小青龙加杏仁石膏汤中药配方颗粒剂与传统饮片水煎剂干预AECOPD的疗效对比及量效关系研究

注册号:

Registration number:

ITMCTR2024000566

最近更新日期:

Date of Last Refreshed on:

2024-10-16

注册时间:

Date of Registration:

2024-10-16

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

小青龙加杏仁石膏汤中药配方颗粒剂与传统饮片水煎剂干预AECOPD的疗效对比及量效关系研究

Public title:

Comparative Study on the Efficacy and Dose-Effect Relationship of Xiao Qinglong Decoction with Xingren and Shigao Granules versus Traditional Decoction in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

注册题目简写:

English Acronym:

研究课题的正式科学名称:

小青龙加杏仁石膏汤中药配方颗粒剂与传统饮片水煎剂干预AECOPD的疗效对比及量效关系研究

Scientific title:

Comparative Study on the Efficacy and Dose-Effect Relationship of Xiao Qinglong Decoction with Xingren and Shigao Granules versus Traditional Decoction in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

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:

申请注册联系人:

丁鹏

研究负责人:

高培阳

Applicant:

ding peng

Study leader:

gao peiyang

申请注册联系人电话:

Applicant telephone:

18380456616

研究负责人电话:

Study leader's telephone:

18980025566

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:

dinglq1021@163.com

研究负责人电子邮件:

Study leader's E-mail:

gaopy930@126.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:

四川省成都市十二桥路39号

研究负责人通讯地址:

四川省成都市十二桥路39号

Applicant address:

No. 39 Shierqiao Road Chengdu Sichuan Province

Study leader's address:

No. 39 Shierqiao Road Chengdu Sichuan Province

申请注册联系人邮政编码:

Applicant postcode:

610072

研究负责人邮政编码:

Study leader's postcode:

610072

申请人所在单位:

成都中医药大学附属医院

Applicant's institution:

Hospital of Chengdu 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:

2024KL-136

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

成都中医药大学附属医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of the Hospital of Chengdu University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/10/12 0:00:00

伦理委员会联系人:

王艳桥

Contact Name of the ethic committee:

wang yanqiao

伦理委员会联系地址:

四川省成都市十二桥路39号

Contact Address of the ethic committee:

No. 39 Shierqiao Road Chengdu Sichuan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

028-87783139

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ethicscd@126.com

研究实施负责(组长)单位:

成都中医药大学附属医院

Primary sponsor:

Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

四川省成都市十二桥路39号

Primary sponsor's address:

No. 39 Shierqiao Road Chengdu Sichuan Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学附属医院

具体地址:

四川省成都市十二桥路39号

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Address:

No. 39 Shierqiao Road Chengdu Sichuan Province

经费或物资来源:

国家中医药管理局人才交流中心

Source(s) of funding:

Talent Exchange Center of the State Administration of Traditional Chinese Medicine

研究疾病:

AECOPD

研究疾病代码:

Target disease:

AECOPD

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:

其它

Others

研究目的:

探索小青龙加杏仁石膏汤中药配方颗粒与传统饮片治疗AECOPD的临床疗效差异,以及不同剂量中药配方颗粒的量效关系。

Objectives of Study:

To explore the differences in clinical efficacy between Xiao Qinglong plus Xingren Shigao Decoction granules and traditional decoction pieces in the treatment of AECOPD as well as the dose-effect relationship of different doses of Chinese medicine formula granules.

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)40 岁≤年龄≤80 岁; (2)符合上述AECOPD(无呼吸衰竭)的诊断标准; (3)须住院治疗且在发病后48小时内入院; (4)入院时呼吸困难、咳嗽和痰量表(Breathlessness, Cough and Sputum Scale,BCSS)评分≥6分; (5)签署知情同意书。

Inclusion criteria

(1) Age between 40 and 80 years; (2) Meets the diagnostic criteria for the aforementioned AECOPD (without respiratory failure); (3) Requires hospitalization and is admitted within 48 hours of onset; (4) Breathlessness Cough and Sputum Scale (BCSS) score of ≥6 upon admission; (5) Signed informed consent.

排除标准:

(1)休克或其他血液动力学不稳定; (2)需机械通气治疗; (3)合并活动性肺结核、肺癌(确诊或疑似)、肺脓肿; (4)合并严重的肺部器质性病变(如重度支气管扩张、严重肺纤维化/囊性纤维化/间质疾病、重度肺动脉高压、严重闭塞性细支气管炎等)或其他活动性肺部疾病; (5)既往肺切除病史,或过去 12 个月内接受肺减容术; (6)在研究期间进行肺康复者; (7)严重心脏病史,如急性心肌梗死、充血性心力衰竭(NYHA级别III及以上)、严重心律失常和其他急性心脏病; (8)重要器官和系统的严重原发疾病,如急性中风、治疗后高度高血压、活动性胃溃疡、糖尿病(严重并发症)、恶性肿瘤等; (9)活动性甲型肝炎、乙型肝炎、HIV、结核病和传染性结缔组织疾病; (10)严重肝肾功能障碍者; (11)怀疑或已确认有酒精或药物滥用史; (12)有精神障碍及智力障碍,或治疗依从性差; (13)妊娠或哺乳期女性,或计划在研究期间妊娠的女性; (14)已知对任何研究药物成分有过敏或超敏反应史,或被研究医师认为已知患有应禁止使用参加研究药物的疾病; (15)过去30天内接受过任何试验用药品治疗或与本研究用药类似中药/中成药; (16)已参加过本研究; (17)研究者认为不适合参与本研究。

Exclusion criteria:

(1) Shock or other hemodynamic instability; (2) Requires mechanical ventilation; (3) Concurrent active pulmonary tuberculosis lung cancer (confirmed or suspected) lung abscess; (4) Concurrent severe pulmonary organic lesions (e.g. severe bronchiectasis severe pulmonary fibrosis/cystic fibrosis/interstitial disease severe pulmonary hypertension severe obliterative bronchiolitis etc.) or other active pulmonary diseases; (5) History of lung resection or lung volume reduction surgery in the past 12 months; (6) Undergoing pulmonary rehabilitation during the study; (7) Severe heart disease history such as acute myocardial infarction congestive heart failure (NYHA class III and above) severe arrhythmia and other acute cardiac diseases; (8) Severe primary diseases of important organs and systems such as acute stroke poorly controlled hypertension active peptic ulcer diabetes (with severe complications) malignant tumors etc.; (9) Active hepatitis A hepatitis B HIV tuberculosis and infectious connective

研究实施时间:

Study execute time:

From 2024-03-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2024-10-25

To      2025-12-31

干预措施:

Interventions:

组别:

中剂量配方颗粒组(75%标准剂量)

样本量:

64

Group:

Medium dosage granule group (75% of the standard dosage)

Sample size:

干预措施:

在西医常规治疗的基础上,加用中剂量(75%标准剂量)的配方颗粒

干预措施代码:

Intervention:

On the basis of conventional Western medical treatment add medium dosage (75% of the standard dosage) formula granules.

Intervention code:

组别:

传统饮片组

样本量:

64

Group:

Traditional decoction pieces group

Sample size:

干预措施:

西医常规治疗的基础上,加用中药饮片(小青龙加杏仁石膏汤)水煎剂

干预措施代码:

Intervention:

On the basis of conventional Western medical treatment an additional Chinese herbal decoction (Xiao Qing Long Jia Xing Ren Shi Gao Tang) is administered.

Intervention code:

组别:

等价格配方颗粒组(33%标准剂量)

样本量:

64

Group:

Same-price granule group (33% of the standard dosage)

Sample size:

干预措施:

在西医常规治疗的基础上,加用与中药饮片(小青龙加杏仁石膏汤33%标准剂量)等价格的配方颗粒

干预措施代码:

Intervention:

On the basis of conventional Western medical treatment add formula granules priced equivalent to the Chinese herbal decoction (Minor Blue Dragon Decoction with Apricot Kernel and Gypsum at 33% of the standard dosage).

Intervention code:

组别:

安慰剂组

样本量:

64

Group:

Placebo group

Sample size:

干预措施:

在西医常规治疗的基础上,加用中药配方颗粒模拟剂

干预措施代码:

Intervention:

On the basis of conventional Western medical treatment add a placebo of Chinese herbal formula granules.

Intervention code:

组别:

标准剂量配方颗粒组

样本量:

64

Group:

Standard dosage granule group

Sample size:

干预措施:

在西医常规治疗的基础上,加用与中药饮片(小青龙加杏仁石膏汤)等剂量的配方颗粒

干预措施代码:

Intervention:

On the basis of conventional Western medical treatment add formula granules equivalent in dosage to the Chinese herbal decoction pieces (Xiao Qing Long Jia Xing Ren Shi Gao Tang).

Intervention code:

样本总量 Total sample size : 320

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

重庆

市(区县):

重庆

Country:

China

Province:

chongqing

City:

chongqing

单位(医院):

重庆市中医院

单位级别:

三级甲等

Institution/hospital:

Chongqing Traditional Chinese Medicine Hospital

Level of the institution:

Tier 3 Class A

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学附属医院

单位级别:

三级甲等

Institution/hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution:

Tier 3 Class A

国家:

中国

省(直辖市):

新疆新疆维吾尔自治区

市(区县):

乌鲁木齐

Country:

中国

Province:

新疆维吾尔自治区

City:

乌鲁木齐

单位(医院):

新疆维吾尔自治区中医医院

单位级别:

三级甲等

Institution/hospital:

新疆维吾尔自治区中医院

Level of the institution:

Tier 3 Class A

测量指标:

Outcomes:

指标中文名:

30天、90天和180天肺功能指标(FVC、FEV1、FEV1/FVC)

指标类型:

次要指标

Outcome:

Pulmonary function indicators at 30 90 and 180 days (FVC FEV1 FEV1/FVC)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天、90天和180天内的无住院天数

指标类型:

次要指标

Outcome:

Days without hospitalization within 30 90 and 180 days

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第11天、30天、90天和180天BCSS评分

指标类型:

次要指标

Outcome:

Day 11 30 90 and 180 BCSS 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:

住院时间、ICU住院时间

指标类型:

次要指标

Outcome:

Length of hospital stay and ICU stay duration

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分钟步行试验(6MWT)

指标类型:

次要指标

Outcome:

6-minute walk test (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:

从入组到与 COPD 急性加重相关症状和体征消失的时间

指标类型:

主要指标

Outcome:

SRT

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院后至下一次急性加重发生间隔天数

指标类型:

次要指标

Outcome:

Number of days between discharge and the next acute 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:

180天内急性加重再发生次数

指标类型:

次要指标

Outcome:

Number of acute exacerbation recurrences within 180 days

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首次住院未服用中药时间

指标类型:

次要指标

Outcome:

Time not taking traditional Chinese medicine during the first hospitalization

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:

粪便

组织:

Sample Name:

faeces

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:

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:

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):

采用中央随机系统,进行区组随机化;随机化列表由计算机生成,其中有不同大小的区块。初始各试验组随机比例为1:1:1:1:1,并根据预设的中期分析,调整随机入组方案。

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

A central randomization system was used to perform block randomization. The randomization list was computer-generated with blocks of varying sizes. Initially the randomization ratio for each trial group was 1:1:1:1:1 and the randomization scheme was adjusted based on predetermined interim analyses.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

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

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:

电子采集和管理系统(EDC)

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

Electronic Data Capture

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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