新型冠状病毒肺炎密切接触者的艾灸防治

注册号:

Registration number:

AMCTR-IPR-20000326 

注册号获得时间:

Date of releasing the registration number:

2020/4/14 14:53:04 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

新型冠状病毒肺炎密切接触者的艾灸防治 

Public title:

Research on close contacts of novel coronavirus pneumonia with moxibustion 

研究课题的正式科学名称:

新型冠状病毒肺炎密切接触者的艾灸防治 

Scientific title:

Research on close contacts of novel coronavirus pneumonia with moxibustion 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

刘迈兰 

研究负责人:

常小荣 

Applicant:

Mailan Liu 

Study leader:

Xiaorong Chang 

申请注册联系人电话:

Applicant telephone:

18229792024 

研究负责人电话:

Study leader's telephone:

073188458187 

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:

445007305@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xrchang1956@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:

长沙市岳麓区含浦科教园 

研究负责人通讯地址:

长沙市岳麓区含浦科教园 

Applicant address:

Hanpu science and teaching rd, yuelu district, changsha city 

Study leader's address:

Hanpu science and teaching rd, yuelu district, changsha city 

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:

湖南中医药大学 

Applicant's institution:

Hunan university of chinese medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

研究实施负责(组长)单位:

湖南中医药大学 

Primary sponsor:

Hunan university of chinese medicine 

研究实施负责(组长)单位地址:

长沙市岳麓区含浦科教园 

Primary sponsor's address:

Hanpu science and teaching area, yuelu district, changsha city, hunan province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南

市(区县):

Country:

China

Province:

hunan

City:

单位(医院):

湖南中医药大学第一附属医院

具体地址:

长沙市雨花区韶山中路95号

Institution
hospital:

the 1st affiliated hospital of hunan university of chinese medicine

Address:

shaoshan rd, 95#, yuhua district, changsha city

经费或物资来源:

正在申请阶段 

Source(s) of funding:

applying funding 

研究疾病:

新型冠状病毒肺炎 

Target disease:

Novel coronavirus pneumonia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

预实验 

Study phase:

Polit 

研究目的:

以期艾灸能缓解隔离人群的心理、生理的不良变化,甚至减少新冠肺炎的新发病例或严重程度。 

Objectives of Study:

Research on moxibustion can alleviate the adverse psychological and physical changes of isolated people, and even reduce the new cases or severity of NCP, and provide evidence support for home medical observation of isolated people using moxibustion. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)18岁≦年龄≦75岁; (2)符合其中一条及以上者: ① 近1个月有新型冠状病毒感染肺炎确诊患者的接触史; ② 近1个月曾在武汉或发病区域居住或者逗留者; ③ 近1个月与湖北归来人员有密切往来者; ④ 属于确诊2例及以上新型冠状病毒感染肺炎的居住或工作区域内人群者; ⑤ 与新冠肺炎确诊病例乘坐同一交通工具并有近距离接触人员,包括在交通工具上照料护理过病人的人员,该病人的同行人员(家人、同事、朋友等); (3)地域限定为湖南省内; (4)自愿参加本项研究,并签署知情同意书。 同时符合以上4项的患者,方可纳入本项研究。 

Inclusion criteria

(1) 18 years old ≦ age ≦ 75 years old; (2) Those that meet one or more of the following: ①In the past 1 month, there is a history of contact with patients with pneumonia diagnosed by NCP ② People who have lived or stayed in Wuhan or the affected area in the past 1 month; (3) Those who have had close contacts with returnees from Hubei in the past 1 month; ④ Persons who live or work in 2 or more confirmed cases of NCP; ⑤Take the same transportation with the newly diagnosed cases of NCP and have close contact with people, including those who have taken care of the patient on the transportation and the patient's colleagues (family, colleagues, friends, etc.) (3) The area is limited to Hunan Province; (4) Voluntarily participate in this research and sign the informed consent. Participants who meet the above 4 items can be included in this study. 

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)不愿意接受艾灸者,或者对艾灸或代温灸膏过敏者; (7)正在参加其它临床试验者。 凡符合上述任何一条的患者,均予以排除。 

Exclusion criteria:

(1) Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system; (2) Those with malignant changes in the lungs; (3) Persons with a mental, intellectual or language impairment; (4) pregnant women, lactating women and those who have pregnancy requirements in the last 6 months; (5) Those who are unable to fill in the questionnaire materials using mobile phones, computers, etc .; (6) Those who are unwilling to receive moxibustion, or who are allergic to moxibustion or Wenwen cream; (7) Those who are participating in other clinical trials. Participants who meet any of the above are excluded. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-12-31 

干预措施:

Interventions:

组别:

艾灸组

样本量:

100

Group:

moxa

Sample size:

干预措施:

艾灸疗法

干预措施代码:

moxa

Intervention:

moxibustion

Intervention code:

组别:

常规组

样本量:

100

Group:

common

Sample size:

干预措施:

常规观察

干预措施代码:

control

Intervention:

common observation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

hunan 

City:

 

单位(医院):

湖南中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

the 1st affiliated hospital of hunan university of chinese medicine  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

心理量表

指标类型:

主要指标 

Outcome:

Questionaire

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

计算机产生随机序列表,由研究总设计人负责随机方案的分配

性别:

男性

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

The computer generates a random sequence list, and the research designer is responsible for the allocation of the random scheme.

Gender:

Male

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

网络平台还在建设之中。共享原始数据将在试验完成之后,2020.05.31

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

The network platform is still under construction. Sharing of raw data will be completed after the trial, 2020.05.31

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

采用网络平台的后台数据库

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Background database using network platform

创建人:

Creater Name:

 2020-02-18
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