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中西医协同治疗感染导致的慢阻肺急性加重效果和机制研究
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注册号:

Registration number:

ChiCTR1800016915 

最近更新日期:

Date of Last Refreshed on:

2018-07-03 

注册时间:

Date of Registration:

2018-07-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中西医协同治疗感染导致的慢阻肺急性加重效果和机制研究 

Public title:

Study for the effect and mechanism of Chinese and western medicine in the treatment of infection induced acute exacerbation of COPD 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中西医协同治疗感染导致的慢阻肺急性加重效果和机制研究 

Scientific title:

Study for the effect and mechanism of Chinese and western medicine in the treatment of infection induced acute exacerbation of COPD 

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:

雷翔 

研究负责人:

张洪春 

Applicant:

Lei Xiang 

Study leader:

Zhang Hongchun 

申请注册联系人电话:

Applicant telephone:

+86 13803091193 

研究负责人电话:

Study leader's telephone:

+86 13701226664 

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:

leixiang@qhcro.com 

研究负责人电子邮件:

Study leader's E-mail:

13701226664@139.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:

北京市朝阳区樱花东街2号 

研究负责人通讯地址:

北京市朝阳区樱花东街2号 

Applicant address:

2 Yinghua Street East, Chaoyang District, Beijing, China 

Study leader's address:

2 Yinghua Street East, Chaoyang 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:

中日友好医院 

Applicant's institution:

China-Japan Friendship Hospital  

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:

2018-56-k40-1 

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:

中日友好医院临床研究伦理委员会 

Name of the ethic committee:

Clinical research ethics committee of China-Japan Friendship Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

陈燕芬 

Contact Name of the ethic committee:

CHEN Yanfen 

伦理委员会联系地址:

北京市朝阳区樱花东街2号 

Contact Address of the ethic committee:

2 Yinghua Street East, Chaoyang District, Beijing, 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:

中日友好医院 

Primary sponsor:

China-Japan Friendship Hospital  

研究实施负责(组长)单位地址:

北京市朝阳区樱花东街2号 

Primary sponsor's address:

2 Yinghua Street East, Chaoyang 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):

中日友好医院

具体地址:

北京市朝阳区樱花东街2号

Institution
hospital:

China-Japan Friendship Hospital

Address:

2 Yinghua Street East, Chaoyang District, Beijing, China

经费或物资来源:

中华人民共和国科学技术部 

Source(s) of funding:

Ministry of Science and Technology of the People's Republic of China 

研究疾病:

慢阻肺急性加重 

Target disease:

AECOPD 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

探索新加宣白承气汤联合西医治疗感染致慢阻肺急性加重患者的效果及作用机制。 

Objectives of Study:

To explore the effect and action mechanism of xuanbaichengqi decoction combined with western medicine in the treatment of patients with acute exacerbation of chronic obstructive pulmonary infection. 

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AECOPD诊断标准; (2) AECOPD严重程度临床分级为I-II级; (3) 具有AECOPD诊治中国专家共识(2017修订版)推荐的接受抗菌药物治疗的指征; (4) 符合中医痰热腑实证辨证标准; (5) 年龄40-80周岁,性别不限; (6) 自愿参加本项临床试验,知情同意并签署知情同意书。 

Inclusion criteria

1. Meets the diagnostic criteria of COPD; 2. The clinical grade of severity of COPD was I-II; 3. The patient has indications for antibiotic treatment(Consensus of Chinese experts on diagnosis and treatment of AECOPD (revised edition 2017)); 4. Diagnosed with Phlegm-Heat Excess Syndrome; 5. Aged 40 to 80 years old; 6. Those who signed the informed consent form. 

排除标准:

(1) 合并哮喘、支气管扩张、肺囊性纤维化、肺结核纤维化病变、肺癌或其他已知病因及具有特征病理表现的气流受限疾病者; (2) 冠心病、高血压性心脏病、心脏瓣膜疾病等引起劳力性气促的疾病者; (3) 具有有创机械通气应用指征者; (4) 临床高度怀疑或确诊合并肺栓塞者; (5) 合并严重心脑血管、肝肾造血系统和内分泌系统原发性疾病者; (6) 合并需要外科干预的肠梗阻者; (7) 妊娠及哺乳期妇女; (8) 智力障碍,精神障碍者; (9) ALT、AST>正常参考值上限1.5倍或Scr>正常参考值上限者; (10) 需要合并使用免疫抑制剂者; (11) 筛选前口服抗生素超过3天或静脉途径使用过抗生素者; (12) 已知对方案规定的基础治疗药物或任何辅料过敏者; (13) 已知对中药处方药物成分过敏者; (14) 近3个月内参加过或正在参加其他临床试验者; (15) 研究者认为不适宜参加本临床试验者。 

Exclusion criteria:

1. patients with asthma, bronchiectasis, pulmonary cystic fibrosis, pulmonary fibrosis, lung cancer or other known causes and airflow limitation diseases with characteristic pathological manifestations; 2. patients with coronary heart disease, hypertensive heart disease, cardiac valve diseases and other diseases that cause labor force shortness; 3. having indications for the application of invasive mechanical ventilation; 4. patients with high clinical suspicion or diagnosis of pulmonary embolism; 5. patients with serious primary diseases of cardio-cerebrovascular, hepatic and renal hematopoietic system and endocrine system; 6. patients with intestinal obstruction requiring surgical intervention; 7. Pregnant and lactating women; 8. Mental retardation, mental retardation; 9. Liver and kidney function Scr>1.0ULN, ALT(AST) >1.5ULN; 10. People who need a combination of immunosuppressive agents; 11. Those who have used oral antibiotics for more than 3 days before screening or who have used antibiotics intravenously; 12. those who are known to be allergic to the basic therapeutic drugs; 13. those who are known to be allergic to the pharmaceutical ingredients prescribed by Chinese medicine; 14. those who have participated in or are participating in other clinical trials within the last 3 months; 15. the researcher thinks that it is inappropriate to participate in this clinical trial. 

研究实施时间:

Study execute time:

From2018-07-01To 2020-12-01 

征募观察对象时间:

Recruiting time:

From2018-08-01To 2019-07-01 

干预措施:

Interventions:

组别:

试验组1

样本量:

120

Group:

Experimental group 1

Sample size:

干预措施:

新加宣白承气复方免煎颗粒+吸入用布地奈德混悬液(2ml)

干预措施代码:

Intervention:

XCBQT+Budesonide Suspension for inhalation (2)

Intervention code:

组别:

试验组2

样本量:

120

Group:

Experimental group 2

Sample size:

干预措施:

新加宣白承气复方免煎颗粒+吸入用布地奈德混悬液(1ml)

干预措施代码:

Intervention:

XCBQT+Budesonide Suspension for inhalation (1ml)

Intervention code:

组别:

试验组2

样本量:

120

Group:

Experimental group 2

Sample size:

干预措施:

新加宣白承气复方免煎颗粒+吸入用布地奈德混悬液(1ml)

干预措施代码:

Intervention:

XCBQT+Budesonide Suspension for inhalation (1ml)

Intervention code:

组别:

对照组

样本量:

120

Group:

control group

Sample size:

干预措施:

吸入用布地奈德混悬液(2ml)+新加宣白承气复方免煎颗粒安慰剂

干预措施代码:

Intervention:

XCBQT placebo+Budesonide Suspension for inhalation (2ml)

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):

中日友好医院 

单位级别:

三级甲等 

Institution
hospital:

China-Japan Friendship Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

中国医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of China Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属中山医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongshan hospital affiliated Fudan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin Hospital, Shanghai Jiao Tong University School of 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):

中国中医科学院望京医院 

单位级别:

三级甲等 

Institution
hospital:

Wangjing hospital of China Academy of Chinese Medical Sciences  

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):

中国中医科学院西苑医院 

单位级别:

三级甲等 

Institution
hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

临床症状

指标类型:

主要指标 

Outcome:

clinical symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状

指标类型:

主要指标 

Outcome:

clinical symptoms

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活动能力(mMRC)

指标类型:

次要指标 

Outcome:

capacity for action (mMRC)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清炎症标志物

指标类型:

次要指标 

Outcome:

Serum inflammatory markers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清炎症标志物

指标类型:

次要指标 

Outcome:

Serum inflammatory markers

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:

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:

理论出院时间

指标类型:

次要指标 

Outcome:

Theoretical discharge 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:

死亡率

指标类型:

次要指标 

Outcome:

death rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

有创机械通气患者比例

指标类型:

次要指标 

Outcome:

The proportion of patients with invasive mechanical ventilation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

转入ICU患者比例

指标类型:

次要指标 

Outcome:

Proportion of patients admitted to ICU

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院后30天内再入院率

指标类型:

次要指标 

Outcome:

Readmission rate within 30 days after discharge

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候积分

指标类型:

次要指标 

Outcome:

TCM 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:

中医证候疗效评价

指标类型:

次要指标 

Outcome:

Clinical evaluation of TCM syndrome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

气道微生物组学

指标类型:

附加指标 

Outcome:

Airway microbiology

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道微生物组学

指标类型:

附加指标 

Outcome:

enteromicrobiology

Type:

Additional 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:

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 40 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):

由第三方应用软件产生随机数字表,并由不参与本实验的专门数据处里者保存

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

The random number will be generated by the SAS software and saved in a envelop by statistical profes

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

向研究者索取

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

Asking for the researcher

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-07-03
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