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Efficacy of Chinese Herbal Tea in the Prevention of Novel Coronavirus Pneumonia (COVID-19): a Randomized Controlled Trial
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注册号:

Registration number:

ChiCTR2000031944 

最近更新日期:

Date of Last Refreshed on:

2020-04-15 

注册时间:

Date of Registration:

2020-04-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中药茶饮预防新型冠状病毒肺炎(COVID-19)的作用:随机对照试验 

Public title:

Efficacy of Chinese Herbal Tea in the Prevention of Novel Coronavirus Pneumonia (COVID-19): a Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

武汉市复工人群服用中药茶饮预防新型冠状病毒肺炎(COVID-19)的研究:随机对照试验 

Scientific title:

Efficacy of Chinese Herbal Tea in the Prevention of Novel Coronavirus Pneumonia (COVID-19) for Returning Workers in Wuhan: a Randomized Controlled Trial 

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:

ChiMCTR2000003212 

申请注册联系人:

刘斌 

研究负责人:

吕诚 

Applicant:

Liu Bin 

Study leader:

Lu Cheng 

申请注册联系人电话:

Applicant telephone:

+86 010-64093104 

研究负责人电话:

Study leader's telephone:

+86 010-64093264 

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:

lynch1123@126.com 

研究负责人电子邮件:

Study leader's E-mail:

lv_cheng0816@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:

北京市东城区东直门内南小街16号 

研究负责人通讯地址:

北京市东城区东直门内南小街16号 

Applicant address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, China 

Study leader's address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, 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:

中国中医科学院 

Applicant's institution:

China Academy of Chinese Medical Sciences 

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:

CACMS-IRB2020-004 

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:

中国中医科学院医学伦理委员会 

Name of the ethic committee:

Ethics Review Committee of China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-14 

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:

中国中医科学院 

Primary sponsor:

China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市东城区东直门内南小街16号 

Primary sponsor's address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院

具体地址:

东城区东直门内南小街16号

Institution
hospital:

China Academy of Chinese Medical Sciences

Address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District

经费或物资来源:

国家重点研发计划资助(No.2020YFC0841500) 

Source(s) of funding:

National Key R&D Program of China (No.2020YFC0841500) 

研究疾病:

新型冠状病毒肺炎 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评价中药茶饮对武汉市复工人群预防新型冠状病毒肺炎(COVID-19)的效果。 

Objectives of Study:

To evaluate the effect of Chinese herbal tea on the prevention of COVID-19 in returning workers in Wuhan. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)男女性均可,18岁≦年龄≦75岁; (2)地域限定为湖北省武汉市; (3)自愿参加本项研究,并签署知情同意书。 

Inclusion criteria

(1) Both male and female, 18 years old <= aged <= 75 years old; (2) The territory is limited to wuhan, hubei province; (3) Voluntarily participate in the study and sign the informed consent. 

排除标准:

(1)合并心、脑、肝、肾和造血系统等严重原发性疾病者; (2)合并肺部恶变者; (3)合并精神、智力或语言障碍者; (4)孕妇、哺乳期妇女及近6个月有妊娠要求者; (5)不能熟练使用手机、电脑等填写问卷资料者; (6)不愿意接受中药茶饮者,或既往有中药过敏史者; (7)服用其它中药茶饮者; (8)曾确诊COVID-19并痊愈者。 

Exclusion criteria:

(1) People with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system; (2) People with pulmonary malignancy; (3) Combined with mental, intellectual or language disorders; (4) Pregnant women, lactating women and those who have pregnancy requirement in the last 6 months; (5) People who cannot skillfully use mobile phones or computers to fill in the questionnaire; (6) People who are not willing to accept Chinese herbal tea, or those who have a history of allergy to Chinese herbal medicine; (7) People who are using other Chinese herbal tea; (8) People who had been diagnosed with covid-19 and recovered. 

研究实施时间:

Study execute time:

From2020-04-16To 2020-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

1000

Group:

experimental group

Sample size:

干预措施:

中药茶饮

干预措施代码:

Intervention:

Chinese herbal tea

Intervention code:

组别:

对照组

样本量:

1000

Group:

control group

Sample size:

干预措施:

正常饮用水

干预措施代码:

Intervention:

drinking water

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

中国中医科学院 

单位级别:

科研院所 

Institution
hospital:

China Academy of Chinese Medical Sciences?  

Level of the institution:

scientific research institute 

测量指标:

Outcomes:

指标中文名:

核酸阳性率

指标类型:

主要指标 

Outcome:

the rate of 2019-nCoV RNA positive

Type:

Primary 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:

次要指标 

Outcome:

body temperature

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

症状

指标类型:

次要指标 

Outcome:

symptom

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:

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:

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:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

由中国中医药循证医学中心统计人员使用SAS 9.4软件包产生随机序列。

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

SAS 9.4 software was used to generate random sequences by statisticians from China Center for Evidence-Based Traditional Chinese Medicine.

盲法:

未说明

Blinding:

Not stated

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):

研究完成后,我们将发布研究报告。

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

Research report will be released after trial completion.

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:

中国中医科学院

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

China Academy of Chinese Medical Sciences

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-04-15
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