今天是:2020-07-07 星期二

中西医结合治疗普通型新型冠状病毒肺炎(COVID-19)临床试验
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注册号:

Registration number:

ChiCTR2000029439 

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:

中西医结合治疗普通型新型冠状病毒肺炎(COVID-19)临床试验 

Public title:

Combination of traditional Chinese medicine and western medicine in the treatment of common type novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中西医结合治疗普通型新型冠状病毒肺炎(COVID-19)的临床试验 

Scientific title:

Combination of traditional chinese medicne and western medicine in the treatment of common type 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:

ChiMCTR2000002955 

申请注册联系人:

张俊华 

研究负责人:

王玉光;李旭成;张伯礼 

Applicant:

ZHANG JUNHUA 

Study leader:

WANG YUGUANG, LI XUCHENG, 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:

北京市东城区美术馆后街23号 

Applicant address:

10 Poyang Lake Road, West Zone, Tuanbo New City, Jinghai District, Tianjin, China 

Study leader's address:

23 Back Street of Art Gallery, Dongcheng District, Beijing/11 Lingjiao Lake Road, Jianghan 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:

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]002 

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 

Contact Address of the ethic committee:

11 Lingjiao Lake 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:

北京中医医院/湖北省中西医结合医院 

Primary sponsor:

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University/Beijing institute of Traditional Chinese MedHubei integrated traditional Chinese and Western Medicine Hospital 

研究实施负责(组长)单位地址:

北京市东城区美术馆后街23号 

Primary sponsor's address:

23 Back Street of Art Gallery, Dongcheng District, Beijing/11 Lingjiao Lake 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市中医医院

具体地址:

武汉市江汉区菱角湖路11号

Institution
hospital:

Wuhan traditional Chinese medicine hospital

Address:

11 Lingjiao Lake Road, Jianghan District

国家:

中国

省(直辖市):

北京

市(区县):

北京

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医医院

具体地址:

北京市东城区美术馆后街23号

Institution
hospital:

Beijing hospital of Traditional Chinese medicine

Address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, 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:

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:

评价中药标准汤剂联合西医疗法与单纯西医治疗对比,治疗新型冠状病毒感染的肺炎的疗效。 

Objectives of Study:

To assess the effect of TCM standard decoctions combined with western medicine, than only western medical support therapies for pneumonia (common type) caused by new coronavirus (2019-nCoV). 

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) 确诊为新型冠状病毒感染的肺炎患者; 2) 病情判断为普通型; 3) 患者知情同意。 

Inclusion criteria

1) patients diagnosed as Pneumonia caused by new coronavirus infection (2019-nCoV); 2) The classification was judged as common type; 3) Informed consent. 

排除标准:

1)影响生存的严重基础疾病; 2)孕妇或哺乳期妇女; 3)其他医生认为不符合参加研究的问题; 4)患者服用中药汤剂有困难。 

Exclusion criteria:

1) Pregnant or lactating women; 2) Severe basic diseases that affect survival; 3) Other problems thant doctor's judgment is not suitable for the study; 4) Patients have difficulty in taking TCM standard decoctions. 

研究实施时间:

Study execute time:

From2020-02-01To 2021-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

西医基础治疗

干预措施代码:

Intervention:

basic western medical therapies

Intervention code:

组别:

试验组

样本量:

60

Group:

experimental group

Sample size:

干预措施:

中药标准汤剂+西医治疗

干预措施代码:

Intervention:

TCM standard decoctions+basic western medical therapies

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 traditional Chinese and Western Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

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):

武汉市中医院 

单位级别:

三级 

Institution
hospital:

WUHAN HOSPITAL OF TCM  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

退热时间

指标类型:

主要指标 

Outcome:

Antipyretic 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:

病毒转阴时间

指标类型:

主要指标 

Outcome:

Time of virus turning negative

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺功能

指标类型:

次要指标 

Outcome:

Pulmonary 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:

重症转化率

指标类型:

次要指标 

Outcome:

conversion rate of severe cases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症指标

指标类型:

次要指标 

Outcome:

Inflammation index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

消化道症状消失时间

指标类型:

次要指标 

Outcome:

Disappearance time of gastrointestinal 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:

中医证候

指标类型:

次要指标 

Outcome:

Syndrome of traditional Chinese Medicine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

次要指标 

Outcome:

Adverse events

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:

组织:

Sample Name:

no

Tissue:

no

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 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):

天津中医药大学循证医学中心使用SAS软件产生随机号。

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

Evidence based medicine center at Tianjin University of traditional Chinese medicine will generates the random number,using SAS software.

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):

纸质申请

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

paper application.

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:

纸质crf和电子表格。

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

paper CRF AND EDC.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-01
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