今天是:2020-07-07 星期二

中西医协同防治新型冠状病毒肺炎(COVID-19)的临床研究
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注册号:

Registration number:

ChiCTR2000029778 

最近更新日期:

Date of Last Refreshed on:

2020-02-13 

注册时间:

Date of Registration:

2020-02-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中西医协同防治新型冠状病毒肺炎(COVID-19)的临床研究 

Public title:

Clinical Study for Traditional Chinese Medicine Combined With Western Medicine in Treatment 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:

中西医协同防治新型冠状病毒肺炎(COVID-19)的临床研究 

Scientific title:

Clinical Study for Traditional Chinese Medicine Combined With Western Medicine in Treatment 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:

ChiMCTR2000003003 

申请注册联系人:

陈旋 

研究负责人:

张炜 

Applicant:

Xuan Chen 

Study leader:

Wei Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13611899735 

研究负责人电话:

Study leader's telephone:

+86 13601733045 

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:

chen77xuan@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangw1190@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:

上海浦东新区张衡路528号曙光医院5A病区呼吸科 

研究负责人通讯地址:

上海浦东新区张衡路528号曙光医院5A病区呼吸科 

Applicant address:

Pulmonary Department, 5A Ward, 528 Zhanghen Road, Pudong New Area District, Shanghai, China 

Study leader's address:

Pulmonary Department, 5A Ward, 528 Zhanghen Road, Pudong New Area District, 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:

上海中医药大学附属曙光医院 

Applicant's institution:

Shuguang Hospital Affiliated to Shanghai University of TCM. 

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:

20207940101 

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:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

IRB of Shuguang Hospital affiliated to Shanghai University of TCM. 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-12 

伦理委员会联系人:

耿希 

Contact Name of the ethic committee:

Geng Xi 

伦理委员会联系地址:

上海浦东新区张衡路528号曙光医院行政2F 

Contact Address of the ethic committee:

2nd Floor, Administrative District, 528 Zhanghen Road, Pudong New Area District, 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:

上海中医药大学 

Primary sponsor:

Shanghai University of TCM 

研究实施负责(组长)单位地址:

上海浦东新区张衡路528号 

Primary sponsor's address:

528 Zhanghen Road, Pudong New Area District, 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):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

具体地址:

浦东新区张衡路528号

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Shuguang Hospital Affiliated to Shanghai University of TCM.

Address:

528 Zhanghen Road, Pudong New Area District

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海公共卫生中心

具体地址:

金山区漕廊公路2901号

Institution
hospital:

Shanghai Public Health Clinic Center

Address:

2901 Caolang Road, Jinshan District

经费或物资来源:

上海中医药大学 

Source(s) of funding:

Shanghai University of TCM 

研究疾病:

新型冠状病毒肺炎 

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:

评估中西医协同防治新型冠状病毒肺炎的临床疗效。 

Objectives of Study:

To evaluate the efficacy and safety of Traditional Chinese Medicine combined with western medicine in Treatment of Novel Coronavirus Pneumonia (COVID-19). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

符合西医新冠肺炎诊断标准。 

Inclusion criteria

Meet the diagnostic criteria of Novel Coronavirus Pneumonia (COVID-19). 

排除标准:

1. 妊娠或哺乳期妇女、对本药过敏者; 2. 合并有心血管、肝、肾和造血系统等严重原发性疾病、精神病患者; 3. 含有影响疗效观察因素者; 4. 凡不符合纳入标准,未按规定用药,无法判定疗效或资料不全等影响疗效或安全性判断者。 

Exclusion criteria:

1. Pregnant or lactating women, allergic to the research drug; 2. Combined with cardiovascular, liver, kidney and hematopoietic systems and other serious primary diseases, mental illness; 3. Those with observational factors affecting efficacy; 4. Those who do not meet the inclusion criteria, do not use the prescribed drugs, can not determine the efficacy or incomplete information and other effects of efficacy or safety judgment. 

研究实施时间:

Study execute time:

From2020-02-14To 2020-05-13 

干预措施:

Interventions:

组别:

中西医协同组

样本量:

150

Group:

TCM Group

Sample size:

干预措施:

中药辨证论治+常规治疗

干预措施代码:

Intervention:

herbal medicine and conventional treatment

Intervention code:

组别:

清肺排毒汤组

样本量:

150

Group:

QFPD decoction group

Sample size:

干预措施:

清肺排毒汤+常规治疗

干预措施代码:

Intervention:

QFPD decoction and conventional treatment

Intervention code:

组别:

疏风解毒组

样本量:

150

Group:

SFJD capsuale group

Sample size:

干预措施:

疏风解毒胶囊+常规治疗

干预措施代码:

Intervention:

SFJD capsuale and conventional treatment

Intervention code:

组别:

对照组

样本量:

150

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional treatment

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(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海公共卫生中心 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Public Health Clinic Center  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

Length of hospital stay

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

退热时间

指标类型:

主要指标 

Outcome:

fever clearance time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医病证疗效

指标类型:

次要指标 

Outcome:

Effective rate of TCM symptoms

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

解热时间

指标类型:

次要指标 

Outcome:

antipyretic time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咽拭子核酸转阴时间

指标类型:

次要指标 

Outcome:

clearance time of COVID-19 in Nasopharyngeal swabs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CT影像学指标

指标类型:

次要指标 

Outcome:

CT scan

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血液炎症指标

指标类型:

次要指标 

Outcome:

inflammatory cytokines in blood serum

Type:

Secondary 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 sample

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:

标本中文名:

咽拭子

组织:

Sample Name:

Nasopharyngeal swabs

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 15 years
最大 Max age 85 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):

非随机对照试验。

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

Non-randomization

盲法:

未说明

Blinding:

Not stated

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):

Publication of 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:

病例记录表

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:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-13
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