今天是:2022-07-07 星期四

痰热清口服液治疗急性支气管炎(痰热阻肺证)有效性和安全性的随机、双盲、安慰剂对照、多中心临床试验
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注册号:

Registration number:

ChiCTR2000040264 

最近更新日期:

Date of Last Refreshed on:

2021-02-15 

注册时间:

Date of Registration:

2020-11-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

痰热清口服液治疗急性支气管炎(痰热阻肺证)有效性和安全性的随机、双盲、安慰剂对照、多中心临床试验 

Public title:

Efficacy and Safety of Tanreqing Oral Liquid in Treatment of Acute Bronchitis (Phlegm-Heat Obstructing Lungs Syndrome): a multicenter, randomized, double-blind, placebo-controlled trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

痰热清口服液治疗急性支气管炎(痰热阻肺证)有效性和安全性的随机、双盲、安慰剂对照、多中心临床试验 

Scientific title:

Efficacy and Safety of Tanreqing Oral Liquid in Treatment of Acute Bronchitis (Phlegm-Heat Obstructing Lungs Syndrome): a multicenter, randomized, double-blind, placebo-controlled 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:

ChiMCTR2100004437 

申请注册联系人:

蒋红丽 

研究负责人:

毛兵 

Applicant:

Hongli Jiang 

Study leader:

Bing Mao 

申请注册联系人电话:

Applicant telephone:

+86 18980606651 

研究负责人电话:

Study leader's telephone:

+86 18980601724 

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:

doc_jhl@163.com 

研究负责人电子邮件:

Study leader's E-mail:

maobing@medmail.com.cn 

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:

成都外南国学巷37号 

研究负责人通讯地址:

成都外南国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2018临床试验中药审(6)号 

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:

四川大学华西医院临床试验伦理委员会 

Name of the ethic committee:

Ethics Committee on Clinical Trials, West China Hospital, Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-13 

伦理委员会联系人:

刘伦旭 

Contact Name of the ethic committee:

Lunxu Liu 

伦理委员会联系地址:

成都外南国学巷37号 

Contact Address of the ethic committee:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都外南国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海凯宝药业股份有限公司

具体地址:

上海工业综合开发区程普路88号

Institution
hospital:

Shanghai Kaibao Pharmaceutical Co., Ltd

Address:

88 Chengpu Road, Shanghai Industrial Comprehensive Development Zone, Shanghai

经费或物资来源:

上海凯宝药业股份有限公司 

Source(s) of funding:

Shanghai Kaibao Pharmaceutical Co., Ltd 

研究疾病:

急性支气管炎 

Target disease:

acute bronchitis 

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:

III期临床试验 

Study phase:

研究目的:

评价痰热清口服液治疗急性支气管炎(痰热阻肺证)的有效性和安全性。 

Objectives of Study:

This trial aims to evaluate the efficacy and safety Tanreqing oral liquid in treatment of acute bronchitis with phlegm-heat obstructing lungs syndrome. 

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.符合急性气管--支气管炎诊断标准; 2.符合中医痰热阻肺证诊断标准; 3.咳嗽症状总积分≥4分; 4.中医症状分级标准中咯痰≥6分; 5.气管炎严重程度评分表≥6分; 6.年龄在18~65岁之间,男女不限; 7.病程在72小时之内; 8.自愿接受该药治疗,并签署知情同意书; 

Inclusion criteria

1. Diagnosis of acute trachea-bronchitis; 2. Phlegm-heat obstructing lungs syndrome in traditional Chinese medicine 'Zheng'; 3. Total cough symptom score >=4 points; 4. Expectoration in traditional Chinese medicine symptom score >=6 points; 5. Bronchitis severity score>=6 points; 6. Disease course within 72 hours; 7. Aged 18 to 65 years old; 8. Voluntarily provide written and informed consent. 

排除标准:

1.慢性阻塞性肺疾病、支气管扩张、哮喘、肺癌、肺结核、肺炎、肺脓肿及胸部X线片显示肺部炎症病变等呼吸系统疾病患者; 2.合并心脑血管、肺、肾和造血系统严重原发性疾病;心电图提示异常且有临床意义者; 3.吸烟患者; 4.使用ACEI类药物; 5.体温≥38.5℃的患者; 6.肝功能检测值(ALT、AST)超过正常值上限1.5倍;Scr高于正常参考值上限;尿蛋白>+;血白细胞小于3.0×10^9/L或大于10.0×10^9/L、和/或中性粒细胞百分比>80%;或需要合并抗生素治疗者; 7.发病后已使用过治疗本病的其他药物者(包括抗生素、祛痰、镇咳药、全身或吸入性激素以及吸入支气管扩张剂或辛凉解表或清热解毒等相关中药); 8.妊娠、哺乳期妇女及近3个月有妊娠计划者; 9.过敏体质者或对该药物已知成分过敏者; 10.影响其生存的严重疾病(如肿瘤等)及精神病患者; 11.1个月内参加过其他药物临床试验及目前正在参加其他药物临床试验的患者; 12.研究者认为存在有不适合入选因素的患者。 

Exclusion criteria:

1. Patients with respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer, tuberculosis, pneumonia, lung abscess and chest X-ray showing lung inflammation lesions; 2. Patient with severe underlying cardiac, cerebral, hematological, hepatic or renal disorders or other diseases significantly affecting the survival and prognosis, such as cancer; 3. Current smokers or recent ex-smokers quitting smoking less than 1 month ago; 4. Use of an angiotensin-converting-enzyme inhibitor in the last 1 month 5. Patients with body temperature>=38.5 degree C; 6. ALT or AST>1.5 ULN, urine protein>+, serum creatine abnormality, white blood cell count<3x10^9/L or >10x10^9/L, and or neutrophil granulocyte>80%, or those who need antibiotic therapy; 7. Those who have used other medicines after disease onset including antibiotics, expectorants, antitussives, systemic or inhaled corticosteroids, inhaled bronchodilators, Chinese medicines of relieving exterior syndrome with pungent-cool drugs, clearing away heat and detoxification and other related Chinese medicines; 8. Pregnant or lactating women and those who have pregnancy plans in the last 3 months; 9. Allergic constitution or known to be allergic to any ingredients in tested drug; 10. Mental patients or legal disability; 11. Patients who have participated or are currently participating in another clinical trial in the last one month; 12. Patients who are inappropriate for participation judged by researchers. 

研究实施时间:

Study execute time:

From2020-11-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2020-11-23To 2021-12-31 

干预措施:

Interventions:

组别:

痰热清组

样本量:

180

Group:

Tanreqing group

Sample size:

干预措施:

痰热清口服液 20ml 一天3次

干预措施代码:

Intervention:

Tanreqing oral liquid 20 ml three times daily

Intervention code:

组别:

安慰剂组

样本量:

90

Group:

placebo group

Sample size:

干预措施:

安慰剂口服液 20ml 一天3次

干预措施代码:

Intervention:

placebo oral liquid 20 ml three times daily

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

贵州 

市(区县):

 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵州中医药大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

the First Affiliated Hospital of Guizhou University of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

广西中医药大学附属瑞康医院 

单位级别:

三甲医院 

Institution
hospital:

Ruikang Hospital Affiliated to Guangxi University of Chinese medicine  

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):

上海市中医医院 

单位级别:

三甲医院 

Institution
hospital:

Chinese Medicine Hospital of Shanghai  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

 

单位(医院):

湖南中医药大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

the First Affiliated Hospital of Hunan University of Chinese medicine  

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):

上海市闵行区中心医院 

单位级别:

二甲 

Institution
hospital:

Central Hospital of Minhang District, Shanghai  

Level of the institution:

Second A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三甲医院 

Institution
hospital:

Guangdong Provincial Hospital of 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):

天津中医药大学附属第二医院 

单位级别:

三甲医院 

Institution
hospital:

Second Affiliated Hospital of Tianjin University of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

咳嗽消失率

指标类型:

主要指标 

Outcome:

Cough resolution 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:

支气管炎严重程度积分变化

指标类型:

次要指标 

Outcome:

Change of bronchitis severity scores from baseline to post-treatment

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咳嗽缓解率

指标类型:

次要指标 

Outcome:

Cough relief 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:

咳嗽消失时间

指标类型:

次要指标 

Outcome:

Time to cough resolution

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咳嗽缓解时间

指标类型:

次要指标 

Outcome:

Time to cough relief

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医单项症状消失率

指标类型:

次要指标 

Outcome:

Resolution rate of single TCM symptom

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

合并用药

指标类型:

次要指标 

Outcome:

Combination medication use

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候积分变化

指标类型:

次要指标 

Outcome:

Change of TCM syndrome score from baseline to post-treatment

Type:

Secondary indicator 

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:

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:

大便

组织:

Sample Name:

stool

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:

小便

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:

正在进行

Recruiting

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):

试验方案采用中心分层区组随机化方法。独立的统计学专家利用SAS9.4 统计专业软件产生2列共270例受试者所接受处理(试验药、对照药)的随机安排,受试者按照2∶1 分配比例随机分配至痰热清组和安慰剂组。

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

Central stratified block randomization method will be used in this trial. Two columns of 270 random arrangements of treatments (trial drugs and control drugs ratio of 2:1) will be generated by an independent statistician using Statistical Analysis System SAS (SAS 9.4).

盲法:

双盲

Blinding:

Double blin

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):

投稿时附件上传

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

uploading attachments by contributors

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:

本研究采用电子采集和管理系统采集和管理数据

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

This trial will use electronic data capture(EDC) to collect and manage data.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-26
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