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注册号: Registration number: |
ChiCTR2500110734 |
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最近更新日期: Date of Last Refreshed on: |
2025-10-20 13:00:27 |
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注册时间: Date of Registration: |
2025-10-20 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
儿童复方感冒药应用现状登记研究 |
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Public title: |
Registry Study on the Utilization Status of Compound Cold Medicines in Pediatrics |
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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: |
儿童复方感冒药应用现状登记研究 |
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Scientific title: |
Registry Study on the Utilization Status of Compound Cold Medicines in Pediatrics |
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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: |
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申请注册联系人: |
陈强 |
研究负责人: |
陈强 |
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Applicant: |
Chen Qiang |
Study leader: |
Chen Qiang |
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申请注册联系人电话: Applicant telephone: |
+86 791 86383230 |
研究负责人电话:
Study leader's |
+86 13907099745 |
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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: |
jx-cq@163.com |
研究负责人电子邮件: Study leader's E-mail: |
jx-cq@163.com |
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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: |
江西省南昌市红谷滩区碟子湖大道1666号 |
研究负责人通讯地址: |
江西省南昌市红谷滩区碟子湖大道1666号 |
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Applicant address: |
1666, Diezihu Avenue, Honggutan District, Nanchang , Jiangxi Province, China |
Study leader's address: |
1666, Diezihu Avenue, Honggutan District, Nanchang , Jiangxi Province, China |
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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: |
江西省儿童医院 |
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Applicant's institution: |
Jiangxi Provincial Children's Hospital |
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研究负责人所在单位: |
江西省儿童医院 |
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Affiliation of the Leader: |
Jiangxi Provincial Children's Hospital |
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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: |
PJ2025031-01 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
江西省儿童医院药械临床试验伦理委员会 |
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Name of the ethic committee: |
Ethics Committee for Drug and Medical Device Clinical Trials, Jiangxi Provincial Children's Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-08-12 00:00:00 | ||
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伦理委员会联系人: |
彭丹 |
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Contact Name of the ethic committee: |
Peng Dan |
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伦理委员会联系地址: |
江西省南昌市红谷滩区碟子湖大道1666号 |
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Contact Address of the ethic committee: |
1666, Diezihu Avenue, Honggutan District, Nanchang , Jiangxi Province, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 791 86806191 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
271858703@qq.com |
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研究实施负责(组长)单位: |
江西省儿童医院 |
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Primary sponsor: |
Jiangxi Provincial Children's Hospital |
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研究实施负责(组长)单位地址: |
江西省南昌市红谷滩区碟子湖大道1666号 |
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Primary sponsor's address: |
1666, Diezihu Avenue, Honggutan District, Nanchang , Jiangxi Province, 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: |
自选课题(自筹) |
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Source(s) of funding: |
Self-selected project (self-funded) |
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研究疾病: |
上呼吸道感染及流行性感冒 |
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Target disease: |
Upper respiratory tract infections and influenza |
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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: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
1.主要目的: (1)安全性:评估复方氨酚甲麻口服液在临床治疗中治疗儿童上呼吸道感染及流行性感冒不良反应的发生类型、发生率。 (2)有效性:评估复方氨酚甲麻口服液在临床治疗中治疗儿童上呼吸道感染及流行性感冒的效果,包括主要症状(鼻塞、流涕,咳嗽,发热)消失/缓解时间、疾病痊愈/缓解时间。 2.次要目的: 分析复方氨酚甲麻口服液在临床的应用情况,包括患者特征(年龄、疾病病程、严重程度、合并疾病等)、使用剂量、疗程、联合用药、药物调整及原因等。 3.探索目的: (1)探索复方氨酚甲麻口服液用于儿童上呼吸道感染及流行性感冒安全性的影响因素。 (2)探索复方氨酚甲麻口服液用于儿童上呼吸道感染及流行性感冒疗效的影响因素。 |
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Objectives of Study: |
Primary Objectives: Safety: To evaluate the types and incidence of adverse reactions associated with Compound Paracetamol and Methylephedrine Oral Solution in the clinical treatment of upper respiratory tract infections and influenza in children. Efficacy: To assess the effectiveness of Compound Paracetamol and Methylephedrine Oral Solution in the clinical treatment of upper respiratory tract infections and influenza in children, including the time to disappearance/alleviation of key symptoms (nasal congestion, runny nose, cough, fever) and the time to disease recovery/alleviation. Secondary Objectives: To analyze the clinical application of Compound Paracetamol and Methylephedrine Oral Solution, including patient characteristics (age, disease duration, severity, comorbidities, etc.), dosage, treatment duration, concomitant medications, drug adjustments, and reasons for adjustments. Exploratory Objectives: (1) To explore factors influencing the safety of Compound Paracetamol and Methylephedrine Oral Solution in the treatment of upper respiratory tract infections and influenza in children. (2) To explore factors influencing the efficacy of Compound Paracetamol and Methylephedrine Oral Solution in the treatment of upper respiratory tract infections and influenza in children. |
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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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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.经研究者判断,不适合参与本研究者。 |
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Exclusion criteria: |
1.Based on the researchers' assessment, they determined that the individuals were not suitable to participate in this study. |
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研究实施时间: Study execute time: |
从 From 2025-06-01 00:00:00至 To 2027-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-10-23 00:00:00 至 To 2027-12-31 00:00:00 |
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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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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
不公开/Private |
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盲法: |
无 |
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Blinding: |
None |
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是否共享原始数据: IPD sharing |
否No |
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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): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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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: |
电子病例记录表、电子采集和管理系统、电子化患者报告结局 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Electronic Case Report Form(eCRF) & Electronic Data Capture(EDC) & Electronic Patient-Reported Outcomes(ePRO) |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
无/No |