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Clinical study of pediatric spleen and lung clearing prescription in the treatment of pulmonary and spleen dampness and heat syndrome in children with cough and asthma

注册号：

Registration number：

ITMCTR2024000701

最近更新日期：

Date of Last Refreshed on：

2024-11-13

注册时间：

Date of Registration：

2024-11-13

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

小儿健脾清肺方治疗小儿咳嗽病肺脾湿热证的临床研究

Public title：

Clinical study of pediatric spleen and lung clearing prescription in the treatment of pulmonary and spleen dampness and heat syndrome in children with cough and asthma

注册题目简写：

小儿健脾清肺治疗小儿咳嗽

English Acronym：

研究课题的正式科学名称：

小儿健脾清肺方治疗小儿咳嗽病肺脾湿热证的临床研究

Scientific title：

Clinical study of pediatric spleen and lung clearing prescription in the treatment of pulmonary and spleen dampness and heat syndrome in children with cough and asthma

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：

田雯

研究负责人：

谷晓红

Applicant：

Wen Tian

Study leader：

Xiaohong Gu

申请注册联系人电话：

Applicant telephone：

18229973190

研究负责人电话：

Study leader's telephone：

01064286998

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：

tianwen0492@163.com

研究负责人电子邮件：

Study leader's E-mail：

guxiaohong1962@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：

陕西省铜川市耀州区长虹北路26号

研究负责人通讯地址：

北京市朝阳区北三环东路11号

Applicant address：

No. 26 Changhong North Road Yaozhou District Tongchuan City Shaanxi Province

Study leader's address：

No. 11 North Third Ring East Road Chaoyang District Beijing

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：

北京中医药大学

Applicant's institution：

Beijing University of 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：

SSMYY-KYPJ-2024-057

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：

北京中医药大学孙思邈医院伦理委员会

Name of the ethic committee：

Ethics Committee of Sun Simiao Hospital Beijing University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/6/25 0:00:00

伦理委员会联系人：

曹静

Contact Name of the ethic committee：

Jing Cao

伦理委员会联系地址：

陕西省铜川市耀州区长虹北路26号

Contact Address of the ethic committee：

No. 26 Changhong North Road Yaozhou District Tongchuan City Shaanxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

09198181203

伦理委员会联系人邮箱：

Contact email of the ethic committee：

bzykjb@163.com

研究实施负责（组长）单位：

北京中医药大学孙思邈医院

Primary sponsor：

Sun Simiao Hospital Beijing University of Chinese Medicine

研究实施负责（组长）单位地址：

陕西省铜川市耀州区长虹北路26号

Primary sponsor's address：

No. 26 Changhong North Road Yaozhou District Tongchuan City Shaanxi 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)：

陕西

市(区县)：

铜川

Country：

China

Province：

Shaanxi

City：

Tongchuan

单位(医院)：

北京中医药大学孙思邈医院

具体地址：

陕西省铜川市耀州区长虹北路26号

Institution
hospital：

Sun Simiao Hospital Beijing University of Chinese Medicine

Address：

No. 26 Changhong North Road Yaozhou District Tongchuan City Shaanxi Province

经费或物资来源：

自筹经费

Source(s) of funding：

Self-funded

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：

半随机对照

Quasi-randomized controlled

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

儿童急性支气管炎好发属于常见呼吸道系统疾病。本研究基于肺胃肠同治理论，对儿童辨证为肺脾湿热的小儿咳嗽病在北京中医药大学孙思邈医院住院的患者纳入分析。对咳嗽肺脾湿热证患儿进行随机分组，以 1:1 将研究对象分为试验组和对照组，对照组患者运用常规抗病毒、抗细菌、补液、维持电解质等对症支持治疗；试验组患者在常规西医治疗下，同步予以小儿健脾方治疗。进入试验组的患者家属可以根据意愿选择试验组或者对照组的干预方案。通过比较两组患儿咳嗽病转归，肺系外感病复感情况，探索小儿健脾方治疗咳嗽病肺脾湿热证患儿的有效性和安全性

Objectives of Study：

Acute bronchitis in children is a common respiratory disease. Based on the theory of pulmonary and gastrointestinal co-treatment this study included and analyzed the inpatients hospitalized in Sun Simiao Hospital of Beijing University of Chinese Medicine for pediatric cough disease with pulmonary and spleen dampness and fever. Children with cough lung spleen damp and heat syndrome were randomly divided and the study subjects were divided into the experimental group and the control group at a ratio of 1:1 and the patients in the control group were treated with conventional antiviral antibacterial rehydration electrolyte maintenance and other symptomatic supportive treatments. The patients in the experimental group were treated with pediatric spleen formula under conventional Western medicine treatment. The family members of patients who enter the experimental group can choose the intervention plan of the experimental group or the control group according to their wishes. By comparing the prognosis of cough disease and the recurrence of extrapulmonary infection in the two groups the effectiveness and safety of pediatric spleen strengthening formula in the treatment of children with cough disease lung and spleen dampness and heat syndrome were explored.

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. 1 周岁≤年龄≤14 周岁儿童； 2. 符合肺脾湿热证的急性支气管炎患者。①西医诊断标准：参照 《诸福棠实用儿科学》第 9 版急性支气管炎诊断。②中医诊断：根据《中医儿科病常见诊疗指南》《中医临床诊疗术第 2 部分·证候》为标准，中医疾病诊断参考“咳嗽”。 3 法定监护人签署知情同意书，自愿参加本项研究者。

Inclusion criteria

1. Children aged 1 ≤ ≤ 14 years old; 2. Patients with acute bronchitis who meet the pulmonary and spleen damp-heat syndrome. (1) Diagnostic criteria of Western medicine: refer to the diagnosis of acute bronchitis in the 9th edition of "Zhufutang Practical Pediatrics". (2) TCM diagnosis: According to the "Guidelines for Common Diagnosis and Treatment of Pediatric Diseases in TCM" and "TCM Clinical Diagnosis and Treatment Part 2 · Syndromes" as the standard the diagnosis of TCM diseases refers to "cough". 3. The legal guardian signed the informed consent form and voluntarily participated in this study.

排除标准：

①合并先天性心脏病、支气管肺发育不良、呼吸道畸形、肺部肿瘤、肺结核、脑发育不良、神经和肌肉疾病、慢性肝肾疾病和造血系统疾病等； ②原发性自身免疫缺陷或急性传染病患者； ③既往严重过敏或哮喘史病史患儿或对本研究中使用的药物过敏； ④唐氏综合症、18 三体综合征、苯丙酮尿症、青少年糖尿病等遗传病患儿； ⑤经积极治疗，病情无好转，病程超过 1 周的重症患儿； ⑥最近 3 个月内曾参加或正在参加其他药物临床试验的患者。

Exclusion criteria：

(1) Combined with congenital heart disease bronchopulmonary dysplasia respiratory malformations lung tumors tuberculosis brain dysplasia neurological and muscular diseases chronic liver and kidney diseases hematopoietic diseases etc.; (2) Patients with primary autoimmune deficiency or acute infectious diseases; (3) Children with a history of severe allergies or asthma in the past or allergies to the drugs used in this study; (4) Children with genetic diseases such as Down syndrome trisomy 18 phenylketonuria and juvenile diabetes; (5) After active treatment the condition does not improve and the course of the disease is more than 1 week; (6) Patients who have participated in or are participating in other drug clinical trials within the last 3 months.

研究实施时间：

Study execute time：

从From 2024-07-01

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2024-07-01

至To      2025-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

95

Group：

Control group

Sample size：

干预措施：

辨证为肺脾湿热证的小儿咳嗽病患者，予以常规西医的抗病毒、 抗细菌、退热、补液等对症支持治疗 5-7 天

干预措施代码：

Intervention：

Pediatric patients with cough syndrome with lung-spleen damp-heat syndrome are treated with symptomatic supportive treatment such as antiviral, antibacterial, antipyretic, and rehydration by conventional Western medicine for 5-7 days

Intervention code：

组别：

试验组

样本量：

95

Group：

Experimental group

Sample size：

干预措施：

辨证为肺脾湿热证的小儿咳嗽患者，除常规西医的抗病毒、 抗细菌、退热、补液等对症支持治疗外，辅助小儿健脾清肺方5-7天

干预措施代码：

Intervention：

In addition to the symptomatic supportive treatment of antiviral antibacterial antipyretic and fluid rehydration of conventional Western medicine pediatric cough patients with lung dampness syndrome will be assisted for 5-7 days

Intervention code：

样本总量 Total sample size ： 190

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

陕西

市(区县)：

铜川

Country：

China

Province：

shaan

City：

Tongchuan

单位(医院)：

北京中医药大学孙思邈医院

单位级别：

三甲

Institution/hospital：

Sun Simiao Hospital, Beijing University of Chinese Medicine

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

住院期间实验室检查

指标类型：

主要指标

Outcome：

Laboratory tests during hospitalization

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

出院转归

指标类型：

次要指标

Outcome：

Outcome of hospital discharge

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者症状体征变化评分

指标类型：

主要指标

Outcome：

Patient symptom and sign change score

Type：

Primary 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：

检验科剩余尿样本

组织：

Sample Name：

Remaining urine sample from the laboratory department

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：

检验科剩余血样本

组织：

Sample Name：

Remaining blood sample from the laboratory department

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：

检验科剩余便样本

组织：

Sample Name：

Remaining stool sample from the laboratory department

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：

正在进行

Recruiting

年龄范围：

最小 1 岁
Min age years
最大 14 岁
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）：

由专业技术人员通过SPSS程序随机生成序列号。根据Zelen's设计，进入试验组的患者可以根据自身意愿选择是否接受中医治疗，若不接受直接进入对照组

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

Serial numbers are randomly generated by professional technicians through the SPSS procedure. According to Zelen's design patients who enter the trial group can choose whether to receive TCM treatment according to their own wishes and if they do not they can directly enter the control group

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

否

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）：

不共享原始数据

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

Not share the original data.

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：

由专人培训后，对患者的所有资料采用标准CRF表进行记录，采集患者的一般资料。包括患者的人口学信息，出生信息等，患者的症状评分进行详细记录，患者的实验检查结果，出院日期、出院转归均进行详细记录。整理的CRF表收集后录入电子系统，采用Excel整理数据，SPSS、R语言等统计软件进行分析

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

After being trained by a special person all the patient's data are recorded using a standard CRF form and the patient's general information is collected. Including the patient's demographic information birth information etc. the patient's symptom score is recorded in detail the patient's experimental examination results discharge date and discharge outcome are recorded in detail. The CRF form is entered into the electronic system and the data is sorted out by Excel and analyzed by statistical software such as SPSS and R language.

数据管理委员会：

Data Managemen Committee：

有

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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