今天是:2020-07-07 星期二

新型冠状病毒(COVID-19)肺炎中医证候流行病学研究
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注册号:

Registration number:

ChiCTR2000029430 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒(COVID-19)肺炎中医证候流行病学研究 

Public title:

Study for the TCM syndrome characteristics of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎(COVID-19)中医证候流行病学研究 

Scientific title:

An epidemiology study for TCM syndrome of novel coronavirus pneumonia (COVID-19) 

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:

ChiMCTR2000002947 

申请注册联系人:

张俊华 

研究负责人:

张忠德, 张伯礼 

Applicant:

ZHANG JUNHUA 

Study leader:

ZHANG ZHONGDE, ZHANG BOLI 

申请注册联系人电话:

Applicant telephone:

+86 13902020873 

研究负责人电话:

Study leader's telephone:

+86 13902020873 

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:

ZJHTCM@FOXMAIL.COM 

研究负责人电子邮件:

Study leader's E-mail:

ZJHTCM@FOXMAIL.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:

天津市静海区鄱阳湖路10号 

研究负责人通讯地址:

天津市静海区鄱阳湖路10号 

Applicant address:

10 Poyang Lake Road, Jinghai District, Tianjin, China 

Study leader's address:

10 Poyang Lake Road, Jinghai District, Tianjin, China 

申请注册联系人邮政编码:

Applicant postcode:

301617 

研究负责人邮政编码:

Study leader's postcode:

301617 

申请人所在单位:

天津中医药大学 

Applicant's institution:

Tianjin University 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:

[2020]004 

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:

湖北省中西医结合医院临床试验伦理委员会 

Name of the ethic committee:

Clinical trial ethics committee of Hubei integrated hospital of traditional Chinese and Western Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-31 

伦理委员会联系人:

夏文广 

Contact Name of the ethic committee:

XIA WENGUANG 

伦理委员会联系地址:

武汉市江汉区菱角湖路11号湖北省中西医结合医院 

Contact Address of the ethic committee:

Hubei Integrated Hospital of Traditional Chinese and Western Medicine, 11 Ling-Jiao-Hu Road, Jianghan District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-65600806 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

docxwg@163.com 

研究实施负责(组长)单位:

湖北省中西医结合医院 

Primary sponsor:

Hubei Integrated Hospital of Traditional Chinese and Western Medicine 

研究实施负责(组长)单位地址:

武汉市江汉区菱角湖路11号 

Primary sponsor's address:

11 Ling-Jiao-Hu Road, Jianghan District, Wuhan, Hubei, 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):

天津

市(区县):

天津市

Country:

China

Province:

Tianjin

City:

Tianjin

单位(医院):

天津中医药大学

具体地址:

天津市静海区鄱阳湖路10号

Institution
hospital:

Tianjin University of Traditional Chinese Medicine

Address:

10 Poyang Lake Road, Jinghai District

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):

广东省中医院

具体地址:

广州市大德路111号

Institution
hospital:

Guangdong Hospital of traditional Chinese Medicine

Address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

国家科技部 

Source(s) of funding:

MOST 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

novel coronavirus pneumonia (COVID-19) 

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:

调查新冠状病毒感染的患者中医证候特征 

Objectives of Study:

Investigative survey on TCM syndrome characteristics of patients with new coronavirus infection 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

确诊的2019-nCoV感染的肺炎患者为研究对象 

Inclusion criteria

Patients with Confirmed 2019-nCoV infected pneumonia 

排除标准:

NA 

Exclusion criteria:

NA 

研究实施时间:

Study execute time:

From2020-02-02To 2020-12-01 

干预措施:

Interventions:

组别:

观察组

样本量:

600

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北省中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Hubei integrated hospital of traditional Chinese and Western Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

中医证候

指标类型:

主要指标 

Outcome:

TCM syndroms

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:

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 90 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

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):

纸质报告

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

paper

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:

问卷调查表

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

CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-02-01
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