基于移动互联网络新冠肺炎(COVID-19)艾灸疗法非接触式医患互动诊疗模式构建与应用

注册号:

Registration number:

AMCTR-OCN-20000332 

注册号获得时间:

Date of releasing the registration number:

2020/2/29 17:01:58 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

基于移动互联网络新冠肺炎(COVID-19)艾灸疗法非接触式医患互动诊疗模式构建与应用 

Public title:

Construction and application of non-contact doctor-patient interactive diagnosis and treatment mode of moxibustion therapy for new coronary pneumonia (COVID-19) based on mobile internet 

研究课题的正式科学名称:

基于移动互联网络新冠肺炎(COVID-19)艾灸疗法非接触式医患互动诊疗模式构建与应用 

Scientific title:

Construction and application of non-contact doctor-patient interactive diagnosis and treatment mode of moxibustion therapy for new coronary pneumonia (COVID-19) based on mobile internet 

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:

陈霞 

研究负责人:

周仲瑜 

Applicant:

Xia Chen 

Study leader:

Zhongyu Zhou 

申请注册联系人电话:

Applicant telephone:

18627076139 

研究负责人电话:

Study leader's telephone:

18672308659 

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:

536453733@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

2209447940@qq.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:

湖北省武汉市武昌区花园山4号 

研究负责人通讯地址:

湖北省武汉市武昌区花园山4号 

Applicant address:

No. 4 Huayuan Mountain, Wuchang District, Wuhan City, Hubei Province 

Study leader's address:

No. 4 Huayuan Mountain, Wuchang District, Wuhan City, Hubei Province 

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-C03-01 

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:

Hubei Provincial Hospital of TCM of the ethic committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-17 

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:

湖北省武汉市武昌区花园山4号 

Primary sponsor's address:

No. 4 Huayuan Mountain, Wuchang District, Wuhan City, Hubei 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei Province

City:

Wuhan

单位(医院):

湖北省中医院

具体地址:

湖北省武汉市武昌区花园山4号

Institution
hospital:

HUBEI PROVINCIAL HOSPITAL OF TCM

Address:

No. 4 Huayuan Mountain, Wuchang District, Wuhan City, Hubei Province

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

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:

观察性研究 

Study type:

Observational 

研究所处阶段:

临床预试验 

Study phase:

Clinical pre-test 

研究目的:

以艾灸疗法作为介入,发挥“中医治未病”特色,建立基于移动互联网络新冠肺炎非接触式医患互动诊疗模式并运用。 

Objectives of Study:

Using moxibustion as an intervention,the project's aim is to make full use of TCM advantages“preventive treatment of disease”and establish and apply a non-contact doctor-patient interactive diagnosis and treatment model of new coronary pneumonia based on mobile internet . 

研究设计:

无对照研究 

Study design:

Non-control study 

纳入标准:

①符合医学观察期、轻型(寒湿郁肺证)、普通型(寒湿阻肺证)、恢复期(肺脾气虚证)新冠肺炎诊断标准;②18≤年龄≤65 周岁;③自愿接受至少为期10 天的隔物灸治疗。④自愿受试并遵守医院有关管理规定,能配合完成规定的各项检查。 

Inclusion criteria

① Meet the diagnostic criterias for new coronavirus pneumonia (NCP) during the medical observation period, light type (the syndrome of cold and damp stagnating lungs), ordinary type (the syndrome of lung block by cold and damp), and recovery period (qi deficiency of the spleen and the lung syndrome); ② 18≤age ≤65 years old;10-day spacer ③ Voluntarily received inderect moxibustion for at least 10 days. ④ Voluntarily test and abide by the relevant management regulations of the hospital, and be able to cooperate in completing the various inspections. 

排除标准:

①经研究者判断既往或现在患有疾病可能影响参加试验或研究的转归:严重的肺脏疾病、糖尿病、心脑血管疾病、肝肾疾病、恶性肿瘤、神经精神疾病及其他严重影响生存的疾病等;②患有严重影响免疫系统的疾病:如HIV 感染、脾切除、器官移植术等;③妊娠和哺乳期妇女;④对艾灸或中药过敏,或过敏体质者;⑤高热、烦渴等实热炽盛患者;⑥贴敷局部有皮肤破损,不适宜贴敷;⑦近3 个月内参加过其它临床试验者;⑧研究者认为不适宜参加本临床试验者。 

Exclusion criteria:

① If the researcher judges that a previous or current disease may affect the outcome of participating in the trial or study: severe lung disease, diabetes, cardiovascular and cerebrovascular disease, liver and kidney disease, malignant tumor, neuropsychiatric disease and other diseases that seriously affect survival ② Suffering from diseases that seriously affect the immune system: such as HIV infection, splenectomy, organ transplantation, etc. ③ Pregnant and lactating women; ④ Those who are allergic to moxibustion or Chinese medicine, or allergies; ⑤ Hyperthermia, irritability Patients with intense heat; ⑥ local skin damage caused by the application is not suitable; ⑦ those who have participated in other clinical trials within the past 3 months; ⑧ researchers who are not suitable to participate in this clinical trial. 

研究实施时间:

Study execute time:

From2020-02-01To 2020-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

test grope

Sample size:

干预措施:

常规治疗+隔物灸贴

干预措施代码:

Intervention:

routine treatment+indirect moxibustion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

China 

市(区县):

湖北省 

Country:

Hubei Province 

Province:

武汉市 

City:

Wuhan 

单位(医院):

湖北省中医院 

单位级别:

HUBEI PROVINCIAL HOSPITAL OF TCM 

Institution
hospital:

三甲  

Level of the institution:

Grade Three A Hospital 

测量指标:

Outcomes:

指标中文名:

肺部影像学

指标类型:

主要指标 

Outcome:

pulmonary iconography

Type:

Primary indicator 

指标中文名:

体温

指标类型:

次要指标 

Outcome:

temperature

Type:

Secondary indicator 

指标中文名:

肺部影像学

指标类型:

次要指标 

Outcome:

Pulmonary imaging

Type:

Secondary indicator 

指标中文名:

淋巴细胞

指标类型:

次要指标 

Outcome:

lymphocyte

Type:

Secondary indicator 

指标中文名:

核酸检测结果

指标类型:

次要指标 

Outcome:

Nucleic acid test results

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

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

随机方法(请说明由何人用什么方法产生随机序列):

性别:

男女均可

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

none

Gender:

Both

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

中国中医科学院中医药数据中心记录数据

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

Data recorded by TCM data center of Chinese Academy of traditional Chinese Medicine

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):

中国中医科学院中医药数据中心保存数据

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

Data stored in TCM data center of Chinese Academy of traditional Chinese Medicine

创建人:

Creater Name:

 2020-02-17
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