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王丽新医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 中西医结合治疗新型冠状病毒肺炎 (COVID-19) 的临床研究
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注册号:

Registration number:

ChiCTR2000029790 

最近更新日期:

Date of Last Refreshed on:

2020-02-14 

注册时间:

Date of Registration:

2020-02-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

王丽新医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 中西医结合治疗新型冠状病毒肺炎 (COVID-19) 的临床研究  

Public title:

Clinical study for the integration of traditional Chinese and western 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:

中西医结合治疗新型冠状病毒肺炎 (COVID-19) 的临床研究  

Scientific title:

Clinical study for the integration of traditional Chinese and western 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:

ChiMCTR2000003009 

申请注册联系人:

王丽新 

研究负责人:

王丽新 

Applicant:

Lixin Wang 

Study leader:

Lixin Wang 

申请注册联系人电话:

Applicant telephone:

+86 18917962300 

研究负责人电话:

Study leader's telephone:

+86 18917962300 

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:

wlx1126@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

wlx1126@hotmail.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:

上海市杨浦区政民路507号 

研究负责人通讯地址:

上海市杨浦区政民路507号 

Applicant address:

507 Zhengmin Road, Yangpu District, Shanghai, China  

Study leader's address:

507 Zhengmin Road, Yangpu 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:

上海市肺科医院 

Applicant's institution:

Shanghai Pulmonary Hospital  

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:

上海市肺科医院 

Primary sponsor:

Shanghai Pulmonary Hospital  

研究实施负责(组长)单位地址:

上海市杨浦区政民路507号 

Primary sponsor's address:

507 Zhengmin Road, Yangpu 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(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市肺科医院

具体地址:

杨浦区政民路507号

Institution
hospital:

Shanghai Pulmonary Hospital

Address:

507 Zhengmin Road, Yangpu District

经费或物资来源:

同济大学 

Source(s) of funding:

Tongji University 

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:

为了明确解表化湿解毒法治疗湿毒郁肺型新冠病毒肺炎的临床疗效,为完善中医药防治新冠肺炎方案提供科学依据。 

Objectives of Study:

In order to clarify the clinical efficacy of the method of relieving exterior dampness and detoxification in the treatment of dampness toxin depression lung type of novel coronavirus pneumonia, and to provide a scientific basis for improving the Chinese medicine treatment of 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)符合西医诊断和分型标准,符合中医症候标准。 (2)年龄18-80周岁。 (3)自愿参加本研究并签署书面知情同意书者。 

Inclusion criteria

(1) Comply with the standards of diagnosis and classification of western medicine, and the standards of syndromes of traditional Chinese medicine. (2) Aged 18-80 years. (3) Those who voluntarily participated in this research and signed written informed consent. 

排除标准:

(1)意识障碍或精神疾患不能配合治疗观察者。 (2)严重脏器功能不全者。 (3)孕妇。 

Exclusion criteria:

(1) Impaired consciousness or mental illness cannot cooperate with treating the observer. (2) Those with severe organ dysfunction. (3) Pregnant women. 

研究实施时间:

Study execute time:

From2020-02-17To 2020-10-31 

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:

Western medicine basic treatment

Intervention code:

组别:

治疗组

样本量:

60

Group:

Experimental group

Sample size:

干预措施:

西医基础治疗+中药

干预措施代码:

Intervention:

Western medicine basic treatment combined with 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):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市肺科医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Pulmonary Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

中医症候疗效

指标类型:

主要指标 

Outcome:

TCM symptoms efficacy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

普通型危重症转化率

指标类型:

次要指标 

Outcome:

Conversion rate of common and critical illness

Type:

Secondary 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:

次要指标 

Outcome:

Nucleic acid negative 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:

退热时间

指标类型:

次要指标 

Outcome:

Antipyretic 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:

住院天数

指标类型:

次要指标 

Outcome:

The number of days in hospital

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:

stool

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:

分泌物

组织:

Sample Name:

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 18 years
最大 Max age 80 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):

借助SPSS23.0统计分析系统产生120个随机数。

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

Generate 120random numbers with SPSS23.0 statistical analysis system.

盲法:

Not stated

Blinding:

Not stated

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):

上海市肺科医院官网 http://www.shsfkyy.com/

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

the official web of Shanghai Pulmonary Hospital http://www.shsfkyy.com/

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:

病历记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-13
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