Today is 2019-12-07

Investigation for Epidemiological profile of traditional Chinese Medicine Syndrome of Influenza in Children
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注册号:

Registration number:

ChiCTR1900027551 

最近更新日期:

Date of Last Refreshed on:

2019-11-17 

注册时间:

Date of Registration:

2019-11-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

儿童流行性感冒中医证候流行病学现况调查  

Public title:

Investigation for Epidemiological profile of traditional Chinese Medicine Syndrome of Influenza in Children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

儿童流行性感冒中医证候流行病学现况调查 

Scientific title:

Investigation for Epidemiological profile of traditional Chinese Medicine Syndrome of Influenza in Children 

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:

ChiMCTR1900025349 

申请注册联系人:

王程婷 

研究负责人:

马融 

Applicant:

Chengting Wang 

Study leader:

Rong Ma 

申请注册联系人电话:

Applicant telephone:

+86 15222039913 

研究负责人电话:

Study leader's telephone:

+86 13803093399 

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:

1545463812@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

mr1974@163.com 

申请单位网址(自愿提供):

Applicant 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:

天津市西青区昌凌路88号 

研究负责人通讯地址:

天津市西青区昌凌路88号 

Applicant address:

88 Changling Road, Xiqing District, Tianjin, China 

Study leader's address:

88 Changling Road, Xiqing District, Tianjin, China 

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:

天津中医药大学 

Applicant's institution:

Tianjin University of Traditional Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

TYLL2019[K]字 025 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

天津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 Teaching Hospital of Tianjin University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

贾景蕴 

Contact Name of the ethic committee:

Jingyun JIA 

伦理委员会联系地址:

天津市西青区昌凌路88号天津中医药大学第一附属医院 

Contact Address of the ethic committee:

The First teaching Hospital of Tianjin University of TCM, 88 Changling Road, Xiqing District, Tianjin, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

天津中医药大学第一附属医院 

Primary sponsor:

First teaching Hospital of Tianjin University of TCM 

研究实施负责(组长)单位地址:

天津市西青区昌凌路88号 

Primary sponsor's address:

88 Changling Road, Xiqing District, Tianjin, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津市

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

天津市西青区昌凌路88号

Institution
hospital:

The First teaching Hospital of Tianjin University of TCM

Address:

88 Changling Road, Xiqing District, Tianjin, China

经费或物资来源:

国家中医药管理局 

Source(s) of funding:

National Administration of Traditional Chinese Medicine 

研究疾病:

流行性感冒 

Target disease:

Inlfluenza 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

通过多中心、大样本的临床流行病学调查,系统研究和探讨我国儿童流感中医证候类型及分布情况,确立其主要症状分布,为今后更好地指导儿童流行性感冒的中医干预提供参考依据。 

Objectives of Study:

Through the clinical epidemiological investigation of multi-center and large samples, the system studies and probes into the type and distribution of traditional Chinese medicine syndrome, and establishes its main symptom distribution, which provides a reference for the better guidance of the traditional Chinese medicine intervention for children undefineds influenza. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

(1)年龄<18岁; (2)根据《流行性感冒诊疗方案(2018年版修订版)》,出现流感临床表现,有流行病学证据,排除其他引起流感样症状的疾病,且做流感病毒检测的患儿; (3)知情同意。过程符合规定,法定代理人或与受试儿童(≧8岁)共同签署知情同意书。 

Inclusion criteria

(1) Aged than 18 years; (2) According to the diagnosis and treatment plan for influenza (version 2018), the clinical manifestation of the influenza and the epidemiological evidence, the exclusion of other diseases causing the symptoms of the influenza, and the detection of the influenza virus; (3) Informed consent. The process is in accordance with the regulations, and the legal representative or the children under test (at the age of 8) jointly sign the informed consent form. 

排除标准:

(1)正在接受系统类固醇治疗或其他免疫调节剂治疗; (2)严重营养不良、佝偻病及合并心、脑、肝、肾及造血系统等严重原发性疾病者。 

Exclusion criteria:

(1) Being treated with a systemic steroid therapy or other immunomodulator; (2) Severe primary diseases such as severe malnutrition, Parkinsonundefineds disease and combined heart, brain, liver, kidney and hematopoietic system. 

研究实施时间:

Study execute time:

From2019-11-01To 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

32000

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东方医院 

单位级别:

三级甲等 

Institution
hospital:

Dongfang Hospital Beijing University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

 

Country:

China 

Province:

Gansu 

City:

 

单位(医院):

甘肃中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Gansu University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

甘肃省 

市(区县):

 

Country:

China 

Province:

Gansu 

City:

 

单位(医院):

甘肃省中医院 

单位级别:

三级甲等 

Institution
hospital:

Gansu Provincial Hospital of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

 

单位(医院):

乌鲁木齐市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Urumqi Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

 

单位(医院):

新疆伊犁州中医医院 

单位级别:

三级甲等 

Institution
hospital:

Xinjiang Yili State Hospital of traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳市儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Children's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

佛山市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Foshan Maternal and Child Health Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

厦门市中医院 

单位级别:

三甲医院 

Institution
hospital:

Xiamen Hospital of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江中医药大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

吉林省 

市(区县):

 

Country:

China 

Province:

Jilin 

City:

 

单位(医院):

长春中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hospital of Changchun University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

大庆市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Traditional Chinese Medicine Hospital of Daqing City  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Henan University of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

郑州市中医院 

单位级别:

三级甲等 

Institution
hospital:

Traditional Chinese Medicine Hospital of Zhengzhou  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

开封市儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Children's hospital of Kaifeng city  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

开封市中医院 

单位级别:

三级甲等 

Institution
hospital:

Kaifeng hospital of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First teaching Hospital of Tianjin University of TCM  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

儿童流感症状量表

指标类型:

主要指标 

Outcome:

Children‘s influenze symptom of TCM constitution scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

Blood test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

C reactive protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

流感病毒病原学检测

指标类型:

主要指标 

Outcome:

Etiological detection of influenza virus

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患儿一般资料

指标类型:

主要指标 

Outcome:

General data

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:

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:

咽拭子

组织:

Sample Name:

throat swab

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A, 分层简单随机抽样

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

N/A, Stratified simple random sampling

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

文章、论文发表

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

articles and paper

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:

由调查问卷进行数据采集,数据软件管理数据

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

Data collection by questionnaire, data management by data software

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-17
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