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Chinese medicine prevention and treatment program for novel coronavirus pneumonia (COVID-19): a perspective, sing-arm trial
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注册号:

Registration number:

ChiCTR2000029578 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医防治新型冠状病毒肺炎(COVID-19)的单臂研究 

Public title:

Chinese medicine prevention and treatment program for novel coronavirus pneumonia (COVID-19): a perspective, sing-arm trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医分期方案防治新型冠状病毒肺炎(COVID-19)的RCT临床联合研究方案 

Scientific title:

Chinese medicine prevention and treatment program for 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:

 

申请注册联系人:

谢志军 

研究负责人:

温成平 

Applicant:

Zhijun Xie 

Study leader:

Chengping Wen 

申请注册联系人电话:

Applicant telephone:

+86 571 86613587 

研究负责人电话:

Study leader's telephone:

+86 571 86613587 

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:

xzj575@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wengcp@163.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:

浙江省杭州市滨文路548号 

研究负责人通讯地址:

浙江省杭州市滨文路548号 

Applicant address:

548 Binwen Road, Hangzhou, Zhejiang, China 

Study leader's address:

548 Binwen Road, Hangzhou, Zhejiang, 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:

浙江中医药大学 

Applicant's institution:

Zhejiang Chinese Medical University 

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年(科)伦审第15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:

杭州市西溪医院(杭州市第六人民医院)伦理委员 

Name of the ethic committee:

Medical Ethics Committee of Hangzhou Xixi Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-05 

伦理委员会联系人:

李兆翌 

Contact Name of the ethic committee:

Zhaoli LI 

伦理委员会联系地址:

中国浙江省杭州市西湖区留下镇横埠街2号 

Contact Address of the ethic committee:

2 Hengbu Street, Liuxia Town, Xihu District, Hangzhou, Zhejiang, 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:

浙江中医药大学 

Primary sponsor:

Zhejiang Chinese Medical University 

研究实施负责(组长)单位地址:

浙江省杭州市滨文路548号 

Primary sponsor's address:

548 Binwen Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江中医药大学

具体地址:

滨文路548号

Institution
hospital:

Zhejiang Chinese Medical University

Address:

548 Binwen Road

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

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:

明确中医药分期方案治疗2019新型冠状病毒(2019-nCoV)感染病例的治愈率、痊愈时间、减少重症、危重症发生率方面的疗效及安全性。 

Objectives of Study:

To identify the efficacy and safety of the Chinese medicine staging program in the cure rate, healing time, reduction of the incidence of severe and critical illness in 2019 new-type coronavirus (2019-nCoV) infection. 

药物成份或治疗方案详述:

西医治疗方案采用国家卫健委印发的“新型冠状病毒感染的肺炎诊疗方案”中的确诊病例轻型、普通型和重型的西药治疗方案治疗;中医采用“杭州市西溪医院新型冠状病毒感染的肺炎中医医疗救治方案”中的中医医学观察期、初期、中期和国家卫健委印发的“新型冠状病毒感染的肺炎诊疗方案”中恢复期的中医处方加减治疗结合西医治疗方案治疗。 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

① 符合“国家卫健委印发第五版新型冠状病毒感染的肺炎诊疗方案” (附件1)中的确诊病例轻型(医学观察期)、普通型(中医临床治疗初期)或重型(中医临床治疗中期)诊断标准的患者; ② 前瞻性研究的患者知情并同意参加本研究。 

Inclusion criteria

1. Patients who meet the diagnostic criteria of the fifth edition of pneumonia diagnosis and treatment plan for new coronavirus infection issued by the national health and health commission (annex 1) for the confirmed cases of light (medical observation period), common (early stage of TCM clinical treatment) or heavy (middle stage of TCM clinical treatment); 2. Prospective study patients informed and consented to participate in this study. 

排除标准:

有其他严重脏器病变者或精神类疾病者。 

Exclusion criteria:

Patients with other serious organ diseases or mental illness. 

研究实施时间:

Study execute time:

From2020-02-06To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2020-02-06To 2020-04-30 

干预措施:

Interventions:

组别:

中西医组

样本量:

1000

Group:

Treatment group

Sample size:

干预措施:

中西医结合治疗

干预措施代码:

Intervention:

Integrated Traditional Chinese and Western Medicine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市西溪医院 

单位级别:

三甲 

Institution
hospital:

Hangzhou Xixi hospital  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

治愈率

指标类型:

主要指标 

Outcome:

Cure rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治愈时间

指标类型:

主要指标 

Outcome:

The cure 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:

普通型进展为重型的比率及时间

指标类型:

主要指标 

Outcome:

The rate and time at which the normal type progresses to the heavy type

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重型进展为危重型甚至死亡的比率及时间

指标类型:

主要指标 

Outcome:

Rate and time of progression from heavy to critical type and even death

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状(发热、乏力、胃肠不适等)缓解情况及缓解时间

指标类型:

次要指标 

Outcome:

Clinical symptoms (fever, weakness, gastrointestinal discomfort, etc.) remission and remission 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:

肺HRCT评分改善情况

指标类型:

次要指标 

Outcome:

Improvement of lung HRCT score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候改善情况

指标类型:

次要指标 

Outcome:

Improvement of TCM syndromes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平均住院时间

指标类型:

次要指标 

Outcome:

Average length of hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生率

指标类型:

次要指标 

Outcome:

Incidence of 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:

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:

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:

粪便

组织:

Sample Name:

faeces

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:

throat swab

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:

下呼吸道分泌物

组织:

Sample Name:

Lower respiratory tract secretions

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):

单臂研究,非随机

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

single-arm study, non-randomization.

盲法:

N/A

Blinding:

N/A

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:

Real time access

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):

lcblcjsystem.zcmu.edu.cn

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

lcblcjsystem.zcmu.edu.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:

病例记录表和管理系统(

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

CRF and EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-05
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