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Randomized controlled trial for traditional Chinese medicine in the prevention of novel coronavirus pneumonia (COVID-19) in high risk population
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注册号:

Registration number:

ChiCTR2000029435 

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:

中医药预防新型冠状病毒肺炎(COVID-19)的随机对照试验 

Public title:

Randomized controlled trial for traditional Chinese medicine in the prevention of novel coronavirus pneumonia (COVID-19) in high risk population 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医药预防新型冠状病毒肺炎(COVID-19)的随机对照试验 

Scientific title:

Randomized controlled trial for traditional Chinese medicine in the prevention of novel coronavirus pneumonia (COVID-19) in high risk population 

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:

ChiMCTR2000002951 

申请注册联系人:

罗丹 

研究负责人:

魏力 

Applicant:

Luo Dan 

Study leader:

Wei Li 

申请注册联系人电话:

Applicant telephone:

+86 13163283819 

研究负责人电话:

Study leader's telephone:

+86 13163283819 

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:

1362205873@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

whsdyyykjc@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:

武汉市硚口区中山大道215号 

研究负责人通讯地址:

武汉市硚口区中山大道215号 

Applicant address:

215 Zhongshan Avenue, Qiaokou District, Wuhan, Hubei, China 

Study leader's address:

215 Zhongshan Avenue, Qiaokou District, Wuhan, Hubei, 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:

武汉市第一医院 

Applicant's institution:

Wuhan 1st 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:

武卫一院伦审[2020]1号 

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:

武汉市第一医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Wuhan 1st Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-01 

伦理委员会联系人:

王为民 

Contact Name of the ethic committee:

Wang Wei-Ming 

伦理委员会联系地址:

武汉市中山大道215号 

Contact Address of the ethic committee:

215 Zhongshan Avenue, Qiaokou District, Wuhan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 027-85332015 

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:

武汉市第一医院 

Primary sponsor:

Wuhan 1st Hospital 

研究实施负责(组长)单位地址:

武汉市第一医院 

Primary sponsor's address:

215 Zhongshan Avenue, Qiaokou 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):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市第一医院

具体地址:

武汉市硚口区中山大道215号

Institution
hospital:

Wuhan 1st Hospital

Address:

215 Zhongshan Avenue, Qiaokou District

经费或物资来源:

武汉市第一医院 

Source(s) of funding:

Wuhan 1st Hospital 

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:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

评估中医药对高危、疑似新冠状病毒肺炎人群进行预防的有效性和安全性 

Objectives of Study:

To assess the effect and safety of Traditional Chinese medicine in the prevention of high risk and suspected 2019-nCOV pneumonia. 

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:

1.18<年龄<60 2.14日明确有确诊人群暴露史 3.有发热,有血常规检查,有CT检查,其中三项满足两项阳性表现 

Inclusion criteria

1. aged 18 to 60 years 2. to be confirmed with a exposure history of diagnosed population within last 14 days; 3. with fever, positive results of blood routine examination and positive findings in CT examination, any two in three items met. 

排除标准:

1.妊娠期或哺乳期者 2.既往严重慢性基础疾病 3.既往中药过敏 4.已确诊新型冠状病毒肺炎者 

Exclusion criteria:

1. Pregnancy or lactation; 2. Previous serious chronic basic diseases; 3. Previous allergy to traditional Chinese medicine; 4. Newly diagnosed 2019-nCOV pneumonia. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-03-31 

干预措施:

Interventions:

组别:

社区暴露中药组

样本量:

20

Group:

Community exposure TCM intervention group

Sample size:

干预措施:

中药干预

干预措施代码:

Intervention:

TCM intervention

Intervention code:

组别:

社区暴露对照组

样本量:

20

Group:

Community exposure control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

医院暴露中药组

样本量:

20

Group:

Hospital exposure TCM intervention group

Sample size:

干预措施:

中药干预

干预措施代码:

Intervention:

TCM intervention

Intervention code:

组别:

医院暴露对照组

样本量:

20

Group:

Hospital exposure control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

社区疑似中药组

样本量:

20

Group:

Community suspected TCM intervention group

Sample size:

干预措施:

中药干预

干预措施代码:

Intervention:

TCM intervention

Intervention code:

组别:

社区疑似对照组

样本量:

20

Group:

Community suspected control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

医院疑似中药组

样本量:

20

Group:

Hospital suspected TCM intervention group

Sample size:

干预措施:

中药干预

干预措施代码:

Intervention:

TCM intervention

Intervention code:

组别:

医院疑似对照组

样本量:

20

Group:

Hospital suspected control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市第一医院 

单位级别:

三甲医院 

Institution
hospital:

Wuhan 1st Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

病毒核酸检测

指标类型:

主要指标 

Outcome:

Viral nucleic acid detection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部CT

指标类型:

主要指标 

Outcome:

CT Scan of the Lungs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Blood routine examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

次要指标 

Outcome:

Hepatorenal 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:

体温

指标类型:

主要指标 

Outcome:

Temperature

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

次要指标 

Outcome:

Heart rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

次要指标 

Outcome:

Blood pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

Height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Weight

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:

痰液

组织:

Sample Name:

sputum

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 60 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):

由第三方人员采取随机数表法进行随机分组

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

The random number table method was adopted by the third party for random grouping

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

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):

由武汉市第一医院官网公开数据 http://www.whyyy.com.cn/

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

The data is disclosed by the official website of wuhan first hospitalal http://www.whyyy.com.cn/

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:

由病例记录表进行试验记录,试验完成后生成电子数据

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

The test was recorded in CRF and electronic data was generated after the test was comple

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-01
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