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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
天津中医药大学 |
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Applicant's institution: |
Tianjin University of Traditional Chinese Medicine |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Ethics committee of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine |
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伦理委员会批准日期: Date of approved by ethic committee: |
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伦理委员会联系人: |
贾景蕴 |
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Contact Name of the ethic committee: |
Jingyun JIA |
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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 |
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Contact Address of the ethic committee: |
The First teaching Hospital of Tianjin University of TCM, 88 Changling Road, Xiqing District, Tianjin, China |
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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 |
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Primary sponsor: |
First teaching Hospital of Tianjin University of TCM |
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研究实施负责(组长)单位地址: |
天津市西青区昌凌路88号 |
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Primary sponsor's address: |
88 Changling Road, Xiqing District, Tianjin, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
国家中医药管理局 |
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Source(s) of funding: |
National Administration of Traditional Chinese Medicine |
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研究疾病: |
流行性感冒 |
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Target disease: |
Inlfluenza |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
流行病学研究 |
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Study type: |
Epidemilogical research |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
连续入组 |
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Study design: |
Sequential |
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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。 |
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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. |
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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。 |
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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. |
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研究实施时间: Study execute time: |
从From2019-11-01至To 2020-12-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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