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Cancelled by the investigator Clinical guidance of diagnose and treatment for novel coronavirus pneumonia (COVID-19) based on ''Shi-Du-Yi''
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注册号:

Registration number:

ChiCTR2000030765 

最近更新日期:

Date of Last Refreshed on:

2020-03-17 

注册时间:

Date of Registration:

2020-03-13 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

研究者撤消 基于“湿毒疫”理论对普通型和重型新型冠状病毒肺炎(COVID-19)的诊疗方案的临床指导作用 

Public title:

Cancelled by the investigator Clinical guidance of diagnose and treatment for novel coronavirus pneumonia (COVID-19) based on ''Shi-Du-Yi'' 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于“湿毒疫”理论对普通型和重型新型冠状病毒肺炎的诊疗方案的临床指导作用 

Scientific title:

Clinical guidance of diagnose and treatment for novel coronavirus pneumonia (COVID-19) based on ''Shi-Du-Yi'' 

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:

宋国林 

研究负责人:

宋国林 

Applicant:

GuoLin Song 

Study leader:

GuoLin Song 

申请注册联系人电话:

Applicant telephone:

+86 13985004689 

研究负责人电话:

Study leader's telephone:

+86 13985004689 

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:

ant000999@126.com 

研究负责人电子邮件:

Study leader's E-mail:

ant000999@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:

贵州省贵阳市飞山街32号 

研究负责人通讯地址:

贵州省贵阳市飞山街32号 

Applicant address:

32 Feishan Street, Guiyang, Guizhou, China 

Study leader's address:

32 Feishan Street, Guiyang, Guizhou, China 

申请注册联系人邮政编码:

Applicant postcode:

550000 

研究负责人邮政编码:

Study leader's postcode:

550000 

申请人所在单位:

贵州中医药大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine 

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:

贵州中医药大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine 

研究实施负责(组长)单位地址:

贵州省贵阳市飞山街32号 

Primary sponsor's address:

32 Feishan Street, Guiyang, Guizhou, 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):

贵州省

市(区县):

贵阳市

Country:

China

Province:

Guizhou

City:

单位(医院):

贵州中医药大学第二附属医院

具体地址:

贵州省贵阳市飞山街32号

Institution
hospital:

The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine

Address:

32 Feishan Street, Guiyang

经费或物资来源:

课题 

Source(s) of funding:

project 

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:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

本研究主要收集了 2019 年国家和省公布的防治新冠肺炎方案,筛选符合“湿毒疫”范畴中药处方。使用 R 软件对中药字段采用二值量化处理,对治疗普通型和重型类处方进行药物频数及关联规则分析,得出相关结果;并基于对贵州、鄂州和武汉三个城市中抽取已用的符合“湿毒疫”范畴中药处方,对普通型和重型临床特征,进行分析。探讨“湿毒疫”在治疗普通型和重型新冠肺炎方案中的作用,为临床应用中医药治疗新冠肺炎提供参考和依据。 

Objectives of Study:

This study collected the novel coronavirus pneumonia Program published by the state and province in 2019, and screened the Chinese herbal medicine prescription that accords with the category of "damp toxin epidemic". The R software was used to quantify the field of traditional Chinese medicine. The frequency and association rules of common and heavy prescriptions were analyzed, and the relevant results were obtained. The common and heavy clinical characteristics were analyzed based on the traditional Chinese medicine prescriptions that had been used in Guizhou, Ezhou and Wuhan. Novel coronavirus pneumonia in the treatment of novel coronavirus pneumonia and severe pneumonia in the treatment of new type of pneumonia, and provide a reference for clinical application of Chinese medicine in treating new 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:

连续入组 

Study design:

Sequential 

纳入标准:

普通型和重型新冠状病毒肺炎 

Inclusion criteria

Common and severe new coronavirus pneumonia 

排除标准:

轻型和危重型新冠状病毒肺炎 

Exclusion criteria:

Mild and critical new coronavirus pneumonia 

研究实施时间:

Study execute time:

From2019-12-01To 2021-12-31 

干预措施:

Interventions:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

贵州 

市(区县):

贵阳 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵州将军山医院 

单位级别:

三甲医院 

Institution
hospital:

Guizhou Jiangjunshan hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

鄂州市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Ezhou Central Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

预后

指标类型:

主要指标 

Outcome:

prognosis

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:

组织:

Sample Name:

biood

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 1 years
最大 Max age 99 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):

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

No

盲法:

No

Blinding:

No

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):

Clinical Trial Management Public Platform

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

Clinical Trial Management Public Platform

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:

ResMan

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

ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-13
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