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Clinical study of Xiaoerjianpiqingfei Formula in the treatment of feipishire syndrome in children with pneumonia

注册号：

Registration number：

ITMCTR2024000694

最近更新日期：

Date of Last Refreshed on：

2024-11-12

注册时间：

Date of Registration：

2024-11-12

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肺炎喘嗽病肺脾湿热证的临床研究

Public title：

Clinical study of Xiaoerjianpiqingfei Formula in the treatment of feipishire syndrome in children with pneumonia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

小儿健脾清肺方治疗小儿肺炎喘嗽病肺脾湿热证的临床研究

Scientific title：

Clinical study of Xiaoerjianpiqingfei Formula in the treatment of feipishire syndrome in children with pneumonia

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-2024-056

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号北京中医药大学孙思邈医院南院区

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：

肺炎

研究疾病代码：

Target disease：

pneumonia

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：

小儿肺系外感病（如上呼吸道感染、支气管炎、肺炎等）是临床常见病、多发病，严重威胁儿童生命健康，呼吸道感染影响儿童成年后健康与寿命，加重社会医疗负担。谷晓红教授长期从事儿童外感性病防治研究，凝练出“胃肠积热”证态，胃肠积热常见的临床表现有食欲异常、大便干结、口臭、易汗、面赤、目眵、夜卧不安、舌质红、舌苔黄、脉数等。胃肠积热证态还可兼痰湿、兼气虚等兼夹证态。基于多年临床研究，谷晓红教授提出胃肠积热夹湿的小儿罹患肺炎喘嗽时，易加重内湿。经临床经验及前期的理论研究，谷晓红教授团队研发治疗小儿肺炎喘嗽肺脾湿热证的方药——小儿健脾清肺方（北京中医药大学孙思邈医院院内制剂主要组成）。因此本研究通过临床研究，前瞻性的招募肺炎喘嗽病肺脾湿热证患儿，比较小儿健脾方+西医常规治疗、西医常规治疗组的肺炎转归，肺系外感病复感情况，探索小儿健脾清肺方治疗肺炎喘嗽病肺脾湿热证患儿的有效性和安全性

Objectives of Study：

Pediatric extrapulmonary infections (such as upper respiratory tract infection bronchitis pneumonia etc.) are common and frequent clinical diseases which seriously threaten children's lives and health and respiratory tract infections affect children's health and life expectancy in adulthood increasing the medical burden on society. Professor Gu Xiaohong has been engaged in the prevention and treatment of children's external sensible diseases for a long time and has condensed the syndrome of "gastrointestinal fever" and the common clinical manifestations of gastrointestinal fever include abnormal appetite dry stool bad breath sweating red face eyes restlessness at night red tongue yellow tongue coating pulse count etc. The syndrome of gastrointestinal heat accumulation can also be combined with phlegm and dampness qi deficiency and other syndromes. Based on years of clinical research Professor Gu Xiaohong proposed that children with gastrointestinal heat and dampness are prone to aggravate internal dampness when they suffer from pneumonia and wheezing. After clinical experience and preliminary theoretical research Professor Gu Xiaohong's team developed a prescription for the treatment of pediatric pneumonia asthma lung and spleen dampness and heat syndrome - Pediatric Spleen Qinglung Formula (the main component of the in-hospital preparation of Sun Simiao Hospital of Beijing University of Chinese Medicine). Therefore through clinical research this study prospectively recruited children with pneumonia and asthma disease with lung and spleen dampness and heat syndrome and compared the prognosis of pneumonia and the recurrence of pulmonary infection in the pediatric spleen and asthma treatment groups + conventional treatment of Western medicine and explored the effectiveness and safety of pediatric spleen and clear lung formula in the treatment of children with pneumonia and asthma and lung dampness and heat syndrome

药物成份或治疗方案详述：

试验组辨证属于肺脾湿热证的肺炎患儿，除单纯西医治疗外，包括抗生素头孢、青霉素类、大环类脂类、四环素类等抗生素，化痰剂如氨溴索等，及雾化吸入剂如乙酰半胱氨酸、布地奈德、特步他林等，及退热剂等药物，同步予以小儿健脾清肺方，主要包括广藿香、莱菔子、陈皮、茯苓、桔梗、金银花、连翘等，熬制成汤剂，一天2次，治疗5-7天。 对照组辨证属于肺脾湿热证的肺炎患儿，除单纯西医治疗外，包括抗生素头孢、青霉素类、大环类脂类、四环素类等抗生素，化痰剂如氨溴索等，及雾化吸入剂如乙酰半胱氨酸、布地奈德、特步他林等，及退热剂等药物，同步予以小儿健脾清肺方，主要包括广藿香、莱菔子、陈皮、茯苓、桔梗、金银花、连翘等，熬制成汤剂，一天2次，治疗5-7天

Description for medicine or protocol of treatment in detail：

In addition to simple Western medical treatment the experimental group of children with pneumonia who belonged to the lung-spleen damp-heat syndrome including antibiotics such as cephalosporin penicillin macrocyclic lipids tetracyclines phlegm-reducing agents such as ambroxol and nebulized inhalers such as acetylcysteine budesonide tetetalin etc. and antipyretics and other drugs were simultaneously given to children to strengthen the spleen and clear the lungs mainly including patchouli sulforaphane tangerine peel poria cocos bellflower honeysuckle forsythia etc. boiled into a decoction twice a day for 5-7 days. In addition to simple Western medical treatment the control group of children with pneumonia who belonged to the lung-spleen damp-heat syndrome including antibiotics such as cephalosporins penicillins macrocyclic lipids tetracyclines phlegm-reducing agents such as ambroxol and nebulized inhalers such as acetylcysteine budesonide testepaline etc. and antipyretics and other drugs were simultaneously given to children to strengthen the spleen and clear the lungs mainly including patchouli sulforaphane seed tangerine peel poria cocos bellflower honeysuckle forsythia etc. boiled into a decoction twice a day treatment for 5-7 days

纳入标准：

1. 1 周岁≤年龄≤14 周岁儿童； 2. 符合下面西医诊断及中医辨证标准 ①西医诊断：根据 2019 年国家卫生健康委办公厅和国家中医药管理局印发《儿童社区获得性肺炎诊疗规范（2019 年版》诊断。以发热、咳嗽、喘息症状为主要临床表现。体征出现呼吸增快和湿性啰音、呼吸频率增快，肺部肺纹理 加粗或胸部片状阴影。 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“肺炎喘嗽”，以气喘、咳嗽、咳 痰、痰鸣、发热、肺部可闻及中、细湿啰音为主要表现的患者。 中医辨证：肺脾湿热证 主症：发热、咳嗽、咳声重浊、喘息、咽红、便秘或便溏不爽。 次症：鼻塞、流涕、咳痰、口臭、纳差食少、腹胀或腹痛、小便黄。 舌脉及其他：舌质红，舌苔黄腻/白腻，脉濡数或滑，指纹紫滞，颌下结节； 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. Meet the following criteria for Western medicine diagnosis and TCM syndrome differentiation (1) Western medicine diagnosis: According to the "Standards for the Diagnosis and Treatment of Community-Acquired Pneumonia in Children (2019 Edition)" issued by the General Office of the National Health Commission and the State Administration of Traditional Chinese Medicine in 2019. Fever cough and wheezing were the main clinical manifestations. Signs include tachypnea and crackles increased respiratory rate and pulmonary markings in the lungs Bold or flaky shadow on the chest. (2) Traditional Chinese medicine diagnosis: according to the "Guidelines for Common Diagnosis and Treatment of Pediatric Diseases of Traditional Chinese Medicine" and "Clinical Diagnosis and Treatment of Traditional Chinese Medicine No. 2 Some · syndromes" as the standard and the diagnosis of TCM diseases refers to "pneumonia and wheezing" with wheezing coughing and coughing Patients with sputum sputum sound fever and moderate and fine crackles in the lungs are the main manifestations. TCM syndrome differentiation: lung and spleen dampness and heat syndrome Main symptoms: fever cough dull cough wheezing red throat constipation or loose stools. Secondary symptoms: nasal congestion runny nose phlegm cough bad breath poor appetite abdominal distension or abdominal pain yellow urine. Tongue and veins and others: red tongue yellow/white tongue coating pulses or slippery fingerprints purple submandibular nodules; 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 周的重症肺炎患儿； 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) Children with severe pneumonia whose condition does not improve after active treatment and whose illness lasts for 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：

试验组

样本量：

132

Group：

Experimental group

Sample size：

干预措施：

肺脾湿热证的肺炎患儿，除单纯西医治疗外，同步予以小儿健脾清肺方，主要包括广藿香、莱菔子、陈皮、茯苓、桔梗、金银花、连翘等，熬制成汤剂，一天2次，治疗5-7天

干预措施代码：

Intervention：

Children with pneumonia with feipishire syndrome, in addition to simple Western medicine treatment, are simultaneously given a pediatric spleen and lung clearing formula, mainly including patchouli, sulforaphane, tangerine peel, poria cocos, bellflower, honeysuckle, forsythia, etc., boiled into a decoction, 2 times a day, treatment for 5-7 days

Intervention code：

组别：

对照组

样本量：

132

Group：

Control group

Sample size：

干预措施：

肺炎中肺脾湿热证的肺炎患者，予以西医的抗炎、抗病毒及补液等对症支持治疗 5-7 天

干预措施代码：

Intervention：

Patients with pneumonia with feipishire syndrome in pneumonia are given symptomatic supportive treatment such as anti-inflammatory, antiviral, and rehydration by Western medicine for 5-7 days

Intervention code：

样本总量 Total sample size ： 264

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：

Shaanxi

City：

tongchuan

单位(医院)：

北京中医药大学孙思邈医院

单位级别：

三级甲等

Institution/hospital：

Sun Simiao Hospital Beijing University of Chinese Medicine

Level of the institution：

Class 3A

测量指标：

Outcomes：

指标中文名：

不良事件记录

指标类型：

附加指标

Outcome：

Adverse event records

Type：

Additional indicator

测量时间点：

住院期间

测量方法：

2位专业医务人员评估

Measure time point of outcome：

During hospitalization

Measure method：

Assessed by 2 medical professionals

指标中文名：

患者用药前后试验室检查结果的血常规

指标类型：

主要指标

Outcome：

Routine blood count of laboratory test results before and after medication

Type：

Primary indicator

测量时间点：

住院过程中

测量方法：

检验科化检

Measure time point of outcome：

During hospitalization

Measure method：

Laboratory department conducts chemical tests

指标中文名：

患者的症状情况改善情况如发热时间，咳嗽消失率、咳嗽持续时间等

指标类型：

主要指标

Outcome：

The patient's symptoms are improved, such as the time of fever, the rate of disappearance of cough, and the duration of cough

Type：

Primary indicator

测量时间点：

住院过程中

测量方法：

两位专业医生评估

Measure time point of outcome：

During hospitalization

Measure method：

Evaluated by two professional doctors

指标中文名：

患儿消化道症状，如纳差、腹胀、腹泻

指标类型：

次要指标

Outcome：

Gastrointestinal symptoms, such as anorexia, bloating, diarrhea, etc

Type：

Secondary indicator

测量时间点：

住院过程中

测量方法：

两名专业医生进行评估

Measure time point of outcome：

During hospitalization

Measure method：

Two professional doctors will conduct the evaluation

指标中文名：

呼吸道复感复感情况

指标类型：

次要指标

Outcome：

Respiratory relapsed

Type：

Secondary indicator

测量时间点：

出院后半年内

测量方法：

电话随访

Measure time point of outcome：

Within half a year after discharge

Measure method：

Telephone follow-up

指标中文名：

两组患者体征如呼吸频率、湿罗音持续时间、咽部红肿、扁桃体红肿情况等。

指标类型：

主要指标

Outcome：

Signs such as respiratory rate, crackle duration, pharyngeal redness and swelling, and tonsil redness and swelling were found in both groups.

Type：

Primary indicator

测量时间点：

住院过程中

测量方法：

两位专业医生进行查体

Measure time point of outcome：

During hospitalization

Measure method：

Two medical professionals will perform a physical examination

指标中文名：

出院后患者的症状如咳嗽、咳痰、乏力、食欲情况

指标类型：

次要指标

Outcome：

Symptoms such as cough sputum production fatigue and appetite after discharge from the hospital

Type：

Secondary indicator

测量时间点：

出院后一个月内

测量方法：

电话随访

Measure time point of outcome：

Within one month after discharge

Measure method：

Telephone follow-up

指标中文名：

测量儿童的身高、体重，计算BMI

指标类型：

次要指标

Outcome：

The height and weight of the child are measured and the BMI is calculated

Type：

Secondary indicator

测量时间点：

住院期间

测量方法：

专业护士测量

Measure time point of outcome：

During hospitalization

Measure method：

Measured by a professional nurse

指标中文名：

患者用药前后试验室检查结果的生化结果

指标类型：

主要指标

Outcome：

Biochemical results of laboratory examination results before and after medication in patients

Type：

Primary indicator

测量时间点：

住院过程中

测量方法：

检验科

Measure time point of outcome：

During hospitalization

Measure method：

laboratory tests

指标中文名：

患者的住院时间

指标类型：

主要指标

Outcome：

Length of hospital stay for the patient

Type：

Primary indicator

测量时间点：

住院过程中

测量方法：

住院病例中查找

Measure time point of outcome：

During hospitalization

Measure method：

Hospitalized cases

指标中文名：

受试儿童的饮食行为

指标类型：

次要指标

Outcome：

Eating behaviour of the children in question

Type：

Secondary indicator

测量时间点：

住院期间

测量方法：

问卷调查

Measure time point of outcome：

During hospitalization

Measure method：

Questionnaires

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

检验科遗留废弃血样本

组织：

Sample Name：

Discarded blood samples left behind by 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：

检验科遗留尿样本

组织：

Sample Name：

Urine sample left by 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：

检验科遗留便样本

组织：

Sample Name：

Stool samples left over 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）：

由专业人员人员使用SPSS生成随机数字表，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，同步予以小儿健脾清肺方治疗。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。

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

A random number table was generated by professionals using SPSS 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. Under the treatment of conventional Western medicine the patients in the experimental group were simultaneously treated with Pediatric Spleen and Lung Clearing Formula. 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.

盲法：

Blinding：

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）：

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)：

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：

原始文件由研究者采集患者的基本信息，采集患者的一般资料（包括人口学资料，病史资料），采集患者症状变化规律），对患者症状和 体征进行 采集，患者住院期间的检查结果、住院期间用药、出院转归、出院情况均进行详细CRF记录。同步对患者进行 随访。采集的信息由专人培训后录入，采用excel对数据进行 整理，专业统计软件SPSS、R语言进行分析

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

The original document is collected by the investigator to collect the basic information of the patient collect the general data of the patient (including demographic data medical history data) collect the patient's symptoms and signs) collect the patient's symptoms and signs and make detailed CRF records of the patient's examination results during hospitalization medication during hospitalization discharge prognosis and discharge. Patients were followed up at the same time. The collected information is entered by special personnel after training the data are sorted out by excel and analyzed by professional statistical software SPSS and R languages

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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