流感预防中药方剂对冬季流感密切接触人群预防效果的前瞻性队列研究

注册号:

Registration number:

ITMCTR2200005602

最近更新日期:

Date of Last Refreshed on:

2022-02-04

注册时间:

Date of Registration:

2022-02-04

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

流感预防中药方剂对冬季流感密切接触人群预防效果的前瞻性队列研究

Public title:

Prospective Cohort Study on the Preventive Effect of Chinese Medicine Prescription of Close Contact Crowd with Winter Influenza

注册题目简写:

English Acronym:

研究课题的正式科学名称:

流感预防中药方剂对冬季流感密切接触人群预防效果的前瞻性队列研究

Scientific title:

Prospective Cohort Study on the Preventive Effect of Chinese Medicine Prescription of Close Contact Crowd with Winter Influenza

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:

ChiCTR2200056350 ; ChiMCTR2200005602

申请注册联系人:

马林沁

研究负责人:

晏军

Applicant:

Ma Linqin

Study leader:

Yan Jun

申请注册联系人电话:

Applicant telephone:

18515055460

研究负责人电话:

Study leader's telephone:

13011112391

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:

mlqmlq818@163.com

研究负责人电子邮件:

Study leader's E-mail:

dzmyyyj@126.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:

北京市东城区海运仓5号

研究负责人通讯地址:

北京市东城区海运仓5号

Applicant address:

Haiyuncang 5th, Dongcheng District, Beijing

Study leader's address:

Haiyuncang 5th, Dongcheng 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:

北京中医药大学东直门医院

Applicant's institution:

Dongzhimen Hospital of 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:

DZMEC-KY-2020-81

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:

北京中医药大学东直门医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee, Dongzhimen Hospital of Beijing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2020/10/28 0:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

北京中医药大学东直门医院

Primary sponsor:

Dongzhimen Hospital of Beijing University of Chinese Medicine

研究实施负责(组长)单位地址:

北京市东城区海运仓5号

Primary sponsor's address:

Haiyuncang 5th, Dongcheng District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东直门医院

具体地址:

北京市东城区海运仓5号

Institution
hospital:

Dongzhimen Hospital of Beijing University of Chinese Medicine

Address:

Haiyuncang 5th, Dongcheng District, Beijing

经费或物资来源:

首都卫生发展科研专项项目

Source(s) of funding:

Beijing Development Scientific Research Special Project

研究疾病:

流行性感冒

研究疾病代码:

Target disease:

Influenza

Target disease code:

研究类型:

Study type:

预防性研究

Prevention

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

I期临床试验

Phase I clinical trial

研究目的:

明确流感预防方的临床预防效果,为流感预防应用中药方剂提供临床数据和证据支持。

Objectives of Study:

To clarify the clinical preventive effect of influenza preventive prescriptions, and to provide clinical data and evidence support for the application of traditional Chinese medicine prescriptions for influenza prevention.

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18-75岁; 2) 每年的11月至次年3月为病例收集期,此试验期内于急诊科门诊或呼吸科门诊临床诊断为流感的患者,其家属、舍友等居住在一起的密切接触者; 3) 自愿参加试验并签署知情同意书。

Inclusion criteria

1) Age 18-75 years old; 2) The case collection period is from November to March of the following year. During this trial period, patients who were clinically diagnosed with influenza in the emergency department outpatient department or respiratory department outpatient department, their family members, roommates and other close contacts living together; 3) Voluntarily participate in the trial and sign the informed consent.

排除标准:

1) 已经出现流感样症状的患者,或需要/正在进行抗生素、抗病毒药物治疗干预中的患者; 2) 已经注射流感疫苗或服用其他中药、中成药制剂预防流感者; 3) 妊娠或哺乳期女性; 4) 严重心脏、肝、肾功能不全或存在其他严重疾病的患者; 5) 已知中药成分过敏者。

Exclusion criteria:

1) Patients who have developed flu-like symptoms, or patients who require/undergo antibiotics and antiviral drug treatment interventions; 2) Those who have been injected with influenza vaccine or take other Chinese medicines and Chinese patent medicines to prevent influenza; 3) Pregnant or lactating women; 4) Patients with severe heart, liver, renal insufficiency or other serious diseases; 5) Those who are known to be allergic to traditional Chinese medicine ingredients.

研究实施时间:

Study execute time:

From 2022-02-07

To      2024-03-31

征募观察对象时间:

Recruiting time:

From 2022-02-07

To      2024-03-01

干预措施:

Interventions:

组别:

试验组/对照组

样本量:

555

Group:

test group / control group

Sample size:

干预措施:

流感预防方

干预措施代码:

Intervention:

flu prevention prescription

Intervention code:

样本总量 Total sample size : 1110

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东直门医院

单位级别:

三级甲等医院

Institution/hospital:

Dongzhimen Hospital of Beijing University of Chinese Medicine

Level of the institution:

tertiary first-class hospital

测量指标:

Outcomes:

指标中文名:

甲型/乙型流感快速筛查试验

指标类型:

主要指标

Outcome:

Influenza A/B Rapid Screening 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:

不良反应

指标类型:

副作用指标

Outcome:

Adverse reactions

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

T淋巴细胞亚群检测

指标类型:

次要指标

Outcome:

Detection of T lymphocyte subsets

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体温

指标类型:

附加指标

Outcome:

body temperature

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症状积分

指标类型:

附加指标

Outcome:

TCM symptom score

Type:

Additional 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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 75
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):

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

none

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

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

none

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

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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