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Clinical study for community based prevention and control strategy of novel coronavirus pneumonia (COVID-19) in the isolate suspected and confirmed population
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注册号:

Registration number:

ChiCTR2000029602 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于社区防控的“新型冠状病毒肺炎(COVID-19)”居家/定点隔离观察人群的临床研究 

Public title:

Clinical study for community based prevention and control strategy of novel coronavirus pneumonia (COVID-19) in the isolate suspected and confirmed population 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于社区防控的“新型冠状病毒肺炎(COVID-19)”居家/定点隔离观察人群的临床研究 

Scientific title:

Clinical study for community based prevention and control strategy of novel coronavirus pneumonia (COVID-19) in the isolate suspected and confirmed population 

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:

ChiMCTR2000002974 

申请注册联系人:

肖明中 

研究负责人:

仝小林 

Applicant:

Mingzhong Xiao 

Study leader:

Xiaolin Tong 

申请注册联系人电话:

Applicant telephone:

+86 18908640865 

研究负责人电话:

Study leader's telephone:

+86 13910662116 

申请注册联系人传真 :

Applicant Fax:

+86 027- 88844689 

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:

309452513@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

Xiaolintong66@sina.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:

湖北省武汉市洪山区珞瑜路856号 

研究负责人通讯地址:

湖北省武汉市洪山区珞瑜路856号 

Applicant address:

856 Luoyu Road, Hongshan District, Wuhan, Hubei, China 

Study leader's address:

856 Luoyu Road, Hongshan District, Wuhan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

430071 

研究负责人邮政编码:

Study leader's postcode:

430071 

申请人所在单位:

湖北省中医院 

Applicant's institution:

Hubei Provincial Hospital of TCM 

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:

HBZY2020-C01-01 

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:

湖北省中医院伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Hubei Provincial Hospital of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-01 

伦理委员会联系人:

张馨 

Contact Name of the ethic committee:

Xin Zhang 

伦理委员会联系地址:

湖北省武汉市洪山区珞瑜路856号 

Contact Address of the ethic committee:

856 Luoyu Road, Hongshan District, Wuhan, Hubei, 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:

湖北省中医院 

Primary sponsor:

Hubei Provincial Hospital of TCM 

研究实施负责(组长)单位地址:

湖北省武汉市洪山区珞瑜路856号 

Primary sponsor's address:

856 Luoyu Road, Hongshan District, Wuhan, Hubei, 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):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

湖北省中医院

具体地址:

湖北省武汉市洪山区珞瑜路856号

Institution
hospital:

Hubei Provincial Hospital of TCM

Address:

856 Luoyu Road, Hongshan District

经费或物资来源:

国家中医药管理局项目 

Source(s) of funding:

Project of State Administration of Traditional Chinese Medicine of China 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

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:

探索性研究/预试验 

Study phase:

研究目的:

以居家/定点隔离观察人群为干预对象,引入“武昌民生健康云”平台,利用家庭医生团队结合中医药干预方法,探讨中医药在重大传染性疾病预防中的有效性,并从其中探索出一套突发重大公共卫生事件中医药参与的社区防控新模式。 

Objectives of Study:

Taking the home/designated isolation and observed population as the intervention objects, introducing the "Wuchang livelihood Health Cloud" platform, and taking advantage of team of family doctors in combination with traditional Chinese medicine intervention methods, to explore the effectiveness of traditional Chinese medicine in the prevention of severe infectious diseases, and to find a new community prevention and control model with the participation of Chinese medicine in major public health emergencies. 

药物成份或治疗方案详述:

将武昌区社区卫生服务中心监管的居家/定点隔离观察人群,随机分为对照组和治疗组,对照组予以健康宣教、家庭医生团队跟踪病情管理;治疗组予以健康宣教、家庭医生团队跟踪病情管理、联合中药治疗,中药治疗选用藿香正气滴丸,用法:1次1袋,2次/日。 疗程:所有组观察时间均为14天。 

Description for medicine or protocol of treatment in detail:

The home/designated isolation population under the supervision of the Community Health Service Center of Wuchang District was divided into observation group and randomized control group according to their wishes. The control group receive health education and follow-up condition management by team of family doctors; The treatment group receive health education, follow-up condition management by team of family doctors, combined with traditional Chinese medicine treatment of Huoxiang zhengqi dripping pills. Usage: 1 bag once, 2 times a day. Course of treatment: The observation time of all groups was 14 days. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①符合上述密切接触者的诊断标准; ②年龄18-65周岁,性别不限; ③签署泛化告知式的知情同意书(根据意愿纳入临床研究)。 

Inclusion criteria

1. Conforming to the diagnostic criteria for the above close contacts; 2. Aged between 18 and 65 years old; 3. Signing the generalized informed consent form. (The intervention objects is incorporated in the clinical study as desired). 

排除标准:

①重型或危重型患者; ②有明确细菌感染证据; ③合并心、肾、肺、内分泌、血液、代谢及胃肠道等严重原发病,经研究者判断,可能影响患者参加试验或影响研究的转归; ④有精神病家族史或本人曾有精神疾病者; ⑤过敏体质或多种药过敏者; ⑥孕妇或哺乳期妇女。 

Exclusion criteria:

1. Severe or critically severe patients; 2. Clear evidence of bacterial infection; 3. Patients with severe primary diseases such as heart, kidney, lung, endocrine, blood, metabolism, and gastrointestinal tract, etc., may affect participation in the trial or may affect the outcome of the study by the judgment of the researcher; 4. Patients who have a family history of mental illness or have had a mental illness; 5. Patients who are allergic constitution or allergy to multiple drug; 6. pregnant or lactating women. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-08-01 

征募观察对象时间:

Recruiting time:

From2020-02-01To 2020-03-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

300

Group:

Experimental group

Sample size:

干预措施:

健康宣教、家庭医生团队跟踪病情管理、中药治疗

干预措施代码:

Intervention:

health education, follow-up condition management by team of family doctors, Chinese medicine treatment

Intervention code:

组别:

对照组

样本量:

300

Group:

Control group

Sample size:

干预措施:

健康宣教、家庭医生团队跟踪病情管理

干预措施代码:

Intervention:

health education, follow-up condition management by team of family doctors

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北省中医院 

单位级别:

三级甲等 

Institution
hospital:

Hubei Provincial Hospital of TCM  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

居家/定点隔离观察者进展为居家/定点隔离治疗者的发病率

指标类型:

主要指标 

Outcome:

Incidence of onset at home / designated isolation population who progressed to designated isolation treatment or were diagnosed with novel coronavirus-infected pneumonia

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

居家/定点隔离观察者进展为居家/定点隔离治疗者的发病天数

指标类型:

主要指标 

Outcome:

days of onset at home / designated isolation population who progressed to designated isolation treatment or were diagnosed with novel coronavirus-infected pneumonia

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:

症状量表

指标类型:

次要指标 

Outcome:

Symptom Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医体质

指标类型:

附加指标 

Outcome:

TCM Constitution

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

舌象

指标类型:

附加指标 

Outcome:

Tongue image

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:

咽拭子

组织:

Sample Name:

throat swabs

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 65 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):

采用简单随机化。以个体为单位将研究对象按照1:1分配到实验组和对照组。通过SAS软件的相应随机化程序产生两组随机号。SAS随机化程序相关参数及结果由试验设计单位保存。

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

Subjects are assigned to treatment group and control group on a 1:1 basis by simple randomization. Two groups of random numbers will be generated through corresponding randomization program of SAS software.The relevant parameters and results of SAS randomization program were saved by experimental design unit.

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

公开发表学术论文

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

Publish academic papers

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:

病例采集表采用“武昌民生健康云”微信服务平台收集数据,电子采集和管理系统

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

Use "Wuchang livelihood Health Cloud" platform to Collect and manage subject data,and Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-06
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