Clinical study of Lian Bizhi injection in the treatment of adult community-acquired pneumonia

注册号:

Registration number:

ITMCTR2000003510

最近更新日期:

Date of Last Refreshed on:

2020-07-24

注册时间:

Date of Registration:

2020-07-24

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

莲必治注射液治疗成人社区获得性肺炎的临床研究

Public title:

Clinical study of Lian Bizhi injection in the treatment of adult community-acquired pneumonia

注册题目简写:

English Acronym:

研究课题的正式科学名称:

莲必治注射液治疗成人社区获得性肺炎(痰热壅肺证)有效性和安全性的随机、双盲、安慰剂平行对照、多中心临床试验

Scientific title:

A randomized, double-blind, placebo-controlled, multi-center clinical trial on the effectiveness and safety of Lian Bizhi injection in the treatment of adult community-acquired pneumonia (phlegm-heat obstructing lung syndrome)

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2000034912 ; ChiMCTR2000003510

申请注册联系人:

齐蕊涵

研究负责人:

张洪春

Applicant:

Qi Ruihan

Study leader:

Zhang Hongchun

申请注册联系人电话:

Applicant telephone:

+86 18811555031

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:

460189252@qq.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):

Study leader's 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:

北京市朝阳区北三环11号北京中医药大学

研究负责人通讯地址:

北京市朝阳区樱花东街2号

Applicant address:

11 North Third Ring Road East, Chaoyang District, Beijing, China

Study leader's address:

2 East Yinghua Road, 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:

北京中医药大学

Applicant's institution:

Beijing University of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2018-9-K05

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:

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:

1990/1/1 0:00:00

伦理委员会联系人:

余中光

Contact Name of the ethic committee:

Yu Zhongguang

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 East Yinghua Road, 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 East Yinghua Road, 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):

江苏省

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏九旭药业有限公司

具体地址:

江苏省徐州市睢宁县经济开发区九旭大道88号

Institution
hospital:

Jiangsu Jiuxu Pharmaceutical Co., Ltd.

Address:

88 Jiuxu Avenue, Yanning County Economic Development Zone, Xuzhou

经费或物资来源:

申办单位赞助

Source(s) of funding:

Sponsored by Jiangsu Jiuxu Pharmaceutical Co., Ltd.

研究疾病:

社区获得性肺炎

研究疾病代码:

Target disease:

community-aquired pneumonia

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

上市后药物

Post-marketing clinical trial

研究目的:

通过开展莲必治注射液联合抗生素(盐酸左氧氟沙星注射液)治疗成人社区获得性肺炎(痰热壅肺证)的临床试验,评价莲必治注射液治疗成人社区获得性肺炎(痰热壅肺证)的有效性和安全性。分析莲必治注射液联合抗生素(盐酸左氧氟沙星注射液)治疗成人社区获得性肺炎(痰热壅肺证)作用的特点和优势。

Objectives of Study:

Through the development of clinical trials of Lian Bizhi injection combined with antibiotics (levofloxacin hydrochloride injection) in the treatment of adult community-acquired pneumonia (phlegm-heat in the lung syndrome), to evaluate the efficacy and safety,as well as to analyze the characteristics and advantages of Lian Bizhi injection in the treatment of adult community-acquired pneumonia.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

以下标准筛选时必须全部符合方可纳入试验 (1) 符合成人社区获得性肺炎诊断的住院病人; (2) 中医辨证为痰热壅肺证; (3) 体温≥37.5℃; (4) CURB-65评分≤2分; (5) 肺炎PSI评分属低危Ⅰ~Ⅲ级(≤90分); (6) 年龄在18~65岁(含18和65岁),性别不限; (7) 自愿参加临床试验,并签署知情同意书。

Inclusion criteria

All of the following criteria must be met during screening before being included in the trial: (1) Inpatients who meet the diagnosis of adult community-acquired pneumonia; (2) TCM syndrome differentiation is the syndrome of phlegm-heat obstructing the lung; (3) Body temperature >=37.5 degree C; (4) CURB-65 score <=2 points; (5) The PSI score for pneumonia belongs to low-risk grade I to III (<=90 points); (6) Aged 18 to 65 years old; (7) Volunteer to participate in clinical trials and sign informed consent.

排除标准:

以下标准筛选时必须全部不符合方可纳入试验 (1) 慢性咽炎、慢性阻塞性肺疾病、支气管哮喘、肺纤维化、肺结核、百日咳、急性扁桃体炎、真菌、肿瘤等因素所致咳嗽; (2) 筛选前一周内使用过抗生素和抗病毒药物治疗者,包括对肺炎有治疗作用的中药和中成药; (3) 糖尿病血糖控制不佳者(此处“血糖控制不佳”指的是“空腹血糖>7.0mmol/L”者); (4) 有中枢神经系统疾病及癫痫史者; (5) 肾功能Scr大于参考值上限;肝功能ALT、AST>1.5倍参考值上限者; (6) 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,精神病患者; (7) 过敏体质,及对本研究药物有效成分(亚硫酸氢钠穿心莲内酯)、盐酸左氧氟沙星注射液以及辅料过敏者; (8) 妊娠或计划妊娠的女性,哺乳期妇女,试验期间不能或不愿意采取充分避孕的育龄期患者或其配偶不愿意采取避孕措施者; (9) 3个月内参加或正在参加其他药物临床试验者; (10) 根据研究者的判断,不宜参加本研究者。

Exclusion criteria:

All of the following criteria must not be met during screening before being included in the trial: (1) Cough caused by chronic pharyngitis, chronic obstructive pulmonary disease, bronchial asthma, pulmonary fibrosis, tuberculosis, whooping cough, acute tonsillitis, fungus, tumor and other factors; (2) Those who have used antibiotics and antiviral drugs within one week before screening, including Chinese medicines and proprietary Chinese medicines that have a therapeutic effect on pneumonia; (3) Diabetics with poor blood sugar control ("Poor blood sugar control" here refers to those with "fasting blood sugar>7.0mmol/L"); (4) Those with a history of central nervous system diseases and epilepsy; (5) Kidney function Scr is greater than the upper limit of the reference value; liver function ALT, AST>1.5 times the upper limit of the reference value; (6) Patients with severe primary diseases of the cardio-cerebrovascular, liver and kidney hematopoietic system and endocrine system, and mental patients; (7) Allergic physique, and those who are allergic to the active ingredient of the drug (sodium bisulfite and andrographolide), levofloxacin hydrochloride injection and excipients; (8) Women who are pregnant or planning to become pregnant, breastfeeding women, patients of childbearing age who are unable or unwilling to take adequate contraception during the trial, or their spouses who are unwilling to take contraceptive measures; (9) Participated in or are participating in other drug clinical trials within 3 months; (10) According to the judgment of the researcher, it is not suitable to participate in this research.

研究实施时间:

Study execute time:

From 2018-07-09

To      2019-12-27

征募观察对象时间:

Recruiting time:

From 2018-07-09

To      2019-12-27

干预措施:

Interventions:

组别:

对照组

样本量:

120

Group:

control

Sample size:

干预措施:

盐酸左氧氟沙星注射液+莲必治注射液模拟剂

干预措施代码:

Intervention:

Hydrochloric acid left oxyfluorate injection + Lian Bizhi Injection Simulation Agent

Intervention code:

组别:

试验组

样本量:

120

Group:

experiment group

Sample size:

干预措施:

盐酸左氧氟沙星注射液+莲必治注射液

干预措施代码:

Intervention:

Hydrochloric acid left oxyfluorate injection + Lian Bizhi Injection

Intervention code:

样本总量 Total sample size : 240

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:

三甲医院

Institution/hospital:

China-Japan Friendship Hospital

Level of the institution:

Tertiary A Hospital

国家:

中国

省(直辖市):

内蒙古自治区

市(区县):

Country:

China

Province:

Inner Mongolia Autonomous Region

City:

单位(医院):

内蒙古自治区中医医院

单位级别:

三甲医院

Institution/hospital:

Chinese Medicine Hospital in Inner Mongolia Autonomous Region

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):

天津中医药大学第二附属医院

单位级别:

三甲医院

Institution/hospital:

Second Affiliated Hospital, Tianjin University of Traditional Chinese Medicine

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

体格检查

指标类型:

次要指标

Outcome:

Medical examination

Type:

Secondary indicator

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:

次要指标

Outcome:

Urine routine

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:

次要指标

Outcome:

Blood routine

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

次要指标

Outcome:

kidney function

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

次要指标

Outcome:

liver function

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温复常时间

指标类型:

主要指标

Outcome:

Time to normal body temperature

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

即刻起效时间

指标类型:

主要指标

Outcome:

Immediate onset time

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

初始治疗有效率

指标类型:

主要指标

Outcome:

Initial treatment efficiency

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

初始治疗失败率

指标类型:

主要指标

Outcome:

Initial treatment failure rate

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

退热药使用情况

指标类型:

主要指标

Outcome:

Use of antipyretics

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中性粒细胞计数

指标类型:

主要指标

Outcome:

Neutrophil count

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CRP值

指标类型:

主要指标

Outcome:

CRP value

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部啰音评分

指标类型:

主要指标

Outcome:

Lung rale score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

十二导联心电图

指标类型:

次要指标

Outcome:

12-lead ECG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咳嗽VAS评分

指标类型:

主要指标

Outcome:

VAS rating of cough

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血白细胞计数

指标类型:

主要指标

Outcome:

White blood cell count

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

痰量评分

指标类型:

主要指标

Outcome:

Sputum volume score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ESR值

指标类型:

主要指标

Outcome:

ESR value

Type:

Primary 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:

主要指标

Outcome:

Theoretical discharge time

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命体征

指标类型:

次要指标

Outcome:

vital signs

Type:

Secondary 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:

标本中文名:

组织:

Sample Name:

phlegm

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:

结束

Completed

年龄范围:

最小
Min age years
最大
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由不参与本项目统计分析工作的专业人员利用SAS软件产生随机编码,用区组随机方法,将随机号001-240的受试者按照1:1的比例进行随机分组

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

Professionals who are not involved in the statistical analysis of this project use SAS software to generate random codes, and use the block random method to randomly group subjects with random numbers 001-240 at a ratio of 1:1

盲法:

双盲

Blinding:

Double blind

是否共享原始数据:

IPD sharing:

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):

论文发表

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

Paper publication

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:

本试验采用纸质病例报告表(CRF)作为数据载体,病例报告表(CRF)一式三份(无碳复写)由研究者填写,研究者保证数据真实、完整、准确。试验记录所有项目均填写,做任何更正时划线,旁注改后的数据,由研究者签名并注明日期,无擦涂、覆盖原始记录。 每例入选病例均填写完整的CRF,完成后的CRF由该中心研究者审核签署。临床监查员原数据核查(Source Data Verification,SDV),确保CRF数据与原始文件一致。 临床监查员确认后收集CRF,第一联移交数据管理员进行数据录入与管理工作。第一联移交后,CRF的内容不再做任何修改。 数据录入由独立的数据管理单位负责,数据录入采用独立双人双份方式进行。数据管理员以及医学人员对数据进行逐一审核,审核中发现的问题以疑问表形式通过临床监查员向研究者询问,由研究者回答并签字确认。数据管理员根据研究者的答疑进行数据修改、确认,修改的内容如实记录在答疑表中。必要时再次发出疑问表,直到数据疑问清理完毕。

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

This experiment uses a paper case report form (CRF) as the data carrier. The case report form (CRF) is filled in by the researcher in triplicate (carbon-free replication), and the researcher guarantees that the data is true, complete and accurate. All items in the test record are filled out, and any corrections are made with a line. The revised data shall be marked and dated by the investigator, and the original record shall be overwritten without rubbing. Each selected case is filled in a complete CRF, and the completed CRF will be reviewed and signed by the center's researchers. The source data verification (SDV) of clinical monitors ensures that the CRF data is consistent with the original documents. After the clinical monitor confirms, the CRF will be collected, and the first link will be handed over to the data manager for data entry and management. After the transfer of the first page, the content of the CRF will no longer be modified. Data entry is in the charge of an independent data management unit, and data entry is carried out in an independent double copy mode. Data administrators and medical personnel review the data one by one, and the questions found during the review are asked by the clinical monitor in the form of a question form, and the researcher answers and signs for confirmation. The data administrator will modify and confirm the data according to the question and answer of the researcher, and the content of the modification shall be truthfully recorded in the question and answer sheet. If necessary, issue the question form again until the data question is cleared.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above