今天是:2022-01-25 星期二

健脾舒肺颗粒治疗早期COPD的多中心随机对照临床研究
下载XML文档

注册号:

Registration number:

ChiCTR2100053827 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

健脾舒肺颗粒治疗早期COPD的多中心随机对照临床研究 

Public title:

Jianpi Shufei Granule for Early-stage Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Placebo-controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

健脾舒肺颗粒治疗早期COPD的多中心随机对照临床研究 

Scientific title:

Jianpi Shufei Granule for Early-stage Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, 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:

ChiMCTR2100005359 

申请注册联系人:

陈远彬 

研究负责人:

林琳 

Applicant:

Yuanbin Chen 

Study leader:

Lin Lin 

申请注册联系人电话:

Applicant telephone:

15920174645 

研究负责人电话:

Study leader's telephone:

81887233-38605 

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:

chenyuanbin110@163.com 

研究负责人电子邮件:

Study leader's E-mail:

drlinlin620@163.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:

广东省广州市越秀区大德路111号 

研究负责人通讯地址:

广东省广州市越秀区大德路111号 

Applicant address:

111 Dade Road, Guangzhou,Guangdong, China  

Study leader's address:

111 Dade Road, Guangzhou,Guangdong, 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:

广东省中医院 

Applicant's institution:

Guangdong Provincial Hospital of Chinese Medicine  

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:

BF-2021-129-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangdong Hospital of Traditional Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2021-07-09 

伦理委员会联系人:

李晓彦 

Contact Name of the ethic committee:

Xiaoyan Li 

伦理委员会联系地址:

广东省广州市越秀区大德路111号 

Contact Address of the ethic committee:

111 Dade Road, Guangzhou, Guangdong, 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:

广东省中医院 

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine  

研究实施负责(组长)单位地址:

广东省广州市越秀区大德路111号 

Primary sponsor's address:

111 Dade Road, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

广东省广州市越秀区大德路111号

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine

Address:

111 Dade Road, Guangzhou, Guangdong, China

经费或物资来源:

广东省中医院中医药科学技术研究专项 

Source(s) of funding:

Guangdong Provincial Hospital of Traditional Chinese Medicine Science and Technology Research Project 

研究疾病:

慢性阻塞性肺疾病 

Target disease:

Chronic Obstructive Pulmonary Disease 

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:

探索性研究/预试验 

Study phase:

研究目的:

评估健脾舒肺颗粒治疗早期COPD的疗效及安全性 

Objectives of Study:

This study aims to assess the clinical efficacy and safety of Jian Pi Shu Fei granules for early-stage COPD. 

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:

①40岁≤年龄<85岁,男女均可;②符合GOLD定义的COPD诊断标准,分级为1-2级,处于稳定期;③中医辨证为气虚痰阻;④签署知情同意书并同意分享信息。 

Inclusion criteria

①Patients who are aged 40–85 years; ②Patients who meet the diagnostic criteria of COPD, stage I-II, with stable stage; ③Patients who meet the Chinese medicine syndrome classification of Qi deficiency and phlegm obstruction; ④Patients who sign the written informed consent form. 

排除标准:

①合并支气管哮喘、支气管扩张、阻塞性睡眠呼吸暂停综合征、肺恶性肿瘤、活动性肺结核患者;②中医辨证以阴虚为主证;③入组前4周内曾发生过急性加重的COPD患者;④对任何研究药物成分有过敏或超敏反应史,或被研究者认为已知患有应禁止使用参加研究药物的疾病;⑤不能配合完成肺功能检测者;⑥长期服用中药药膳(如黄芪、人参、党参等中药材)调理的患者;⑦合并严重心脑血管、肝肾疾病或精神疾病患者;⑧血谷丙转氨酶(ALT)、谷草转氨酶(AST)或血肌酐(Scr)超过正常值上限的1.5倍者;⑨依从性差者;⑩筛选访视前1个月内接受过任何试验用药品治疗者;?在筛选期内参加或计划参加其他临床试验者。 

Exclusion criteria:

①Patients with asthma,bronchiectasis,obstructive sleep apnea syndrome,lung malignant tumors or active pulmonary tuberculosis;②Chinese medicine syndrome based on Yin deficiency;③Patients with acute exacerbation of COPD within 4 weeks before enrollment;④Patients with history of allergies or hypersensitivity for any research drug component, or the researcher believes that it is known to have a disease that should not be participated in research;⑤Those who cannot complete the lung function test; ⑥Long-term of traditional Chinese medicine diet (astragalus, ginseng) and other Chinese medicinal materials);⑦Patients with severe cardiovascular, cerebrovascular, liver and kidney disease;⑧Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or serum creatinine (Scr) exceed 1.5 times the upper limit of normal value;⑨Poor compliance;⑩Patients who have received any experimental drug treatment within 1 month;?Patients who Participated in or plan to participate in other clinical trials. 

研究实施时间:

Study execute time:

From2021-09-01To 2024-08-31 

征募观察对象时间:

Recruiting time:

From2021-11-30To 2024-02-29 

干预措施:

Interventions:

组别:

试验组

样本量:

49

Group:

Experimental group

Sample size:

干预措施:

健脾舒肺颗粒

干预措施代码:

Intervention:

Jian Pi Shu Fei granules

Intervention code:

组别:

对照组

样本量:

49

Group:

Control group

Sample size:

干预措施:

健脾舒肺颗粒安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省中医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

东莞 

Country:

China 

Province:

Guangdong 

City:

Dongguan 

单位(医院):

东莞市中西医结合医院 

单位级别:

三级 

Institution
hospital:

Dongguan Hospital of Integrated Traditional Chinese and Western Medicine  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市番禺区中医院 

单位级别:

三级甲等 

Institution
hospital:

Panyu Hospital of Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江西 

市(区县):

南昌 

Country:

China 

Province:

Jiangxi 

City:

Nanchang 

单位(医院):

江西中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Jiangxi University of Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

CAT评分

指标类型:

主要指标 

Outcome:

CAT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺功能参数

指标类型:

次要指标 

Outcome:

lung 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:

年人均急性加重发生次数

指标类型:

次要指标 

Outcome:

Acute exacerbation per year

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首次出现急性加重的时间

指标类型:

次要指标 

Outcome:

Time to first exacerbation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CCQ 问卷

指标类型:

次要指标 

Outcome:

CCQ

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CASA 评分

指标类型:

次要指标 

Outcome:

CASA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

mMRC 问卷

指标类型:

次要指标 

Outcome:

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:

6分钟步行距离

指标类型:

次要指标 

Outcome:

6MWT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

BODE指数

指标类型:

次要指标 

Outcome:

BODE

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性指标

指标类型:

次要指标 

Outcome:

Safety

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:

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 85 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):

广东省中医院临床研究方法学团队研制中央随机分配管理系统,采用区组随机方法,通过SAS程序生成随机序列。

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

The central randomization management system developed by the Key Unit of Methodology in Clinical Research of Guangdong Province Hospital of Chinese Medical, and the randomization sequence will be generated by SAS software using block randomization method.

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):

研究报告

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

Research report

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:

病例记录表采集数据,并采用SPSS等软件保存和处理数据。

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

The data will be collected from the case record form and saved and processed by SPSS and other software.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-11-30
返回列表