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新型冠状病毒肺炎(COVID-19)疫情下社区人群中医药技术防控方案
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注册号:

Registration number:

ChiCTR2000029479 

最近更新日期:

Date of Last Refreshed on:

2020-05-31 

注册时间:

Date of Registration:

2020-02-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)疫情下社区人群中医药技术防控方案 

Public title:

Research for Traditional Chinese Medicine Technology Prevention and Control of Novel Coronavirus Pneumonia (COVID-19) in the Community Population 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

使用中药降低新冠肺炎流行期间感冒的风险:在社区居民中进行的大型群组随机临床试验的方案 

Scientific title:

Use of Herbal Medicines to Reduce Risk of the Common Cold During COVID-19 Pandemic: a Large Randomized Clinical Trial Among Community-Dwelling Residents 

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:

ChiMCTR2000002961 

申请注册联系人:

唐诗韵 

研究负责人:

唐健元 

Applicant:

Tang Shiyun 

Study leader:

Tang Jianyuan 

申请注册联系人电话:

Applicant telephone:

+86 13658080076 

研究负责人电话:

Study leader's telephone:

+86 13910768464 

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:

346873785@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

tangjianyuan163@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:

四川省成都市金牛区十二桥路39号 

研究负责人通讯地址:

四川省成都市金牛区十二桥路39号 

Applicant address:

39 Shi-Er-Qiao Road, Jinniu District, Chengdu, Sichuan, China 

Study leader's address:

39 Shi-Er-Qiao Road, Jinniu District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610072 

研究负责人邮政编码:

Study leader's postcode:

610072 

申请人所在单位:

成都中医药大学附属医院 

Applicant's institution:

Hospital of Chengdu 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:

2020QKL-001 

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:

四川中医药区域伦理审查委员会 

Name of the ethic committee:

Sichuan Regional Ethical Review Committee of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-27 

伦理委员会联系人:

何青 

Contact Name of the ethic committee:

He Qing 

伦理委员会联系地址:

四川省成都市金牛区十二桥路39号 

Contact Address of the ethic committee:

39 Shi-Er-Qiao Road, Jinniu District, Chengdu, Sichuan, 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:

成都中医药大学附属医院 

Primary sponsor:

Hospital of Chengdu University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

四川省成都市金牛区十二桥路39号 

Primary sponsor's address:

39 Shi-Er-Qiao Road, Jinniu District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学附属医院

具体地址:

金牛区十二桥路39号

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Address:

39 Shi-Er-Qiao Road, Jinniu District

经费或物资来源:

四川省科技厅、太极集团 

Source(s) of funding:

Science & Techology Department of Sichuan Province, Taiji Group 

研究疾病:

普通感冒 

Target disease:

common cold 

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:

评估两种中药(金蒿解热颗粒和藿香正气口服液)减少新冠肺炎流行期间中国社区居民普通感冒的疗效。 

Objectives of Study:

The purpose of this study was to evaluate the effects of two herbal medicines (Jinhao artemisia antipyretic granules and Huoxiangzhengqi oral liquids) in reducing the risk of the common cold in community-dwelling residents in China during the COVID-19 outbreak. 

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.身体无不适症状; 2.16周岁及以上; 3.自愿服用本方案建议用药者。 

Inclusion criteria

1. No physical discomfort; 2. Aged 16 years old and above; 3. Take the medicine recommended by this research voluntarily. 

排除标准:

若有以下情况之一者,不建议服用本方案推荐中药制剂: (1)已有发热、咳嗽、乏力、鼻塞、流涕、咽干,口渴、大便不畅或便溏、痰少或有痰、胸闷、腹胀、便秘等不适症状; (2)合并心脑血管、肺、肾和造血系统严重原发性疾病者; (3)妊娠或哺乳期妇女; (4)对处方中药物过敏史者。 

Exclusion criteria:

If one of the following situations occurs, it is not recommended to take the traditional Chinese medicine preparation recommended by this plan: (1) Has fever, cough, fatigue, stuffy nose, runny nose, dry throat, thirst, poor stool or diarrhea, little sputum or sputum, chest tightness, abdominal distension, constipation and other discomfort symptoms; (2) Patients with severe primary diseases of the cardiovascular, cerebrovascular, lung, kidney and hematopoietic system; (3) pregnant or lactating women; (4) History of allergy to prescription drugs. 

研究实施时间:

Study execute time:

From2020-01-30To 2020-05-01 

征募观察对象时间:

Recruiting time:

From2020-01-30To 2020-05-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

10000

Group:

Experimental group

Sample size:

干预措施:

辩证使用中药金蒿清感颗粒(8g,bid)和藿香正气口服液(10ml,bid)治疗加感染预防控制手册

干预措施代码:

-

Intervention:

Dialectical use Jinhao artemisia antipyretic granules(8g,bid) and Huoxiangzhengqi oral liquids(10ml,bid) plus a reference manual for health Infection Prevention & Controlor

Intervention code:

组别:

对照组

样本量:

10000

Group:

Control group

Sample size:

干预措施:

感染预防控制手册

干预措施代码:

Intervention:

a reference manual for health Infection Prevention & Controlor

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

受试者自我报告的普通感冒发生

指标类型:

主要指标 

Outcome:

the occurrence of a patient-reported common cold

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

从收到药物健康指导手册到感冒症状发生的时间

指标类型:

次要指标 

Outcome:

he time in days from the receipt of herbal drugs/placebos and the occurrence of the common cold symptoms.

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

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):

采用SAS统计软件,给定随机种子数,并用简单随机方法产生随机数,根据已产生的随机数,分配是否给予干预。

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

Using SAS statistical software, given a random seed number, and using a simple random method to generate random numbers, according to the generated random number, whether to give intervention.

盲法:

开放

Blinding:

open-label

是否共享原始数据:

IPD sharing

是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):

文献

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

literature

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:

信息采集表和电子数据库

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

Information Collection Form、EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-02
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