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Studies on infectious studies of Bacillus thuringiensis and non-fermented bacteria which Base on traditional Chinese medicine
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注册号:

Registration number:

ChiCTR-ORC-17011760 

最近更新日期:

Date of Last Refreshed on:

2017-06-26 

注册时间:

Date of Registration:

2017-06-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

基于“菌毒并治”理论中医药治疗泛耐药肠杆菌科及非发酵细菌感染的研究 

Public title:

Studies on infectious studies of Bacillus thuringiensis and non-fermented bacteria which Base on traditional Chinese medicine  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于“菌毒并治”理论中医药治疗泛耐药肠杆菌科及非发酵细菌感染的研究 

Scientific title:

Studies on infectious studies of Bacillus thuringiensis and non-fermented bacteria which Base on Traditional Chinese Medicine  

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:

蔡阳平 

研究负责人:

刘清泉 

Applicant:

Yangping Cai 

Study leader:

Qingquan Liu 

申请注册联系人电话:

Applicant telephone:

+86 13911613943 

研究负责人电话:

Study leader's telephone:

+86 13910055687 

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:

cyp931@163.com 

研究负责人电子邮件:

Study leader's E-mail:

liuqingquan2003@yahoo.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:

北京市通州区翠屏西路116号东直门医院东区 

研究负责人通讯地址:

北京市东城区美术馆后街23号 

Applicant address:

116 Cuiping Road West, Tongzhou District, Beijing, China 

Study leader's address:

23 Back Street, Art Galary, Dongcheng District, Beijing, 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:

北京中医药大学东直门医院 

Applicant's institution:

Dongzhimen Hospital Beijing 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:

北京中医药大学东直门医院 

Primary sponsor:

Dongzhimen Hospital Beijing University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

北京市通州区翠屏西路116号东直门医院东区 

Primary sponsor's address:

116 Cuiping Road West, Tongzhou District, Beijing, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家中医药管理局

具体地址:

北京市东城区工体西路1号

Institution
hospital:

state administration of traditional chinese

Address:

1 Gongti Road West, Dongcheng District, Beijing

经费或物资来源:

中华人民共和国 国家中医药管理局传染病防治09年行业专项 

Source(s) of funding:

The state administration of traditional Chinese medicine of the People's Republic of China has an infectious disease control system for the year of 2009 

研究疾病:

泛耐药肠杆菌科及非发酵细菌感染 

Target disease:

The People's Republic of China state administration of traditional Chinese medicine industry special infectious disease prevention and control of 09 years 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

本课题基于“菌毒并治”这一重要中医药理论,开展中医药治疗泛耐药肠杆菌科细菌感染性疾病的研究,评价中医药在泛耐药肠杆菌科细菌感染性疾病治疗中的疗效、安全性和经济价值,优化筛选有效的中药制剂和中医诊治方案,降低危重症病例的发生率以及病死率,为制定中医药治疗泛耐药肠杆菌科细菌感染性疾病的有效途径和手段提供科学依据。 

Objectives of Study:

This theory of traditional Chinese medicine about fungus poisonous and governance is a approach for research about treatment of generic drug resistant enterobacteriaceae bacterial infectious disease by traditional Chinese medicine, evaluation of traditional Chinese medicine in generic drug resistant enterobacteriaceae efficacy in the treatment of bacterial infectious diseases security and economic value, optimizing and diagnosis and treatment , reduce the incidence of critical cases and case fatality rate. Finally providing a scientific and effective ways for the development of traditional Chinese medicine treatment on generic drug resistant enterobacteriaceae bacterial infectious diseases.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

(1)细菌培符合鲍曼不动杆菌、铜绿假单胞菌、肺炎克雷伯杆菌、大肠杆菌一种或多种菌阳性 (2)临床符合肺部、泌尿系、术后伤口感染一项或一项以上诊断 

Inclusion criteria

(1) the bacterial culture was positive which consistent with one or more bacteria,as baumann, pseudomonas aeruginosa, klebsiella pneumonia; (2) clinical compliance with lung, urinary tract, postoperative wound infection or more than one diagnosis. 

排除标准:

各类精神病者、参加其他临床试验者、妊娠期或哺乳期妇女、对中药过敏者 

Exclusion criteria:

Various types of psychotics participating in other clinical trials pregnancy or lactation, allergic to Chinese medicine 

研究实施时间:

Study execute time:

From2009-10-01To 2014-06-30 

征募观察对象时间:

Recruiting time:

From2014-01-01To 2014-04-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

496

Group:

treatment group

Sample size:

干预措施:

中药治疗

干预措施代码:

Intervention:

treatment by Chinese herbs

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三级甲等 

Institution
hospital:

Dongzhimen Hospital Beijing University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Friendship Hospital Capital Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东省中医院 

单位级别:

三级甲等 

Institution
hospital:

Shandong traditional Chinese medicine hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南省 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南省中医医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Province Hospital of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

白细胞

指标类型:

主要指标 

Outcome:

WBC

Type:

Primary 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:

主要指标 

Outcome:

CRP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中性粒细胞百分比

指标类型:

主要指标 

Outcome:

NE%

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血小板

指标类型:

主要指标 

Outcome:

PLT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白

指标类型:

主要指标 

Outcome:

Hgb

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肌酐

指标类型:

主要指标 

Outcome:

cr

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血尿素氮

指标类型:

主要指标 

Outcome:

BUN

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆红素

指标类型:

主要指标 

Outcome:

TBLL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清白蛋白

指标类型:

主要指标 

Outcome:

ALB

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静脉血糖

指标类型:

主要指标 

Outcome:

GIU

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:

sputum

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:

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:

切口分泌物

组织:

Sample Name:

Incision secretion

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:

结束

Completed

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):

回顾性病例分析,非随机试验

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

It was retrospective case analysis, non-randomized trial.

盲法:

Blinding:

是否共享原始数据:

IPD sharing

No

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):

通过ResMan查询,原始数据个人保存,如需要请与实施负责人联系

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

IPD will be public accessable via ResMan (The original data is saved. Please contact the implementation manager if necessary)

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:

Excel表格形式

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

Excel

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-06-26
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