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三黄固本止咳中药治疗慢性阻塞性肺疾病稳定期患者有效性和安全性的随机、双盲、安慰剂平行对照临床研究
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注册号:

Registration number:

ChiCTR1800016349 

最近更新日期:

Date of Last Refreshed on:

2018-05-26 

注册时间:

Date of Registration:

2018-05-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

三黄固本止咳中药治疗慢性阻塞性肺疾病稳定期患者有效性和安全性的随机、双盲、安慰剂平行对照临床研究 

Public title:

SAN HUAN GU BEN ZHI KE Granule for treatment of COPD stabilization: a randomized, double-blind, placebo-controlled parallel clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

固本止咳中药治疗慢性阻塞性肺疾病稳定期临床疗效评价研究 

Scientific title:

Clinical effect evaluation of GU BEN ZHI KE Granule on patients with stable 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:

李得民 

研究负责人:

李得民 

Applicant:

LI Demin 

Study leader:

LI Demin 

申请注册联系人电话:

Applicant telephone:

+86 13811830348 

研究负责人电话:

Study leader's telephone:

+86 13811830348 

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:

deminli2008@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

deminli2008@sina.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:

100029 

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:

2018-57-K41-1 

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:

2018-05-15 

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:

首都卫生发展科研专项项目 

Source(s) of funding:

Capital’s Funds for Health Improvement and Research  

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:

其它 

Study phase:

N/A 

研究目的:

以急性发作次数为主要结局指标,评价三黄固本止咳中药对COPD稳定期患者治疗的有效性和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of SAN HUAN GU BEN ZHI KE Granule in the treatment of stable COPD patients with acute attack times as the main outcome indicators. 

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)符合慢性阻塞性肺疾病(COPD)诊断标准; (2)近4周病情稳定,无急性加重; (3)COPD急性加重风险评估为高风险(在过去1年中急性加重次数≥2次或上一年因急性加重住院≥1次); (4)中医辨证为肺脾气虚证; (5)年龄在40~80岁之间,性别不限; (6)自愿参加研究并签署知情同意书。 

Inclusion criteria

1. Patients with COPD in stable period; 2. In the last 4 weeks, the condition was stable and no acute aggravation was found; 3. COPD acute exacerbation risk assessment is high risk(In the past 1 years, the number of acute exacerbations was more than 2 times, or the number of hospitalized patients was 1 times more than that of the previous year because of acute exacerbation); 4. Patients with lung and spleen qi deficiency; 5. Aged between 40 and 80 years, and the sex is not limited.; 6. Volunteer to accept treatment and sign the informed consent.  

排除标准:

(1)目前或近4周内患有肺炎和(或)中度或重度慢阻肺急性加重者; (2)既往行肺切除术,或筛选前12个月内接受肺减容手术者; (3)使用长期氧疗(氧疗时间>15h/d)或机械通气者; (4)伴有哮喘、活动性结核病、肺癌、支气管扩张症、肺栓塞、肺心病、肺间质性疾病或其他活动性疾病者; (5)下肢活动受限难以完成6分钟步行试验; (6)患有严重的高血压、糖尿病、肿瘤,原发性心、肝、肾、血液系统疾病控制不理想者; (7)肾脏Scr超过参考值上限1.5倍, 或肝功能检查AST、ALT≥2倍参考值上限者; (8)患有先天或获得性免疫缺陷型疾病者; (9)已知或疑似酒精或药物滥用史者; (10)有精神病史、智力缺陷、行动不便或其他将限制参与本研究知情同意有效性者; (11)妊娠或哺乳期女性或计划在研究期间妊娠者; (12)对研究药物成分过敏者; (13)目前规范使用口服糖皮质激素者; (14)近3个月内参加过其他临床试验者; (15)研究者认为不适宜参加临床试验者。 

Exclusion criteria:

1. At present or within 4 weeks, pneumonia and / or moderate or severe chronic obstructive pulmonary disease are more acute; 2. Previous lung resection or lung volume reduction surgery within the first 12 months of screening; 3. Using long term oxygen therapy (oxygen therapy time >15h/d) or mechanical ventilation; 4. Patients with asthma, active tuberculosis, lung cancer, bronchiectasis, pulmonary embolism, pulmonary heart disease, interstitial lung disease or other active diseases; 5. The 6 minute walk test is difficult to complete the limited movement of the lower limbs; 6. Suffering from severe hypertension, diabetes, tumor, primary heart, liver, kidney, blood system disease control is not ideal; 7. The renal Scr exceeds the limit of reference value by 1.5 times, or the upper limit of reference value of liver function tests AST or ALT is more than 2 times; 8. Patients with congenital or acquired immunodeficiency disease; 9. Patients known or suspected of alcohol or drug abuse; 10. Patients with mental illness, mental retardation, mobility problems or other restrictions that will restrict the effectiveness of informed consent in this study; 11. Pregnant or lactating women or those who plan to be pregnant during the study period; 12. Allergy to drug components; 13. Patients who use oral glucocorticoids at present; 14. Patient who attend other clinical trials in the last 3 months; 15. Researchers believe that it is not appropriate to participate in clinical trials. 

研究实施时间:

Study execute time:

From2018-01-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2018-06-01To 2019-10-31 

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

experimental group

Sample size:

干预措施:

三黄固本止咳中药

干预措施代码:

Intervention:

SAN HUAN GU BEN ZHI KE Granule

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

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):

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 

测量指标:

Outcomes:

指标中文名:

AECOPD 发生次数

指标类型:

主要指标 

Outcome:

Number of AECOPD occurrences

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

AECOPD情况:治疗后首次发生时间、每次间隔时间、持续时间、严重程度等;

指标类型:

次要指标 

Outcome:

AECOPD: after treatment for the first time, time interval, duration and severity;

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候积分

指标类型:

次要指标 

Outcome:

TCM syndrome scores

Type:

Secondary 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(FEV1、FVC、MMEF、FEF)

指标类型:

次要指标 

Outcome:

pulmonary function test (FEV1, FVC, MMEF, FEF)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

症状评估:mMRC

指标类型:

次要指标 

Outcome:

Symptom assessment: 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:

生活质量:CAT

指标类型:

次要指标 

Outcome:

Quality of life: CAT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动能力:6分钟步行距离

指标类型:

次要指标 

Outcome:

Exercise ability: 6 minutes walk distance

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指数评分

指标类型:

次要指标 

Outcome:

BODE index scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

合并用药情况

指标类型:

次要指标 

Outcome:

Combined use of drugs

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:全因死亡率、慢阻肺病死率

指标类型:

次要指标 

Outcome:

Mortality: death rate of all causes, chronic obstructive pulmonary disease

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:

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:

正在进行

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):

本网络平台 http://www.chictr.org.cn/

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

http://www.chictr.org.cn/

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-05-26
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