A multicenter, randomized, double-blind, placebo-controlled trial for Tanreqing capsule in the treatment of acute exacerbation of mild to moderate COPD

注册号:

Registration number:

ITMCTR2000003143

最近更新日期:

Date of Last Refreshed on:

2020-03-21

注册时间:

Date of Registration:

2020-03-21

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

痰热清胶囊联合治疗轻中度慢阻肺急性加重期住院患者的多中心、随机、双盲、安慰剂对照的临床研究

Public title:

A multicenter, randomized, double-blind, placebo-controlled trial for Tanreqing capsule in the treatment of acute exacerbation of mild to moderate COPD

注册题目简写:

English Acronym:

研究课题的正式科学名称:

痰热清胶囊联合治疗轻中度慢阻肺急性加重期住院患者的多中心、随机、双盲、安慰剂对照的临床研究

Scientific title:

A multicenter, randomized, double-blind, placebo-controlled trial for Tanreqing capsule in the treatment of acute exacerbation of mild to moderate COPD

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:

ChiCTR2000031080 ; ChiMCTR2000003143

申请注册联系人:

徐贵华

研究负责人:

徐贵华

Applicant:

Xu Guihua

Study leader:

Xu Guihua

申请注册联系人电话:

Applicant telephone:

+86 13585636986

研究负责人电话:

Study leader's telephone:

+86 13585636986

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:

noan9602@163.com

研究负责人电子邮件:

Study leader's E-mail:

noan9602@163.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:

上海市浦东新区张衡路528号

研究负责人通讯地址:

上海市浦东新区张衡路528号

Applicant address:

528 Zhangheng Road, Pudong New District, Shanghai, China

Study leader's address:

528 Zhangheng Road, Pudong New District, Shanghai, 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:

上海中医药大学附属曙光医院

Applicant's institution:

Shuguang Hospital Affiliated to Shanghai University of traditional 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:

2019-781-136-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2013/8/26 0:00:00

伦理委员会联系人:

耿希

Contact Name of the ethic committee:

Geng Xi

伦理委员会联系地址:

上海市浦东新区张衡路528号

Contact Address of the ethic committee:

528 Zhangheng Road, Pudong New District, Shanghai, 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:

上海中医药大学附属曙光医院

Primary sponsor:

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市浦东新区张衡路528号

Primary sponsor's address:

528 Zhangheng Road, Pudong New District, Shanghai, 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):

上海市松江区中心医院

具体地址:

上海市松江区 中山中路748号

Institution
hospital:

Shanghai Songjiang District Central Hospital

Address:

748 Zhongshan Middle Road, Songjiang District, Shanghai

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属上海市第五人民医院

具体地址:

上海市闵行区鹤庆路801号

Institution
hospital:

Shanghai Fifth People's Hospital Affiliated to Fudan University

Address:

801 Heqing Road, Minhang District

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

具体地址:

上海市浦东新区张衡路528号

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

Address:

528 zhangheng Road, Pudong New District

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市浦东新区人民医院

具体地址:

上海市浦东新区川沙镇川环南路490号

Institution
hospital:

Shanghai Pudong New Area People's Hospita

Address:

490 Chuanhuan Road South, Chuansha town, Pudong New District

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市闵行区中心医院

具体地址:

上海市闵行区莘庄镇莘松路170号

Institution
hospital:

Shanghai Minhang District Central Hospital

Address:

170 Xinsong Road, Xinzhuang Town, Minhang District, Shanghai

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属同仁医院

具体地址:

上海市长宁区仙霞路1111号

Institution
hospital:

Tongren Hospital Affiliated to Medical College of Shanghai Jiaotong University

Address:

1111 Xianxia Road, Changning District, Shanghai

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属中山医院

具体地址:

上海市徐汇区枫林路180号

Institution
hospital:

Zhongshan Hospital Affiliated to Fudan University

Address:

180 Fenglin Road, Xuhui District

经费或物资来源:

上海市科委和上海凯宝药业股份有限公司

Source(s) of funding:

Shanghai Science and Technology Commission and Shanghai Kaibao Pharmaceutical Co., Ltd

研究疾病:

慢性阻塞性肺疾病

研究疾病代码:

Target disease:

Chronic obstructive pulmonary disease

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:

探讨痰热清胶囊治疗轻中度慢性阻塞性肺疾病急性加重期(AECOPD)患者的临床研究,完成240例,明确有效性和安全性;并探索痰热清胶囊治疗AECOPD适宜的中医“证素”特点。

Objectives of Study:

To explore the clinical study of Tanreqing capsule in the treatment of acute exacerbation of mild to moderate chronic obstructive pulmonary disease (AECOPD), 240 cases are completed, the efficacy and safety are clarified, and to explore the characteristics of TCM "syndrome elements" suitable for Tanreqing capsule in the treatment of AECOPD.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1)年龄40~80岁,性别不限; 2)轻中度的COPD患者:符合慢性阻塞性肺病全球倡议(GOLD)及中华医学会呼吸病学会分会制定COPD的诊断标准:既往一年有肺功能诊断的报告,即吸入支气管扩张剂后FEV1/FVC<70%;FEV1占预计值的百分比>50%; 3)符合慢性阻塞性肺疾病急性发作期(AECOPD)的诊断标准:与稳定期相比,受试者病情持续恶化,超过日间正常变化,即有 COPD 基础的受试者为急性起病,需要调整常规用药; 4)具有发热、咳嗽、咳黄脓痰等临床表现; 5)影像学检查:符合慢性支气管炎、肺气肿等表现,或者合并有肺部渗出影。排除肺结核、肺部肿瘤、肺动脉栓塞、间质性肺病及肺水肿等疾病; 6)受试者充分理解并自愿签署知情同意书。

Inclusion criteria

1. Aged 40-80 years old; 2. Patients with mild to moderate COPD: meet the diagnostic criteria of COPD formulated by the global initiative for chronic obstructive pulmonary disease (gold) and the society of respiratory diseases of Chinese Medical Association: there was a previous year's report of pulmonary function diagnosis, that is, FEV1 / FVC was less than 70% after inhalation of bronchodilator; FEV1 accounted for more than 50% of the predicted value; 3. Patients who meet the diagnostic criteria of acute stage of chronic obstructive pulmonary disease (AECOPD): compared with the stable stage, the patients' condition continues to worsen, exceeding the normal changes during the day, that is, the patients with COPD are acute onset, and need to adjust the routine medication; 4. Patients with fever, cough, yellow cough, purulent phlegm and other clinical manifestations; 5. The imaging examination is consistent with the manifestations of chronic bronchitis and emphysema, or with pulmonary exudation shadow. Patients with pulmonary tuberculosis, pulmonary tumor, pulmonary embolism, interstitial lung disease and pulmonary edema were excluded; 6. Subjects who fully understood and voluntarily signed the informed consent.

排除标准:

1)已知对试验用药物所含成分及药用辅料过敏者; 2)支气管哮喘、支气管扩张症、肺间质纤维化、肺动脉高压、重度肺部感染、重度慢性阻塞性肺疾病急性加重期、肺结核、结核性胸膜炎、呼吸衰竭以及需要呼吸机辅助治疗的等患者; 3)既往或目前合并以下任何一种重大疾病史或影响研究评估: ? 无力咳痰(如长期卧床、晚期肺癌等)患者; ? 近3个有脑血管意外病史,如缺血性脑卒中和出血性脑卒中; ? 病态窦房结综合征、II~III度房室传导阻滞、房扑、房颤及其它恶性或潜在的恶性心律失常; ? 大动脉瘤或夹层动脉瘤、行经皮冠状动脉腔内成形术或心脏外科手术; ? 近3个月内有不稳定性心绞痛、心肌梗死、心力衰竭史; ? 严重的肝病患者或肝功能不全的患者(如肝硬化、慢性活动性肝炎等); ? 严重的肾病患者(如慢性肾功能不全者、肾动脉狭窄患者等); ? 恶性肿瘤病史; ? 严重的造血系统原发性疾病者或粒细胞缺乏症者。 4)入组前有任何一项实验室检查指标符合下列标准: ? 丙氨酸氨基转氨酶(ALT)、天门冬氨酸氨基转移酶(AST)>1.5倍正常值上限(ULN)(参考所在的研究中心实验室检查正常值范围); ? 血清肌酐(Cr)>1.5倍正常值上限(ULN)(参考所在的研究中心实验室检查正常值范围)。 5)其他不适合参加研究的一般情况: ? 筛选前3个月内曾参加过或正在参加其它任何临床试验者; ? 既往有吸毒、酒精或药物滥用病史; ? 存在严重神经、精神疾患而不能充分理解和合作的患者; ?妊娠、哺乳、计划怀孕或未采取可靠节育措施的育龄期妇女和男性患者,并在参加试验期间和末次用药后的30天内不愿意采取节育方法,育龄期妇女要查尿HCG; ? 无法遵从研究方案要求者; ? 研究者认为其他不适宜参加临床试验的情况者。

Exclusion criteria:

1. Patients who are known to be allergic to the ingredients and excipients of the test drug; 2. Patients with bronchial asthma, bronchiectasis, pulmonary fibrosis, pulmonary hypertension, severe pulmonary infection, acute exacerbation of severe chronic obstructive pulmonary disease, tuberculosis, tuberculous pleurisy, respiratory failure, and those requiring ventilator-assisted treatment; 3. Patients who have been or are currently being evaluated in any of the following major disease histories or impact studies: (1) Patients with inability to expectorate (such as long-term bed rest, advanced lung cancer, etc.); (2) Nearly 3 patients had history of cerebrovascular accident, such as ischemic stroke and hemorrhagic stroke; (3) Sick sinus syndrome, degree II-III atrioventricular block, atrial flutter, atrial fibrillation and other malignant or potential malignant arrhythmias; (4) Large aneurysm or dissecting aneurysm, percutaneous transluminal coronary angioplasty or cardiac surgery; (5) Unstable angina, myocardial infarction and heart failure were found in the past 3 months; (6) Patients with severe liver disease or liver dysfunction (such as cirrhosis, chronic active hepatitis, etc.); (7) Patients with severe nephropathy (such as chronic renal insufficiency, renal artery stenosis, etc.); (8) History of malignant tumor; (9) Severe primary disease of hematopoietic system or agranulocytosis. 4. Patients with any laboratory test index meeting the following criteria before enrollment: (1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 1.5 times the upper limit of normal value (ULN) (refer to the range of normal value in the laboratory of the research center); (2) Serum creatinine (CR) is more than 1.5 times the upper limit of normal value (ULN) (refer to the range of normal value in the laboratory of the research center). 5. Other general conditions that are not suitable for the study: (1) Patients who have participated in or are participating in any other clinical trials within 3 months before screening; (2) Patients with previous histories of drug, alcohol or drug abuse; (3) Patients with severe neurological and mental disorders who cannot fully understand and cooperate; (4) Women and men of childbearing age who are pregnant, lactating, planning to be pregnant or who do not take reliable birth control measures are not willing to take birth control methods during the trial period and within 30 days after the last medication. HCG in urine should be checked in women of childbearing age; (5) Patients who are unable to comply with the requirements of the study protocol; (6) Other situations that the researchers think are not suitable for clinical trials.

研究实施时间:

Study execute time:

From 2020-03-20

To      2022-10-31

征募观察对象时间:

Recruiting time:

From 2020-03-20

To      2022-10-31

干预措施:

Interventions:

组别:

对照组

样本量:

80

Group:

control group

Sample size:

干预措施:

西医基础治疗,加用安慰剂胶囊3粒,每日3次,口服

干预措施代码:

Intervention:

Basic treatment of Western medicine, plus 3 placebo capsules, 3 times a day, oral

Intervention code:

组别:

试验A组

样本量:

80

Group:

Experimental group A

Sample size:

干预措施:

西医基础治疗,加用痰热清胶囊3粒,每日3次,口服。

干预措施代码:

Intervention:

Western medicine basic treatment, plus three Tanreqing capsules, three times a day, oral.

Intervention code:

组别:

试验B组

样本量:

80

Group:

Experimental group B

Sample size:

干预措施:

西医基础治疗,加用痰热清胶囊2粒+安慰剂胶囊1粒,每日3次口服。

干预措施代码:

Intervention:

Western medicine basic treatment, add 2 Tanreqing capsules + 1 placebo capsule, take orally 3 times a day.

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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市松江区中心医院

单位级别:

二甲医院

Institution/hospital:

Shanghai Songjiang District Central Hospital

Level of the institution:

Secondary A Hospital

国家:

中国

省(直辖市):

上海市

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:

二甲医院

Institution/hospital:

Shanghai Minhang District Central Hospital

Level of the institution:

Secondary A Hospital

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市浦东新区人民医院

单位级别:

二甲医院

Institution/hospital:

Shanghai Pudong New Area People's Hospita

Level of the institution:

Secondary 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曙光医院

单位级别:

三甲医院

Institution/hospital:

Shuguang Hospital Affiliated to Shanghai University of traditional 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):

上海交通大学医学院附属同仁医院

单位级别:

三甲医院

Institution/hospital:

Tongren Hospital Affiliated to Medical College of Shanghai Jiaotong 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:

三甲医院

Institution/hospital:

Zhongshan Hospital Affiliated to 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):

复旦大学附属上海市第五人民医院

单位级别:

三乙医院

Institution/hospital:

Zhongshan Hospital Affiliated to Fudan University

Level of the institution:

Tertiary B Hospital

测量指标:

Outcomes:

指标中文名:

肺功能

指标类型:

次要指标

Outcome:

Pulmonary 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:

呼吸困难、咳嗽与咳痰量表

指标类型:

主要指标

Outcome:

Dyspnea, cough and expectoration scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

痰培养

指标类型:

次要指标

Outcome:

Sputum 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:

中医临床证素指标

指标类型:

主要指标

Outcome:

TCM clinical syndrome index

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标

Outcome:

Routine blood test

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:

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:

标本中文名:

大便

组织:

Sample Name:

shit

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 40
Min age years
最大 80
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):

课题负责人根据随机数字表产生随机序列

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

The project leader generates random sequence according to random number table.

盲法:

未说明

Blinding:

Not stated

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):

Not stated

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

Not stated

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:

病例记录表

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

Case Record Form

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):

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