艾灸疗法预防新冠肺炎的诊疗方案研究

注册号:

Registration number:

AMCTR-IPN-20000331 

注册号获得时间:

Date of releasing the registration number:

2020/2/29 16:58:42 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

艾灸疗法预防新冠肺炎的诊疗方案研究 

Public title:

Study on moxibustion for novel coronavirus pneumonia 

研究课题的正式科学名称:

艾灸疗法预防新冠肺炎的诊疗方案研究 

Scientific title:

Study on moxibustion for novel coronavirus pneumonia 

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 Road, Yuelu District, Changsha, Hunan 

Study leader's address:

Hanpu Science and Teaching Road, Yuelu District, Changsha, Hunan 

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:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

HN-LL-KY-2020-002-01 

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:

湖南中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the 1st Affiliated Hospital of Hunan University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-20 

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 Road, Yuelu District, Changsha, Hunan 

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:

正在申请课题阶段 

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:

研究针对密切接触者、普通居家人群及医务工作者预防新冠肺炎的艾灸方案 

Objectives of Study:

Study on moxibustion programs for close contacts, population stay at home and medical workers to prevent NCP. 

研究设计:

无对照研究 

Study design:

Non-control study 

纳入标准:

一、艾灸干预NCP密切接触强制居家隔离14天的研究方案 (一)研究对象 1.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。 二、艾灸干预NCP居家隔离人群的研究方案 (一)研究对象 1.纳入标准: (1)18岁≦年龄≦75岁; (2)符合其中一条及以上者: ① 近一个月没有新型冠状病毒感染肺炎确诊患者的接触史; ② 素体虚弱,易感风寒,有呼吸系统慢性病史; (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。 三、艾灸干预NCP居家隔离医护人群的研究方案 (一)研究对象 1.纳入标准: (1)18岁≦年龄≦75岁; (2)符合其中一条及以上者: ① 职业为医患人员; ② 近1个月没有新型冠状病毒感染肺炎确诊患者的接触史; (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

I. Moxibustion intervention study plan for 14 days of NCP close contact with forced home isolation (I) Research participants 1. 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 new coronavirus; ② People who have lived or stayed in Wuhan or the affected area in the past month; (3) Those who have had close contacts with returnees from Hubei in the past month; ④ Persons who live or work in 2 or more confirmed cases of new coronavirus infection pneumonia; ⑤Take the same transportation with the newly diagnosed cases of New Coronary Pneumonia 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. Research Program on Moxibustion Intervention in NCP Home Isolation Population (I) Research participants 1. Inclusion criteria: (1) 18 years old ≦ age ≦ 75 years old; (2) Those that meet one or more of the following: ① There is no contact history of patients with pneumonia diagnosed with new-type coronavirus in the past month; ② The corpus callosum is weak, susceptible to wind and cold, and has a history of chronic respiratory diseases; (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. Research Program on Moxibustion Intervention in NCP Home Isolation Medical Care Group (I) Research participants 1. Inclusion criteria: (1) 18 years old ≦ age ≦ 75 years old; (2) Those that meet one or more of the following: ① Occupation is doctor and patient; ② There is no contact history of patients with pneumonitis diagnosed with new-type coronavirus in the past 1 month; (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. Patients 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:

1000

Group:

moxa

Sample size:

干预措施:

艾灸

干预措施代码:

moxa

Intervention:

moxibustion

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):

湖南省内招募 

单位级别:

无 

Institution
hospital:

hunan province  

Level of the institution:

no 

测量指标:

Outcomes:

指标中文名:

心理情绪评估

指标类型:

主要指标 

Outcome:

mood assessment

Type:

Primary indicator 

指标中文名:

症状自评量表

指标类型:

次要指标 

Outcome:

self-assessment scale

Type:

Secondary indicator 

指标中文名:

艾灸相关问卷

指标类型:

次要指标 

Outcome:

moxa related Questionaire

Type:

Secondary indicator 

指标中文名:

新冠肺炎情况表

指标类型:

次要指标 

Outcome:

NCP related issues

Type:

Secondary 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):

计算机产生随机数字表,随机分配方案由专人负责。

性别:

男性

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

A table of random numbers is generated by the computer, and the random distribution scheme is the responsibility of a special person.

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,2020.07.31

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, 2020.07.31

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):

网络平台的后台数据库,采集和保存数据

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

To collect and save data by the background database of network platform.

创建人:

Creater Name:

 2020-02-18
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