中医药治疗儿童腺样体肥大前瞻 、观察、多中心的真实世界研究

注册号:

Registration number:

ITMCTR2023000018

最近更新日期:

Date of Last Refreshed on:

2023-06-15

注册时间:

Date of Registration:

2023-06-15

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

中医药治疗儿童腺样体肥大前瞻 、观察、多中心的真实世界研究

Public title:

Prospective, observational, Multicenter real-world study of traditional Chinese medicine in the treatment of adenoid hypertrophy in children

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中医药治疗儿童腺样体肥大前瞻 、观察、多中心的真实世界研究

Scientific title:

Prospective, observational, multicenter real-world study of traditional Chinese medicine in the treatment of adenoid hypertrophy in children

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:

ZD202219

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:

陶嘉磊

研究负责人:

袁斌

Applicant:

taojiialei

Study leader:

yuanbin

申请注册联系人电话:

Applicant telephone:

15850503757

研究负责人电话:

Study leader's telephone:

13851463308

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

025-86617141-91108

申请注册联系人电子邮件:

Applicant E-mail:

502898850@qq.com

研究负责人电子邮件:

Study leader's E-mail:

yfy0045@njucm.edu.cn

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:

江苏省南京市汉中路155号江苏省中医院儿科

研究负责人通讯地址:

江苏省南京市汉中路155号江苏省中医院儿科

Applicant address:

155 Hanzhong Road,Nanjing,Jiangsu

Study leader's address:

155 Hanzhong Road,Nanjing,Jiangsu

申请注册联系人邮政编码:

Applicant postcode:

210029

研究负责人邮政编码:

Study leader's postcode:

210029

申请人所在单位:

江苏省中医院

Applicant's institution:

Jiangsu Province Hospital 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:

2023NL-032-02

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:

南京中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of Affiliated Hospital of Nanjing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2023/3/30 0:00:00

伦理委员会联系人:

王卯

Contact Name of the ethic committee:

Wang Mao

伦理委员会联系地址:

南京市秦淮区汉中路155号江苏省中医院5号楼404室

Contact Address of the ethic committee:

155 Hanzhong Road, Nanjing, Jiangsu,China

伦理委员会联系人电话:

Contact phone of the ethic committee:

02586617141-50404

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llwyhbgs@qq.com

研究实施负责(组长)单位:

南京中医药大学附属医院(江苏省中医院)

Primary sponsor:

Affiliated Hospital of Nanjing University of Chinese Medicine(Jiangsu Hospital of Traditional Chinese Medicine)

研究实施负责(组长)单位地址:

江苏省南京市秦淮区汉中路155号南京中医药大学附属医院(江苏省中医院)

Primary sponsor's address:

155 Hanzhong Road,Qinhuai District,Nanjing,Jiangsu

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu Province

City:

Nan Jing

单位(医院):

江苏省中医院

具体地址:

江苏省南京市汉中路155号j江苏省中医院儿科

Institution
hospital:

Jiangsu Hospital of Traditional Chinese Medicine

Address:

155 Hanzhong Road,Nanjing,Jiangsu

经费或物资来源:

江苏省中医药科技发展计划项目(编号:ZD202219)

Source(s) of funding:

Jiangsu Traditional Chinese Medicine Science and Technology Development Plan Project(No.:ZD202219)

研究疾病:

儿童腺样体肥大

研究疾病代码:

Target disease:

Pediatric adenoid hypertrophy

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

其它

Others

研究目的:

1.分析腺样体肥大诊疗方案和临床路径的普适性,通过优化形成诊疗规范。 2.评价各证型中药方(包括益气活血消腺方),贴敷等治疗手段干预腺样体肥大的有效性与安全性。

Objectives of Study:

1. Analyze the universality of adenoid hypertrophy diagnosis and treatment plans and clinical pathways, and form diagnosis and treatment norms through optimization 2.Evaluate the effectiveness and safety of various types of traditional Chinese medicine prescriptions (including the prescription of invigorating qi and blood to shrink adenoids), patches and other therapeutic methods for intervention in adenoid hypertrophy.

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.年龄6个月~14周岁,男女不限。 2.符合西医腺样体肥大诊断标准。 3. 患儿家属知情同意,志愿受试。获得知情同意书过程应符合GCP规定。

Inclusion criteria

1.Age ranges from 6 months to 14 years old, regardless of gender 2.Meet the diagnostic criteria of Western medicine for adenoid hypertrophy; 3.The children's family gave informed consent and volunteered for the test. The process of obtaining informed consent shall comply with GCP regulations

排除标准:

1.不符合纳入标准者; 2.2周内接受过其他腺样体肥大药物治疗者; 3.对试验药物过敏者; 4.合并心、肝、肾、消化及造血系统等严重原发病或感染性疾病急性发作者; 5.有严重鼻中隔偏曲、鼻息肉、喉部及气管疾病等引起呼吸困难者; 6.伴有严重并发症如肺心病、肺动脉高压等者。

Exclusion criteria:

1.Those who do not meet the inclusion criteria; 2.Those who have received other adenoid hypertrophy drugs treatment within 2 weeks 3.Those who are allergic to the test drug 4.People with serious primary diseases or acute attacks of infectious diseases such as heart, liver, kidney, digestive and hematopoietic systems 5.Those with severe nasal septal deviation, nasal polyps, laryngeal and tracheal diseases that cause breathing difficulties 6.Accompanied by serious complications such as pulmonary heart disease, pulmonary hypertension, etc

研究实施时间:

Study execute time:

From 2024-01-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2024-01-01

To      2025-12-31

干预措施:

Interventions:

组别:

非暴露组

样本量:

2000

Group:

non-exposure group

Sample size:

干预措施:

西药对症治疗

干预措施代码:

Intervention:

Symptomatic treatment with western medicine

Intervention code:

组别:

暴露组

样本量:

6000

Group:

exposure group

Sample size:

干预措施:

中药辨证施治(包括益气活血消腺方)和贴敷疗法

干预措施代码:

Intervention:

traditional Chinese medicine treatment based on syndrome differentiation (including the prescription of invigorating qi and blood to shrink adenoids),and patches treatment

Intervention code:

样本总量 Total sample size : 8000

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京市中西医结合医院

单位级别:

三级甲等

Institution/hospital:

Affiliated Hospital of Nanjing University of Chinese Medicine(Nanjing Integrated Traditional and Western Medicine Hospital)

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

江苏省

市(区县):

盐城市

Country:

China

Province:

Jiangsu

City:

Yancheng

单位(医院):

盐城市中医院

单位级别:

三级甲等

Institution/hospital:

Affiliated Hospital of Nanjing University of Chinese Medicine(Yancheng 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):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京中医药大学附属医院(江苏省中医院)

单位级别:

三级甲等

Institution/hospital:

Affiliated Hospital of Nanjing University of Chinese Medicine(Jiangsu Hospital of Traditional Chinese Medicine)

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

咳嗽缓解率

指标类型:

次要指标

Outcome:

cough relief 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:

腺样体厚度/鼻咽部宽度比值

指标类型:

主要指标

Outcome:

Ratio of Adenoid thickness to nasopharyngeal width

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

纳少缓解率

指标类型:

次要指标

Outcome:

poor appetite relief 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:

气短懒言缓解率

指标类型:

次要指标

Outcome:

Weak and lazy speech relief 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:

睡眠打鼾缓解率与缓解时间

指标类型:

主要指标

Outcome:

Sleep snoring relief rate and relief time

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头晕头痛缓解率

指标类型:

次要指标

Outcome:

Dizziness and headache relief 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:

流涕缓解率

指标类型:

次要指标

Outcome:

runny nose relief 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:

便溏或便秘缓解率

指标类型:

次要指标

Outcome:

Loose stools or constipation relief 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:

咽部不利缓解率

指标类型:

次要指标

Outcome:

Pharyngeal discomfort relief 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:

抗生素合并使用率

指标类型:

次要指标

Outcome:

Combined use rate of antibiotics

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

鼻塞缓解率与缓解时间

指标类型:

主要指标

Outcome:

nasal obstruction relief rate and relief time

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汗多缓解率

指标类型:

次要指标

Outcome:

Profuse sweating relief 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:

张口呼吸缓解率与缓解时间

指标类型:

主要指标

Outcome:

Open mouth breathing relief rate and relief time

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

面色少华缓解率

指标类型:

次要指标

Outcome:

A dull complexion relief rate

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:

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 1
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):

N/A

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

N/A

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):

Not stated

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

Not stated

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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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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