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Clinical Controlled Trial for Traditional Chinese Medicine in the treatment of Novel Coronavirus Pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029400 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-01-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医药治疗新型冠状病毒肺炎(COVID-19)临床对照研究 

Public title:

Clinical Controlled Trial 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:

中医药防治新型冠状病毒肺炎(COVID-19)的研究 

Scientific title:

Study for Traditional Chinese Medicine in the Prevention and Treatment of Novel Coronavirus Pneumonia (COVID-19) 

研究课题代号(代码):

Study subject ID:

2020YFC0841500 

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:

ChiMCTR2000002940 

申请注册联系人:

赵晨 

研究负责人:

黄璐琦 

Applicant:

Zhao Chen 

Study leader:

Huang Luqi 

申请注册联系人电话:

Applicant telephone:

+86 010-64093295 

研究负责人电话:

Study leader's telephone:

+86 010-64089801 

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:

zyyzc2007@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huangluqi01@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:

北京市东城区东直门内南小街16号 

研究负责人通讯地址:

北京市东城区东直门内南小街16号 

Applicant address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, China 

Study leader's address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, 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:

中国中医科学院 

Applicant's institution:

China Academy of Chinese Medical Sciences 

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]No.1 

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:

中国中医科学院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-29 

伦理委员会联系人:

杨洪军 

Contact Name of the ethic committee:

Yang Hongjun 

伦理委员会联系地址:

北京市东城区东直门内南小街16号 

Contact Address of the ethic committee:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, 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:

中国中医科学院 

Primary sponsor:

China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市东城区东直门内南小街16号 

Primary sponsor's address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院

具体地址:

东城区东直门内南小街16号

Institution
hospital:

China Academy of Chinese Medical Sciences

Address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District

经费或物资来源:

国家重点研发计划(2020YFC0841500) 

Source(s) of funding:

National Key Research and Development Program Fund (No.2020YFC0841500) 

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:

评价中医药治疗方案对新型冠状病毒感染的肺炎的疗效。 

Objectives of Study:

To evaluate the efficacy of traditional Chinese medicine treatment on pneumonia caused by novel coronavirus infection. 

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:

1) 符合《新型冠状病毒感染的肺炎诊疗方案(试行第四版)》中新型冠状病毒感染的肺炎的诊断标准; 2) 同意参加研究,患者本人或法定监护人签署知情同意书。 

Inclusion criteria

1) Comply with the diagnostic criteria for pneumonia caused by novel coronavirus infection in the "Diagnosis and Treatment Program for pneumonia caused by novel coronavirus infection (Trial Version 4)"; 2) Agree to participate in the study and the patient or legal guardian signs the informed consent form. 

排除标准:

1) 危重症新型冠状病毒感染的肺炎患者。 2) 初始发病时间超过5天患者。 3) 合并严重原发性呼吸系统疾病患者。 4) 难以通过口服、鼻饲途径给药患者。 5) 孕产妇,患有恶性肿瘤、精神疾病等其他恶性疾病,以及各类研究者认为不适合参加研究的患者。 

Exclusion criteria:

1) Patients with particularly severe pneumonia caused by novel coronavirus infection. 2) Patients whose initial onset time exceeds 5 days. 3) Patients with severe primary respiratory disease. 4) It is difficult to administer to patients by oral or nasal feeding. 5) Pregnant women, as well as patients with other malignancies such as malignant tumors, mental illnesses, and patients who are not considered suitable for study. 

研究实施时间:

Study execute time:

From2020-01-29To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-01-29To 2020-06-30 

干预措施:

Interventions:

组别:

A组

样本量:

20

Group:

Group A

Sample size:

干预措施:

中医药治疗方案

干预措施代码:

Intervention:

traditional Chinese medicine treatment

Intervention code:

组别:

B组

样本量:

20

Group:

Group B

Sample size:

干预措施:

洛匹那韦/利托那韦

干预措施代码:

Intervention:

Lopinavir / Ritonavir

Intervention code:

组别:

C组

样本量:

20

Group:

Group C

Sample size:

干预措施:

中医药治疗方案+洛匹那韦/利托那韦

干预措施代码:

Intervention:

traditional Chinese medicine treatment and Lopinavir / Ritonavir

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):

武汉市金银潭医院 

单位级别:

三级甲等 

Institution
hospital:

Wuhan Jinyintan Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床缓解率

指标类型:

主要指标 

Outcome:

the rate of remission

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

转危重症率

指标类型:

次要指标 

Outcome:

the rate of critcal aggravation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

解除隔离率

指标类型:

次要指标 

Outcome:

the rate of disisolation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症状学积分

指标类型:

次要指标 

Outcome:

TCM symptom 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:

血氧饱和度

指标类型:

次要指标 

Outcome:

Blood oxygen saturation

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:

次要指标 

Outcome:

Body temperature

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规检查

指标类型:

次要指标 

Outcome:

blood routine test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血生化检查

指标类型:

次要指标 

Outcome:

Blood biochemical test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部影像学

指标类型:

次要指标 

Outcome:

Chest imaging

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:

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 18 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):

未使用

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

Not used

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

研究完成后,我们将发布研究报告。

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

After the research is completed, we will release a research report.

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:

中国中医科学院

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

China Academy of Chinese Medical Sciences

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-29
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