清咳平喘颗粒治疗儿童急性支气管炎(痰热郁肺证)的随机、双盲、极低剂量试验药物平行对照、多中心、III期临床试验

注册号:

Registration number:

ITMCTR2025001440

最近更新日期:

Date of Last Refreshed on:

2025-07-20

注册时间:

Date of Registration:

2025-07-20

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

清咳平喘颗粒治疗儿童急性支气管炎(痰热郁肺证)的随机、双盲、极低剂量试验药物平行对照、多中心、III期临床试验

Public title:

A randomized double-blind very low dose trial of Qingke Pingchuan Granules in the treatment of acute bronchitis (phlegm-heat stagnation lung syndrome) in children a multi-center phase III clinical trial

注册题目简写:

清咳平喘颗粒治疗儿童急性支气管炎(痰热郁肺证)的III期临床试验

English Acronym:

Phase III clinical trial of Qingke Pingchuan Granules treating acute bronchitis (phlegm-heat syndrome of stagnation of lung) in children

研究课题的正式科学名称:

清咳平喘颗粒治疗儿童急性支气管炎(痰热郁肺证)的随机、双盲、极低剂量试验药物平行对照、多中心、III期临床试验

Scientific title:

A randomized double-blind very low dose trial of Qingke Pingchuan Granules in the treatment of acute bronchitis (phlegm-heat stagnation lung syndrome) in children a multi-center phase III clinical trial

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:

王晴

研究负责人:

任献青

Applicant:

Wang Qing

Study leader:

Ren Xianqing

申请注册联系人电话:

Applicant telephone:

+86 188 5109 3212

研究负责人电话:

Study leader's telephone:

+86 136 7371 2698

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:

wangqing@lys.cn

研究负责人电子邮件:

Study leader's E-mail:

13673712698@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:

吉林省长春市前进大街火炬路833号

研究负责人通讯地址:

河南省郑州市人民路19号

Applicant address:

833 Torch Road Qianjin Street Changchun City Jilin Province

Study leader's address:

19 Renmin Road Zhengzhou City Henan Province

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:

长春雷允上药业有限公司

Applicant's institution:

Changchun Lei Yun on pharmaceutical Co. LTD

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:

2024HL-404

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:

河南中医药大学第一附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Henan University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/9/12 0:00:00

伦理委员会联系人:

吴涛

Contact Name of the ethic committee:

Wu Tao

伦理委员会联系地址:

河南省郑州市人民路19号

Contact Address of the ethic committee:

19 Renmin Road Zhengzhou City Henan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

037166285929

伦理委员会联系人邮箱:

Contact email of the ethic committee:

renxq723@163.com

研究实施负责(组长)单位:

河南中医药大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of Henan University of Chinese Medicine

研究实施负责(组长)单位地址:

河南省郑州市人民路19号

Primary sponsor's address:

19 Renmin Road Zhengzhou City Henan 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):

吉林

市(区县):

长春

Country:

China

Province:

Jilin

City:

Changchun

单位(医院):

长春雷允上药业有限公司

具体地址:

吉林省长春市前进大街火炬路833号

Institution
hospital:

Changchun Lei Yun on pharmaceutical Co. LTD

Address:

833 Torch Road Qianjin Street Changchun City Jilin Province

经费或物资来源:

自筹

Source(s) of funding:

self-raised

研究疾病:

急性支气管炎

研究疾病代码:

Target disease:

Acute bronchitis

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:

III期临床试验

Phase III clinical trial

研究目的:

以极低剂量试验药物为对照,评价清咳平喘颗粒治疗儿童急性支气管炎(痰热郁肺证)的有效性和安全性。 以极低剂量试验药物为对照,评价清咳平喘颗粒治疗儿童急性支气管炎(痰热郁肺证)患者在缓解支气管炎病情/症状体征、改善中医证候作用。

Objectives of Study:

To evaluate the efficacy and safety of Qingke Pingchuan granules in the treatment of acute bronchitis in children (phlegm-heat syndrome of stagnation of lung). To evaluate the effect of Qingke Pingchuan Granules on relieving bronchitis condition/symptoms and improving TCM syndromes in treating children with acute bronchitis (phlegm-heat syndrome of stagnation of lung).

药物成份或治疗方案详述:

试验药:清咳平喘颗粒,规格:6g/袋、8g/袋,由长春雷允上药业有限公司提供。 对照药:极低剂量清咳平喘颗粒(含10%清咳平喘颗粒),6g/袋(10%原药含量)、8g/袋(10%原药含量),与清咳平喘颗粒试验药颜色、气味、外观基本一致,由长春雷允上药业有限公司提供。

Description for medicine or protocol of treatment in detail:

Experimental drug: Qingke Pingchuan granules specifications: 6g/ bag 8g/ bag provided by Changchunlei Yunshang Pharmaceutical Co. LTD. Experimental drug: Qingke Pingchuan granules specification: 6g/ bag control drug: very low dose Qingke Pingchuan granules (containing 10% Qingke Pingchuan granules) 6g/ bag (10% active drug content) 8g/ bag (10% active drug content) basically consistent with the color smell and appearance of Qingke Pingchuan granules provided by Changchunlei Yunshang Pharmaceutical Co. LTD.

纳入标准:

(1)符合儿童急性支气管炎西医诊断标准; (2)中医辨证为痰热郁肺证; (3)6周岁≤年龄≤14周岁,性别不限; (4)病程≤48小时; 病程:从出现急性支气管炎症状(咳嗽、咳痰、肺部啰音、咳时胸痛、呼吸困难)起至随机入组的时间。 (5)支气管炎严重程度评分(BSS)≥5分; (6)咳嗽症状积分日间或夜间≥2分; (7)法定监护人或与≥8周岁受试儿童知情同意并签署知情同意书。

Inclusion criteria

(1) Meet the Western diagnostic criteria for acute bronchitis in children; (2) TCM syndrome differentiation is phlegm-heat stagnation lung syndrome; (3) 6 years old ≤ age ≤14 years old gender is not limited; (4) Duration ≤48 hours; Course of disease: From the onset of symptoms of acute bronchitis (cough phlegm lung rales chest pain with cough dyspnea) to the time of random admission. (5) Bronchitis severity score (BSS) >=5 points; (6) Cough symptom score >=2 points during the day or at night; (7) Legal guardian or children >=8 years old informed consent and signed informed consent.

排除标准:

(1)重症支气管炎与肺炎早期难以鉴别者; (2)患有麻疹、百日咳、流行性感冒等急性传染病; (3)患有急性上呼吸道感染、化脓性扁桃体炎、急性感染性喉炎、毛细支气管炎、支气管肺炎、肺脓肿、肺结核、新冠感染等其他呼吸道疾病患儿; (4)患有支气管哮喘、多因素诱发的婴幼儿哮喘及哮喘预测指数阳性患儿; (5)慢性支气管炎急性发作患儿; (6)血白细胞总数>12×10^9/L,中性粒细胞百分比>70%,且经研究者判断确定为细菌感染者; (7)营养不良、免疫缺陷患儿; (8)筛选时及筛选前24h体温(腋温)超过38.0℃或既往一年内出现过高热惊厥的患儿; (9)肝功能检测值(ALT、AST)>1.5倍正常值上限,血肌酐(Scr)>正常值上限; (10)对试验用药品或其成分过敏者; (11)筛选前24h内曾使用抗生素、止咳化痰药等对咳嗽有影响的中西药物的患儿; (12)合并严重心、肝、肾、消化及造血系统等严重原发病; (13)筛选前3个月参加其他干预性临床试验的; (14)研究者认为不宜参与本试验的其它情况

Exclusion criteria:

(1) severe bronchitis and pneumonia are difficult to distinguish in early stage; (2) suffering from acute infectious diseases such as measles whooping cough and influenza; (3) Children with acute upper respiratory tract infection suppurative tonsillitis acute infectious laryngitis bronchiolitis bronchoppneumonia pulmonary abscess tuberculosis COVID-19 infection and other respiratory tract diseases; (4) Children with bronchial asthma multi-factor induced asthma and positive asthma prediction index; (5) Children with acute onset of chronic bronchitis; (6) The total number of white blood cells was > 12×10^9/L the percentage of neutrophil was > 70% and the investigators determined that the bacteria were infected; (7) Children with malnutrition and immune deficiency; (8) Children with body temperature (axillary temperature) exceeding 38.0℃ at the time of screening and 24h before screening or with febrile convulsion within the previous year; (9) Liver function test values (ALT AST) > 1.5 times the upper limit of no

研究实施时间:

Study execute time:

From 2024-12-01

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2025-08-01

To      2026-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

120

Group:

Control group

Sample size:

干预措施:

极低剂量清咳平喘颗粒,6-9岁组:1袋(6g)/次,10-14岁组:1袋(8g)/次,开水冲服,一日3次。

干预措施代码:

Intervention:

Very low dose Qingke Pingchuan granules, 6-9 years old group: 1 bag (6g)/times, 10-14 years old group: 1 bag (8g)/times, taken with boiling water, 3 times a day.

Intervention code:

组别:

试验组

样本量:

360

Group:

Experimental group

Sample size:

干预措施:

清咳平喘颗粒,6-9岁组:1袋(6g)/次,10-14岁组:1袋(8g)/次,开水冲服,一日3次。

干预措施代码:

Intervention:

Qingke Pingchuan granules 6-9 years old group: 1 bag (6g)/times 10-14 years old group: 1 bag (8g)/times taken with boiling water 3 times a day.

Intervention code:

样本总量 Total sample size : 480

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

河南省

市(区县):

郑州市

Country:

China

Province:

Hnnan province

City:

Zhengzhou City

单位(医院):

河南中医药大学第一附属医院

单位级别:

三甲

Institution/hospital:

The First Affiliated Hospital of Henan University of Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省

市(区县):

中山市

Country:

China

Province:

Guangdong Province

City:

Zhongshan City

单位(医院):

中山市博爱医院(中山市妇幼保健院)

单位级别:

三甲

Institution/hospital:

Zhongshan Bo 'ai Hospital (Zhongshan Maternal and Child Health Hospital)

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei Province

City:

Wuhan City

单位(医院):

武汉市中心医院

单位级别:

三甲

Institution/hospital:

Wuhan Central Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei Province

City:

Wuhan City

单位(医院):

武汉儿童医院

单位级别:

三甲

Institution/hospital:

Wuhan Children's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

浙江省

市(区县):

杭州市

Country:

China

Province:

Zhejiang Province

City:

Hangzhou City

单位(医院):

浙江省中医院

单位级别:

三甲

Institution/hospital:

Zhejiang Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

江苏省

市(区县):

苏州市

Country:

China

Province:

Jiangsu Province

City:

单位(医院):

苏州大学附属儿童医院

单位级别:

三甲

Institution/hospital:

Children's Hospital of Soochow University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

天津市

市(区县):

天津市

Country:

China

Province:

Tianjin City

City:

Tianjin City

单位(医院):

天津市儿童医院

单位级别:

三甲

Institution/hospital:

Tianjin Children's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南省

市(区县):

郑州市

Country:

China

Province:

Henan province

City:

单位(医院):

河南省儿童医院郑州儿童医院

单位级别:

三甲

Institution/hospital:

Henan Children's Hospital Zhengzhou Children's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

吉林省

市(区县):

长春市

Country:

China

Province:

Jilin Province

City:

Changchun City

单位(医院):

长春中医药大学附属医院

单位级别:

三甲

Institution/hospital:

The Affiliated Hospital of Changchun University of Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东省

市(区县):

佛山市

Country:

China

Province:

Guangdong Province

City:

Foshan City

单位(医院):

佛山市妇幼保健院

单位级别:

三甲

Institution/hospital:

Foshan Maternal and Child Health Care Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南省

市(区县):

三门峡市

Country:

China

Province:

Henan province

City:

Sanmenxia City

单位(医院):

三门峡市中心医院

单位级别:

三甲

Institution/hospital:

Sanmenxia Central Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省

市(区县):

济南市

Country:

China

Province:

Shandong Province

City:

Jinan City

单位(医院):

山东中医药大学附属医院

单位级别:

三甲

Institution/hospital:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南省

市(区县):

郑州市

Country:

China

Province:

Henan Province

City:

单位(医院):

河南省中西医结合医院

单位级别:

三甲

Institution/hospital:

Henan Hospital of Integrated Chinese and Western Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南省

市(区县):

洛阳市

Country:

China

Province:

Hnnan province

City:

Luoyang City

单位(医院):

洛阳市第一人民医院

单位级别:

三甲

Institution/hospital:

Luoyang First People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河北省

市(区县):

石家庄市

Country:

China

Province:

Hebei Province

City:

Shijiazhuang City

单位(医院):

河北省中医院

单位级别:

三甲

Institution/hospital:

Hebei Provincial Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

福建省

市(区县):

厦门市

Country:

China

Province:

Fujian Province

City:

Xiamen City

单位(医院):

厦门市中医院

单位级别:

三甲

Institution/hospital:

Xiamen Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省

市(区县):

淄博市

Country:

China

Province:

Shandong Province

City:

Zibo City

单位(医院):

淄博市中医医院

单位级别:

三甲

Institution/hospital:

Zibo City Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山西省

市(区县):

咸阳市

Country:

China

Province:

Shaanxi Province

City:

Xianyang City

单位(医院):

陕西中医药大学第二附属医院

单位级别:

三甲

Institution/hospital:

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河南省

市(区县):

开封市

Country:

China

Province:

Hnnan province

City:

Kaifeng City

单位(医院):

河南大学第一附属医院

单位级别:

三甲

Institution/hospital:

The First Affiliated Hospital of Henan University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山西省

市(区县):

太原市

Country:

China

Province:

Shanxi Province

City:

Tiyuan City

单位(医院):

山西省儿童医院山西省妇幼保健院

单位级别:

三甲

Institution/hospital:

Shanxi Children's Hospital Shanxi Maternal and Child Health Care Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

疾病有效率:用药第5天达到疾病有效标准的受试者比例

指标类型:

主要指标

Outcome:

Proportion of subjects meeting disease efficacy criteria on day 5

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

试验期间应急用药使用量及使用次数

指标类型:

次要指标

Outcome:

Emergency drug use and times of use during the test

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药第3天、5天、7天咳嗽消失率

指标类型:

次要指标

Outcome:

The rate of cough disappearance on the 3rd, 5th and 7th day of medication

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药后疾病临床痊愈时间

指标类型:

次要指标

Outcome:

Clinical recovery time of the disease after medication

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药第5天、7天中医证候疗效评价(痊愈率、愈显率、总有效率)

指标类型:

次要指标

Outcome:

Evaluation of the curative effect of TCM syndromes on the 5th and 7th day of medication (recovery rate, apparent rate, total effective 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:

用药第5天、7天中医单项症状(咳嗽、咳痰、喉间痰鸣、气促/气喘、发热、咽痛、口渴、面赤、小便短赤、大便干结)消失率

指标类型:

次要指标

Outcome:

The disappearance rate of TCM single symptoms (cough, expectoration, phlegm in throat, shortness of breath/wheezing, fever, sore throat, thirst, red face, short red urine, dry stool) on the 5th and 7th day of medication

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药后咳嗽起效时间

指标类型:

次要指标

Outcome:

Onset time of cough relief after medication administration

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药第5天、7天单项主要症状(咳嗽、咳痰、肺部啰音、咳时胸痛、呼吸困难)消失率

指标类型:

次要指标

Outcome:

Disappearance rates of individual major symptoms (cough expectoration pulmonary rales chest pain during coughing dyspnea) on Day 5 and Day 7 of medication

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药后咳嗽消失时间

指标类型:

次要指标

Outcome:

Time for cough to disappear after medication

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

试验期间受试儿童肺炎发生率

指标类型:

次要指标

Outcome:

Incidence of pneumonia in children during the trial.

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药第5天、7天疾病临床痊愈率

指标类型:

次要指标

Outcome:

Clinical recovery rate on the 5th and 7th day of medication

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

试验期间抗生素的使用量及使用次数

指标类型:

次要指标

Outcome:

The amount and frequency of antibiotic use during the trial

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药后单项主要症状(咳嗽、咳痰、咳时胸痛、呼吸困难)消失时间

指标类型:

次要指标

Outcome:

Time of disappearance of the single major symptoms (cough, sputum, chest pain during cough, dyspnea) after medication

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

用药第7天达到疾病有效标准的受试者比例

指标类型:

次要指标

Outcome:

The disappearance rate of single major symptoms (cough, sputum, pulmonary rales, chest pain during cough, dyspnea) on the 5th and 7th day of medication

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:

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:

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 6
Min age years
最大 14
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):

由北京医云未来科技有限公司通过分层区组随机的方法产生序列

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

The sequence was generated by stratified block random method by Beijing Yiyun Future Technology Co. LTD

盲法:

本试验采用双盲设计(受试者与研究者均处于盲态)

Blinding:

Double-blind design was used in this study (both subjects and investigators were blind).

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):

不共享数据

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

Unshared dat

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:

采用EDC系统进行数据收集和管理

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

EDC system is used for data collection and management

数据管理委员会:

Data Managemen Committee:

No

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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