Today is 2020-07-05

Study for Traditional Chinese Medicine in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000033320 

最近更新日期:

Date of Last Refreshed on:

2020-05-28 

注册时间:

Date of Registration:

2020-05-27 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

中医药治疗新型冠状病毒肺炎(COVID-19)的临床研究 

Public title:

Study for Traditional Chinese Medicine in the 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:

中医药治疗新型冠状病毒肺炎(COVID-19)的临床研究 

Scientific title:

Study for Traditional Chinese Medicine in the 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:

ChiMCTR2000003347 

申请注册联系人:

张炜 

研究负责人:

张炜 

Applicant:

Zhang Wei 

Study leader:

Zhang Wei 

申请注册联系人电话:

Applicant telephone:

+86 13601733045 

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:

zhangw1190a@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangw1190a@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:

上海市浦东新区张衡路528号上海中医药大学附属曙光医院(东院)肺病科 

研究负责人通讯地址:

上海市浦东新区张衡路528号上海中医药大学附属曙光医院(东院)肺病科 

Applicant address:

528 Zhangheng Road, Pudong New District, Shanghai, China  

Study leader's address:

528 Zhangheng Road, Pudong New 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 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]YJ-2020-S065-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

上海市公卫临床中心医学伦理委员会 

Name of the ethic committee:

Shanghai Public Health Clinical Center Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

沈老师 

Contact Name of the ethic committee:

Mr. Shen 

伦理委员会联系地址:

上海市金山区漕廊公路2901号 

Contact Address of the ethic committee:

2901 Caolang Road, Jinshan 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:

上海中医药大学附属曙光医院 

Primary sponsor:

Department of Pulmonology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市浦东新区张衡路528号上海中医药大学附属曙光医院(东院)肺病科 

Primary sponsor's address:

528 Zhangheng Road, Pudong New 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:

上海市浦东新区张衡路528号上海中医药大学附属曙光医院(东院)肺病科

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address:

528 Zhangheng Road, Pudong New District

经费或物资来源:

上海市科学技术 

Source(s) of funding:

Shanghai Science and Technology Commission 

研究疾病:

新型冠状病毒肺炎 

Target disease:

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:

通过回顾性研究,定期对治疗方案进行评估、总结和优化,并及时为后续患者提供最优化的方案进行治疗工作。 

Objectives of Study:

Through retrospective research, the treatment plan is regularly evaluated, summarized, and optimized, and the most optimal plan is provided for subsequent patients in time for treatment. 

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. 符合西医新冠肺炎诊断标准; 2. 年龄18-65岁,男女不限; 

Inclusion criteria

1. Conform to the diagnostic criteria of Western Medicine's New Coronary Pneumonia; 2. Aged 18-65 years old male or female. 

排除标准:

1. 不符合新冠肺炎诊断标准者; 2. 妊娠或哺乳期妇女、对本药过敏者; 3. 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; 4. 含有影响疗效观察因素者; 5. 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. Those who do not meet the diagnostic criteria for new coronary pneumonia; 2. Women who are pregnant or breastfeeding, who are allergic to this medicine; 3. Combining patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, mental illness; 4. Contains factors that affect the observation of efficacy; 5. Those who do not meet the inclusion criteria, fail to use the prescribed drugs, and cannot determine the efficacy or incomplete data, etc., affect the efficacy or safety judgment. 

研究实施时间:

Study execute time:

From2020-03-27To 2020-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

150

Group:

Control

Sample size:

干预措施:

按照新型冠状病毒第七版诊疗方案的常规治疗

干预措施代码:

Intervention:

Guidelines for routine treatment

Intervention code:

组别:

治疗组

样本量:

150

Group:

Therapy group

Sample size:

干预措施:

TCM

干预措施代码:

Intervention:

TCM

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):

上海中医药大学附属曙光医院 

单位级别:

三甲医院 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

咽拭子核酸转阴时间

指标类型:

主要指标 

Outcome:

Throat Swab Nucleic Acid Test

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:

咽拭子

组织:

Sample Name:

Throat Swab

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 years
最大 Max age 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):

采用区组随机的方法,制定随机化方案。

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

Use the block random method to formulate a randomization plan.

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):

半年后公开

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

半年后公开

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:

半年后公开

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

半年后公开

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-27
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