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芪归银方治疗重症肺炎有效性与安全性的多中心、随机双盲、安慰剂对照试验
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注册号:

Registration number:

ChiCTR1800019785 

最近更新日期:

Date of Last Refreshed on:

2018-11-28 

注册时间:

Date of Registration:

2018-11-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

芪归银方治疗重症肺炎有效性与安全性的多中心、随机双盲、安慰剂对照试验 

Public title:

Efficacy and safety of the Qi-Gui-Yin formula on severe pneumonia: a multicenter, randomized, double-blinded, placebo-controlled clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

芪归银方治疗重症肺炎有效性与安全性的多中心、随机双盲、安慰剂对照试验 

Scientific title:

Efficacy and safety of the Qi-Gui-Yin formula on severe pneumonia: a multicenter, randomized, double-blinded, placebo-controlled clinical trial 

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:

黄坡 

研究负责人:

刘清泉 

Applicant:

Huang Po 

Study leader:

Liu Qingquan 

申请注册联系人电话:

Applicant telephone:

+86 18811412783 

研究负责人电话:

Study leader's telephone:

+86 010-52176677 

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:

huangpo1992@126.com 

研究负责人电子邮件:

Study leader's E-mail:

liuqingquan_2003@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:

北京市东城区美术馆后街23号 

研究负责人通讯地址:

北京市东城区美术馆后街23号 

Applicant address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

Study leader's address:

23 Back Street of Art Gallery, 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:

首都医科大学附属北京中医医院 

Applicant's institution:

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University 

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:

2018BL-053-02 

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:

首都医科大学附属北京中医医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Beijing hospital of Traditional Chinese Medicine affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-21 

伦理委员会联系人:

王晶 

Contact Name of the ethic committee:

Wang Jing 

伦理委员会联系地址:

北京市东城区美术馆后街23号 

Contact Address of the ethic committee:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-64011516 

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:

北京市中医研究所 

Primary sponsor:

Beijing institute of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

北京市东城区美术馆后街23号 

Primary sponsor's address:

23 Back Street of Art Gallery, Dongcheng 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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市中医研究所

具体地址:

北京市东城区美术馆后街23号

Institution
hospital:

Beijing Institute of Traditional Chinese Medicine

Address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China

经费或物资来源:

北京市卫生和计划生育委员会 

Source(s) of funding:

Beijing municipal commission of health and family planning 

研究疾病:

重症肺炎 

Target disease:

Severe pneumonia 

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:

I期临床试验 

Study phase:

研究目的:

评价芪归银方治疗重症肺炎的临床有效性与安全性 

Objectives of Study:

To evaluate the efficacy and safety of Qi-Gui-Yin formula on severe pneumonia 

药物成份或治疗方案详述:

试验组和对照组分别在常规治疗的基础上给予芪归银方颗粒剂温开水冲制,200毫升/次,2次/日或芪归银安慰剂温开水冲制,200毫升/次,2次/日 

Description for medicine or protocol of treatment in detail:

On the basis of conventional treatment, the experimental group and the control group were respectively given Qi-Gui-Yin formula granules, 200 ml/time, 2 times/day or Qi-Gui-Yin placebo granules, 200 ml/time, 2 times/day 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)符合重症肺炎的诊断标准; (2)18岁≤年龄≤80岁; (3)患者或家属知晓研究内容,并自愿签署知情同意书。 

Inclusion criteria

(1) meet the diagnostic criteria of severe pneumonia; (2) Aged 18 to 80 years; (3) patients or their families are aware of the study content and sign the informed consent voluntarily. 

排除标准:

(1)妊娠或准备妊娠者,或不能采取有效措施避孕者; (2)严重的精神疾患者; (3)因基础疾病导致患者预期生存时间少于28天,如恶性肿瘤控制不佳,既往30天内发生心跳骤停等; (4)植物生存状态; (5)确诊或高度疑似急性传染性疾病,如病毒性肝炎活动期、活动期肺结核等; (6)对试验药物有效成分或其辅料过敏; (7)近3个月内参加过临床干预试验; (8)主治医生认为不宜参加本试验的受试者。 

Exclusion criteria:

(1) pregnancy or pregnancy preparation, or unable to take effective measures to prevent pregnancy; (2) persons with serious mental disorders; (3) the expected survival time of patients due to basic diseases is less than 28 days, such as poor control of malignant tumors and cardiac arrest within 30 days in the past; (4) plant survival state; (5) confirmed or highly suspected acute infectious diseases, such as viral hepatitis active stage, active stage tuberculosis, etc.; (6) allergy to the effective ingredients or auxiliary materials of the test drugs; (7) participated in clinical intervention trials in the past 3 months; (8) subjects who are considered unfit to participate in this study by the attending doctor. 

研究实施时间:

Study execute time:

From2018-01-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2019-01-01To 2020-11-30 

干预措施:

Interventions:

组别:

对照组

样本量:

265

Group:

Control group

Sample size:

干预措施:

芪归银安慰剂颗粒剂,200毫升/次,2次/日

干预措施代码:

Intervention:

Qi-Gui-Yin placebo granules, 200 ml/time and 2 times/day

Intervention code:

组别:

试验组

样本量:

265

Group:

Experimental group

Sample size:

干预措施:

芪归银颗粒剂,200毫升/次,2次/日

干预措施代码:

Intervention:

Qi-Gui-Yin formula granules, 200 ml/time, 2 times/day

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):

首都医科大学附属北京中医医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing hospital of Traditional Chinese Medicine affiliated to Capital Medical University  

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):

首都医科大学附属北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing friendship hospital affiliated to Capital Medical University  

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):

中国中医科学院广安门医院 

单位级别:

三级甲等 

Institution
hospital:

Guang 'anmen hospital, the Chinese academy of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospita 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院西苑医院 

单位级别:

三级甲等 

Institution
hospital:

Xiyuan hospital, Chinese academy of traditional Chinese medicine  

Level of the institution:

Tertiary A hospita 

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):

北京中医药大学东方医院 

单位级别:

三级甲等 

Institution
hospital:

Oriental hospital, Beijing university of traditional Chinese medicine  

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:

The first affiliated 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):

山东中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated hospital of Shandong university of traditional Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

河南省中医院 

单位级别:

三级甲等 

Institution
hospital:

Henan hospital of traditional Chinese medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

28天病死率

指标类型:

主要指标 

Outcome:

28-day mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气时间

指标类型:

次要指标 

Outcome:

Mechanical ventilation 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:

ICU住院时间

指标类型:

次要指标 

Outcome:

Length of ICU stays

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗生素DDD值

指标类型:

次要指标 

Outcome:

Antibiotic DDD value

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

Length of hospital stays

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PSI评分

指标类型:

次要指标 

Outcome:

PSI Score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SOFA评分

指标类型:

次要指标 

Outcome:

SOFA Score

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:

CRP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

降钙素原

指标类型:

次要指标 

Outcome:

PCT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

痰标本培养

指标类型:

次要指标 

Outcome:

Sputum specimen culture

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

副作用指标 

Outcome:

blood routine examination

Type:

Adverse events 

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:

副作用指标 

Outcome:

routine urine test

Type:

Adverse events 

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:

副作用指标 

Outcome:

stool routine examination

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

Electrocardiogram

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙氨酸氨基转移酶

指标类型:

副作用指标 

Outcome:

Alanine aminotransferase

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

天冬氨酸氨基转移酶

指标类型:

副作用指标 

Outcome:

Aspartic acid amino transferase

Type:

Adverse events 

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:

副作用指标 

Outcome:

Total bilirubin

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐

指标类型:

副作用指标 

Outcome:

creatinine

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿素氮

指标类型:

副作用指标 

Outcome:

Urea nitrogen

Type:

Adverse events 

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:

副作用指标 

Outcome:

Adverse events

Type:

Adverse events 

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:

外周静脉

Sample Name:

blood

Tissue:

Peripheral venous

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:

feces

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:

痰液

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:

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:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

由专业人员使用SAS9.4软件生成随机数字表。

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

A random number table is generated by a professional using SAS9.4 software.

盲法:

根据确定好的分组方案在相应试验用药或安慰剂外包装袋上印上序列号,参与纳入受试者以及受试者无法知晓接受的药物为试验药或安慰剂。

Blinding:

Serial Numbers will be printed on the packaging of the corresponding experimental drugs or placebo according to the determined grouping scheme, and the participants and the subjects will be unaware that the drugs accepted are the experimental drugs or placebo.

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):

Pubmed

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

Pubmed

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:

Epidata

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

Epidata

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-11-28
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