provide index quantitative standard, and provide data for the next step in clinical trials,The ultimate goal is to provide ideas and basis for clinical treatment and scientific research, and to contribute to the cause of human health. 

药物成份或治疗方案详述:

无药物干预及治疗 

Description for medicine or protocol of treatment in detail:

This is an observational study that need not drug intervention  

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)自愿参与本队列研究试验,并签署知情同意书; (2)年龄35-80周岁; (3) 在当地居住1 年以上; 

Inclusion criteria

(1) Voluntarily participate in this cohort study and sign informed consent; (2) 35-80 years old; (3) Resided in the local area for more than 1 year; 

排除标准:

(1)患有严重传染性疾病、严重肢体残疾、精神疾患,或不能进行正常交流者; (2)近3个月内出现活动性消化道出血、严重血小板减少、凝血功能异常等血液系统疾病; (3)生命体征不稳,严重电解质紊乱; (4)妊娠期妇女、哺乳期妇女或近期有怀孕计划的女性; (5)近3个月内参加过或者正在参加其他临床试验; (6)研究者认为不适宜参加本队列研究。 

Exclusion criteria:

(1) persons suffering from serious infectious diseases, severe physical disabilities, mental disorders, or inability to communicate normally; (2) Active gastrointestinal bleeding, severe thrombocytopenia, abnormal coagulation function and other blood system diseases occurred in the past 3 months; (3) Unstable vital signs and severe electrolyte disturbance; (4) Pregnant women, lactating women or women with recent pregnancy plans; (5) Have participated in or are participating in other clinical trials within the last 3 months; (6) The researcher did not consider it appropriate to participate in this cohort study. 

研究实施时间:

Study execute time:

From2020-11-02To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-11-02To 2021-12-31 

干预措施:

Interventions:

组别:

无组别

样本量:

3000

Group:

no

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

王四营社区卫生服务中心 

单位级别:

一级 

Institution
hospital:

Wang Siying Community Health Service Center  

Level of the institution:

Level one 

测量指标:

Outcomes:

指标中文名:

血肌酐

指标类型:

主要指标 

Outcome:

serum creatinine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾小球滤过率

指标类型:

主要指标 

Outcome:

glomerular filtration rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血尿素氮

指标类型:

主要指标 

Outcome:

blood urea nitrogen

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血尿酸

指标类型:

主要指标 

Outcome:

blood uric acid

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:

标本中文名:

尿液

组织:

Sample Name:

urine

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 80 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):

并不涉及随机序列

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

It doesn't involve random sequences

盲法:

Blinding:

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):

论文发表

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

Papers published

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:

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, CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-11-04
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