Today is 2020-02-29

A real world study for traditional Chinese Medicine in the treatment of novel coronavirus pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000029624 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-07 

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)真实世界临床观察研究 

Public title:

A real world 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)真实世界临床观察研究 

Scientific title:

A real world 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:

ChiMCTR2000002977 

申请注册联系人:

吕莹 

研究负责人:

卢洪洲 

Applicant:

Lyu Ying 

Study leader:

Lu Hongzhou 

申请注册联系人电话:

Applicant telephone:

+86 18916099680 

研究负责人电话:

Study leader's telephone:

+86 18930810088 

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:

lvying@shphc.org.cn 

研究负责人电子邮件:

Study leader's E-mail:

Luhongzhou@shphc.org.cn 

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:

上海市金山区漕廊公路2901号 

研究负责人通讯地址:

上海市金山区漕廊公路2901号 

Applicant address:

2901 Caolang Road, Jinshan District, Shanghai, China 

Study leader's address:

2901 Caolang Road, Jinshan 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:

上海市公共卫生临床中心 

Applicant's institution:

Shanghai Public Health Clinical Center 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海市公共卫生临床中心 

Primary sponsor:

Shanghai Public Health Clinical Center 

研究实施负责(组长)单位地址:

上海市金山区漕廊公路2901号 

Primary sponsor's address:

2901 Caolang Road, Jinshan 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

市(区县):

上海

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海市公共卫生临床中心

具体地址:

上海市金山区漕廊公路2901号

Institution
hospital:

Shanghai Public Health Clinical Center

Address:

2901 Caolang Road, Jinshan District

经费或物资来源:

上海市卫生健康委员会 

Source(s) of funding:

Shanghai Municipal Health Commission  

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:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

观察研究中医药辨治新型冠状病毒感染的肺炎的临床疗效,进一步明确新型冠状病毒感染的肺炎的中医病证特征,优化中医诊疗方案。 

Objectives of Study:

To observe and study the clinical effect of TCM in the treatment of pneumonia caused by 2019 novel coronavirus infection, to further clarify the TCM syndrome characteristics of pneumonia caused by 2019 novel coronavirus infection, and to optimize the TCM diagnosis and treatment program. 

药物成份或治疗方案详述:

连续入组 

Description for medicine or protocol of treatment in detail:

Sequential 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

疑似病例 符合国家卫生健康委员会制定的《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疑似病例诊断标准,根据上海市新型冠状病毒感染的肺炎疫情防控工作领导小组办公室制定的《上海市新型冠状病毒感染的肺炎中医诊疗方案(试行)》中医学观察期患者。 具有流行病学史中的任意一条,且符合临床表现的任意两条。 1流行病学史 (1)发病前14天内有武汉地区或其他有本地病例持续传播地区的旅行史或居住史; (2)发病前14天内曾接触过来自武汉市或其他有本地病例持续传播地区的发热或呼吸道症状的患者; (3)有聚集性发病或与新型冠状病毒感染者有流行病学关联。 2临床表现 (1)发热; (2)具有肺炎影像学特征:早期呈现多发小斑片影及间质改变,以肺外带明显。进而发展为双肺多发磨玻璃影、浸润影,严重者可出现肺实变,胸腔积液少见。 (3)发病早期白细胞总数正常或降低,或淋巴细胞计数减少。 确诊病例 疑似病例,具备以下病原学证据之一者: (1)呼吸道标本或血液标本实时荧光RT-PCR检测新型冠状病毒核酸阳性; (2)呼吸道标本或血液标本病毒基因测序,与已知的新型冠状病毒高度同源。 

Inclusion criteria

1. Suspected case: Patients in observation period of traditional Chinese medicine who are in line with the diagnostic criteria for suspected cases of pneumonia caused by 2019 novel coronavirus infection in the "diagnosis and treatment plan for pneumonia caused by 2019 novel coronavirus infection (trial version IV)", formulated by the National Health Commission, and in accordance with the "diagnosis and treatment plan for pneumonia caused by 2019 nove coronavirus infection in Shanghai (Trial Implementation)",formulated by the office of the leading group for the prevention and control of pneumonia caused by 2019 novel coronavirus infection in Shanghai,. Any one with epidemiological history and any two with clinical manifestations. (1) Epidemiological history 1) Within 14 days before the onset of the disease, there was a travel history or residential history in Wuhan or other areas where the local cases continued to spread; 2) Within 14 days before the onset of the disease, the patient had been exposed to fever or respiratory symptoms from Wuhan city or other areas where local cases continue to spread; 3) There is a clustering disease or an epidemiological association with the new coronavirus infection. (2) Clinical manifestations: 1) Fever; 2) It has the imaging characteristics of pneumonia: in the early stage, there are multiple small spot shadow and interstitial changes, especially in the extrapulmonary zone. In severe cases, lung consolidation and pleural effusion are rare; 3) In the early stage of the disease, the total number of leukocytes was normal or decreased, or the lymphocyte count was decreased. 

排除标准:

排除不符合参加临床研究的其他情况如精神异常、妊娠期或哺乳期妇女、有药物滥用或依赖史、对研究药物过敏、3个月内参加过其他临床研究等。 

Exclusion criteria:

Patients who have mental confusion, pregnant or lactating women, who with a history of drug abuse or dependence, who allergic to study medication, who have participated in another clinical trial within 3 months,or who have other conditions not suitable for clinical study.  

研究实施时间:

Study execute time:

From2020-02-08To 2021-02-07 

干预措施:

Interventions:

组别:

Case series

样本量:

500

Group:

Case series

Sample size:

干预措施:

中医药

干预措施代码:

Intervention:

Traditional Chinese Medicine

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):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海市公共卫生临床中心 

单位级别:

三级甲等医院 

Institution
hospital:

Shanghai Public Health Clinical Center  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

体温复常时间

指标类型:

主要指标 

Outcome:

Time for body temperature recovery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺炎胸部CT吸收情况

指标类型:

主要指标 

Outcome:

Chest CT absorption

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核酸转阴时间

指标类型:

主要指标 

Outcome:

Time of nucleic acid test 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:

血常规

指标类型:

次要指标 

Outcome:

Routine blood 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:

C反应蛋白

指标类型:

次要指标 

Outcome:

C-reactive protein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

Blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化指标

指标类型:

次要指标 

Outcome:

Biochemical Indicators

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心酶

指标类型:

次要指标 

Outcome:

Heart enzyme 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:

尿常规

指标类型:

次要指标 

Outcome:

routine urine 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:

大便常规

指标类型:

次要指标 

Outcome:

Fecal routine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

次要指标 

Outcome:

blood glucose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

细胞因子

指标类型:

次要指标 

Outcome:

cytokine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候量表

指标类型:

次要指标 

Outcome:

TCM Syndrome Scale

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 event

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:

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):

不进行随机分组

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

N/A

盲法:

N/A

Blinding:

N/A

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):

不公开

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

Private

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

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

Case Report Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-07
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