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Traditional Chinese Medicine in the treatment of novel coronavirus pneumonia (COVID-19): a multicentre, randomized controlled trial
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注册号:

Registration number:

ChiCTR2000030034 

最近更新日期:

Date of Last Refreshed on:

2020-02-21 

注册时间:

Date of Registration:

2020-02-21 

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)的临床研究 

Public title:

Traditional Chinese Medicine in the treatment of novel coronavirus pneumonia (COVID-19): a multicentre, randomized controlled trial 

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的临床研究 

Scientific title:

Traditional Chinese Medicine in the treatment of novel coronavirus pneumonia (COVID-19): a multicentre, randomized controlled trial 

研究课题代号(代码):

Study subject ID:

浙江省科技计划项目(编号:2020C03127) 

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:

李亚平 

研究负责人:

柴可群 

Applicant:

Yaping Li 

Study leader:

Kequn Chai 

申请注册联系人电话:

Applicant telephone:

+86 13588417910 

研究负责人电话:

Study leader's telephone:

+86 13906503739 

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:

liyapin0186@vip.sina.com 

研究负责人电子邮件:

Study leader's E-mail:

ckqmzygzs@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:

浙江省杭州市古翠路234号 

研究负责人通讯地址:

浙江省杭州市古翠路234号 

Applicant address:

234 Gucui Road, Xihu District, Hangzhou, Zhejiang, China 

Study leader's address:

234 Gucui Road, Xihu District, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310012 

研究负责人邮政编码:

Study leader's postcode:

310012 

申请人所在单位:

浙江省立同德医院 

Applicant's institution:

Tongde Hospital of Zhejiang Province 

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:

浙同德伦理审字第【2020】001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:

浙江省立同德医院医学伦理委员会 

Name of the ethic committee:

Medical ethic committee of Tongde hospital of ZheJiang Province 

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:

王杨 

Contact Name of the ethic committee:

Wang Yang 

伦理委员会联系地址:

浙江省杭州市西湖区古翠路234号 

Contact Address of the ethic committee:

234 Gucui Road, Xihu District, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0571-89975971 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

tongdelunli@163.com 

研究实施负责(组长)单位:

浙江省立同德医院 

Primary sponsor:

Tongde Hospital of Zhejiang Province 

研究实施负责(组长)单位地址:

浙江省杭州市古翠路234号 

Primary sponsor's address:

234 Gucui Road, Xihu District, 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):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江省立同德医院

具体地址:

浙江省杭州市古翠路234号

Institution
hospital:

Tongde Hospital of Zhejiang Province

Address:

234 Gucui Road, Xihu District

经费或物资来源:

浙江省科学技术厅 

Source(s) of funding:

Science Technology Department of Zhejiang Province  

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:

其它 

Study phase:

N/A 

研究目的:

(1)提供有效的新型冠状病毒肺炎中医药治疗方案 (2)总结新型冠状病毒肺炎中医证型特点 (3)提供中药抗新型冠状病毒肺炎的有效制剂 

Objectives of Study:

1. Provide effective traditional Chinese medicine treatment protocol for novel coronavirus pneumonia 2. Summarize the characteristics of the TCM syndromes of the novel coronavirus pneumonia 3. Provide effective TCM preparations against novel coronavirus pneumonia 

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《新型冠状病毒(2019-nCoV)感染的肺炎诊疗快速建议指南 (标准版)》和国家卫健委《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》诊断标准的患者。 (2)符合中医辨证分型标准的患者。 (3)年龄在 18~85岁之间。 (4)在试验开始之前,受试者或其法定代理人自愿签署经伦理委员会核准的知情同意书。 

Inclusion criteria

(1) Patients in accordance with the diagnostic criteria of "Quick reference guide for diagnosis and treatment of novel coronavirus pneumonia(2019-nCoV)(Standard Edition)" and "Diagnostic and treatment protocols of novel coronavirus pneumonia(Trial version 5)" issued by National Health Commission; (2) Patients in accordance with the TCM syndrome differentiation standard; (3) Aged 18 to 85 years; (4) Before the trial begins, patients or their legal representatives voluntarily agree to participate by giving written informed consent approved by ethic committee.  

排除标准:

(1)确诊为流感病毒、副流感病毒、腺病毒、呼吸道合胞病毒、鼻病毒、人偏肺病毒、SARS冠状病毒等其他已知病毒性肺炎。 (2)确诊为支原体肺炎、衣原体肺炎及细菌性肺炎。 (3)确诊为血管炎、皮肌炎和机化性肺炎等非感染性疾病。 (4)年龄在18岁以下或85岁以上者,或妊娠期、哺乳期妇女。 (5)已知对本药组成成份过敏者。 (6)具有严重的基础疾病,且研究者认为其不宜入组的患者。 

Exclusion criteria:

(1) Diagnosed with other known viral pneumonia,like influenza virus, parainfluenza virus, adenovirus, respiratory syncytical virus, rhinovirus, human metapneumovirus and SARS coronavirus, etc.; (2) Diagnosed with mycoplasma pneumonia, chlamydial pneumonia and bacterial pneumonia; (3) Diagnosed with vasculitis, dermatomyositis, organizing pneumonia and other noninfectious diseases; (4) pregnant or breastfeeding woman; (5) Known to be allergic to this medicine ingredient; (6) Patients with serious underlying disease, and researchers considered inappropriate to participate. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

88

Group:

Experimental group

Sample size:

干预措施:

中药+西医常规治疗

干预措施代码:

Intervention:

TCM+Routine treatment of Western Medicine

Intervention code:

组别:

对照组

样本量:

44

Group:

Control group

Sample size:

干预措施:

西医常规治疗

干预措施代码:

Intervention:

Routine treatment of Western Medicine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang province 

City:

 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The first affiliated hospital of wenzhou medical university  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang Province 

City:

 

单位(医院):

温州市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Wenzhou central hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温岭市第一人民医院 

单位级别:

三乙医院 

Institution
hospital:

The first people's hospital of Wenling  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

绍兴市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shaoxing people's hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

丽水市中医院 

单位级别:

三甲医院 

Institution
hospital:

Lishui zhongyi yiyuan  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

衢州市人民医院 

单位级别:

三甲医院 

Institution
hospital:

People's hospital of Quzhou  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

瑞安市人民医院 

单位级别:

三乙医院 

Institution
hospital:

Ruian people's hospital  

Level of the institution:

Tertiary B Hospital 

测量指标:

Outcomes:

指标中文名:

体温

指标类型:

主要指标 

Outcome:

Body temperature

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候学积分

指标类型:

主要指标 

Outcome:

TCM syndrome integral

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Murray肺损伤评分

指标类型:

主要指标 

Outcome:

Murray lung injury score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新型冠状病毒核酸检测转阴时间

指标类型:

主要指标 

Outcome:

The transition time of novel coronavirus nucleic acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MuLBSTA评分

指标类型:

主要指标 

Outcome:

MuLBSTA score

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:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

标本中文名:

痰液

组织:

Sample Name:

sputum

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 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):

由项目人员万燕丽通过SPSS软件产生随机序列

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

Using SPSS to generate random sequences,completed by team member Yanli Wan.

盲法:

Not stated

Blinding:

Not stated

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):

临床试验公共管理平台http://www.medresman.org.cn/login.aspx

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

ResMan http://www.medresman.org.cn/login.aspx

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:

CRF和ResMan

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

CRF and ResMan

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-21
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