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八宝丹用于新型冠状病毒肺炎(COVID-19)重症患者辅助治疗
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注册号:

Registration number:

ChiCTR2000029769 

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:

八宝丹用于新型冠状病毒肺炎(COVID-19)重症患者辅助治疗 

Public title:

Babaodan Capsule used for the adjuvant treatment of severe novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

八宝丹用于新型冠状病毒肺炎(COVID-19)重症患者辅助治疗 

Scientific title:

Babaodan Capsule used for the adjuvant treatment of severe 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:

 

申请注册联系人:

蒋永泼 

研究负责人:

吕冬青 

Applicant:

Jiang Yongpo 

Study leader:

Lv Dongqing 

申请注册联系人电话:

Applicant telephone:

+86 13736580663 

研究负责人电话:

Study leader's telephone:

+86 13867622009 

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:

jyongpo8@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lvdq@enzemed.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:

浙江省临海市西门街150号 浙江省台州医院 

研究负责人通讯地址:

台州市路桥区桐杨路东1号 

Applicant address:

150 Ximen Street, Taizhou, Zhejiang, China 

Study leader's address:

1 Tongyang Road East, Luqiao District, Taizhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

317000 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

浙江省台州医院 

Applicant's institution:

Taizhou 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:

无 

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:

台州市恩泽医疗中心(集团)恩泽医院 医院伦理委员会 

Name of the ethic committee:

Hospital Ethics Committee of Enze Hospital of Taizhou Enze Medical Center (Group) 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-12 

伦理委员会联系人:

汪官富 

Contact Name of the ethic committee:

Wang Guangfu 

伦理委员会联系地址:

台州市路桥区桐杨路东1号 

Contact Address of the ethic committee:

1 Tongyang Road East, Luqiao District, Taizhou, Zhejiang, 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:

台州市恩泽医疗中心(集团)恩泽医院 

Primary sponsor:

Enze Hospital of Taizhou Enze Medical Center (Group) 

研究实施负责(组长)单位地址:

台州市路桥区桐杨路东1号 

Primary sponsor's address:

1 Tongyang Road East, Luqiao District, Taizhou, 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

市(区县):

台州

Country:

China

Province:

Zhejiang

City:

taizhou

单位(医院):

恩泽医院

具体地址:

台州市路桥区桐杨路东1号

Institution
hospital:

Enze Hospital

Address:

1 Tongyang Road East, Luqiao District, Taizhou

经费或物资来源:

台州市科技计划项目 

Source(s) of funding:

Taizhou Science and Technology Plan 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:

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:

观察八宝丹对新型冠状病毒肺炎患者的炎症及预后影响 

Objectives of Study:

To observe the effect of Babaodan on inflammation and prognosis of Severe novel coronavirus pneumonia patients  

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:

重症患者(符合下列任意一条):呼吸窘迫(RR>30次/分);静息状态下,指氧饱和度<=93%; 动脉血氧分压(PaO2)/吸氧浓度 (FiO2)<=300 mmHg  

Inclusion criteria

Severe patients (according to any of the following): respiratory distress (RR> 30 beats / min); at rest, means oxygen saturation <= 93%; arterial oxygen pressure (PaO2) / oxygen concentration (FiO2) < = 300 mmHg 

排除标准:

儿童、孕妇 

Exclusion criteria:

Children, pregnant women 

研究实施时间:

Study execute time:

From2020-02-15To 2020-04-30 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

Experimental group

Sample size:

干预措施:

常规治疗+八宝丹 6粒,bid 口服

干预措施代码:

Intervention:

Routine treatment + Babaodan 6 capsules, bid orally

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

台州 

Country:

China 

Province:

Zhejiang 

City:

Taizhou 

单位(医院):

台州市恩泽医疗中心(集团)恩泽医院 

单位级别:

三甲医院 

Institution
hospital:

Enze Hospital of Taizhou Enze Medical Center (Group)  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

28天预后情况

指标类型:

主要指标 

Outcome:

28-day survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症因子水平

指标类型:

主要指标 

Outcome:

Inflammatory factor levels

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:

全血

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:

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 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):

采用随机数字表

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

random number table

盲法:

未说明

Blinding:

Not stated

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):

网上

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

web

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 Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-13
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