中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2000030386
最近更新日期： Date of Last Refreshed on：	2020-03-01 03:45:03
注册时间： Date of Registration：	2020-02-18 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	艾灸疗法预防新冠肺炎(COVID-19)的诊疗方案研究
Public title：	Study for moxibustion in the preventing of novel coronavirus pneumonia (COVID-19)
注册题目简写：
English Acronym：
研究课题的正式科学名称：	艾灸疗法预防新冠肺炎(COVID-19)的诊疗方案研究
Scientific title：	Study for moxibustion in the preventing of novel coronavirus pneumonia (COVID-19)
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：	AMCTR-IPN-20000331

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：	+86 18229792024	研究负责人电话： Study leader's telephone：	+86 0731 88458187
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, Hu'nan, China	Study leader's address：	Hanpu Science and Teaching Road, Yuelu District, Changsha, Hu'nan, 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：	湖南中医药大学
Applicant's institution：	Hu'nan University of Chinese Medicine
研究负责人所在单位：	湖南中医药大学
Affiliation of the Leader：	Hu'nan 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 00:00:00
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：

湖南中医药大学

Primary sponsor：

Hu'nan 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, Hu'nan, 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)：	湖南	市(区县)：
Country：	China	Province：	Hu'nan	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：	95 Shaoshan Road, Yuhua District, Changsha

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(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：

0

研究设计：

连续入组

Study design：

Sequential

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.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

Moxibustion intervention study plan for 14 days of NCP close contact with forced home isolation:
Participants inclusion criteria:
1. Aged 18 to 75 years old;
2. Those that meet one or more of the following:
(1)In 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 novel coronavirus infection pneumonia;
5. Take the same transportation with the newly diagnosed cases of Novel 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.);
6. The area is limited to Hunan Province;
7. Voluntarily participate in this research and sign the informed consent.
Patient who meet the above 4 items can be included in this study.
Research Program on Moxibustion Intervention in NCP Home Isolation Population:
1. Aged 18 to 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.
Patient who meet the above 4 items can be included in this study.
Research Program on Moxibustion Intervention in NCP Home Isolation Medical Care Group:
1. Aged 18 to 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 Hu'nan 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：

从 From 2020-02-01 00:00:00至 To 2020-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-03-01 00:00:00 至 To 2020-12-31 00:00:00

干预措施：

Interventions：

组别：	Case series	样本量：	1000
Group：	Case series	Sample size：	1000
干预措施：	艾灸	干预措施代码：
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：	Hu'nan	City：
单位(医院)：		单位级别：
Institution hospital：		Level of the institution：

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
测量时间点：	入组前、入组2周后，入组4周后，入组8周后	测量方法：	问卷
Measure time point of outcome：	pre-study, 2 weeks post-study, 4 weeks post-study, 8 weeks post-study	Measure method：	Questionaire

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
测量时间点：	入组前、入组2周后，入组4周后，入组8周后	测量方法：	问卷
Measure time point of outcome：	pre-study, 2 weeks post-study, 4 weeks post-study, 8 weeks post-study	Measure method：	Questionaire

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
测量时间点：	入组前、入组2周后，入组4周后，入组8周后	测量方法：	问卷
Measure time point of outcome：	pre-study, 2 weeks post-study, 4 weeks post-study, 8 weeks post-study	Measure method：	Questionaire

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
测量时间点：	入组前、入组2周后，入组4周后，入组8周后	测量方法：
Measure time point of outcome：	pre-study, 2 weeks post-study, 4 weeks post-study, 8 weeks post-study	Measure method：

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

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	0	岁 years
最大 Max age	0	岁 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）：

计算机产生随机数字表，随机分配方案由专人负责。

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.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
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-based 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：	网络平台的后台数据库，采集和保存数据
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	To collect and save data by the background database of network platform.
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：	2020-03-01 03:45:03