Study for the key technique of integrative therapy of Novel Coronavirus Pneumonia (COVID-19): the TCM symptoms and treatment regulation

注册号:

Registration number:

ITMCTR2000003076

最近更新日期:

Date of Last Refreshed on:

2020-03-02

注册时间:

Date of Registration:

2020-03-02

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

新型冠状病毒肺炎(COVID-19)联合治疗关键技术的中医证治规律研究

Public title:

Study for the key technique of integrative therapy of Novel Coronavirus Pneumonia (COVID-19): the TCM symptoms and treatment regulation

注册题目简写:

English Acronym:

研究课题的正式科学名称:

新型冠状病毒感染肺炎联合治疗关键技术研究 ——新型冠状病毒肺炎中医证治规律研究

Scientific title:

Key techniques of combination therapy of Novel Coronavirus Pneumonia (COVID-19) - Study on TCM symptoms and treatment law

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

2020年山东省重点研发计划(2020SFXGFY04-1)

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:

ChiCTR2000030468 ; ChiMCTR2000003076

申请注册联系人:

朱雪

研究负责人:

张伟

Applicant:

Zhu Xue

Study leader:

Zhang Wei

申请注册联系人电话:

Applicant telephone:

+86 15966680922

研究负责人电话:

Study leader's telephone:

+86 13505319899

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:

zhu-99@163.com

研究负责人电子邮件:

Study leader's E-mail:

zhagnweijinan@126.com

申请单位网址(自愿提供):

Study leader's 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:

山东省济南市文化西路42号

研究负责人通讯地址:

山东省济南市文化西路42号

Applicant address:

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, China

Study leader's address:

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, 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:

山东中医药大学附属医院

Applicant's institution:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

(2020)伦理第(001)号——KY

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

山东中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics committee of Affiliated Hospital of Shandong University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2020/2/28 0:00:00

伦理委员会联系人:

张鑫

Contact Name of the ethic committee:

Zhang Xin

伦理委员会联系地址:

山东省济南市经十路16369号

Contact Address of the ethic committee:

16369 Jingshi Road, Ji'nan, Shandong, 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:

山东中医药大学附属医院

Primary sponsor:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

山东省济南市文化西路42号

Primary sponsor's address:

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, 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):

山东省

市(区县):

济南市

Country:

China

Province:

Shandong

City:

Ji'nan

单位(医院):

山东中医药大学附属医院

具体地址:

山东省济南市文化西路42号

Institution
hospital:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address:

42 Wenhua Road West, Lixia District

经费或物资来源:

2020年山东省重点研发计划(2020SFXGFY04-1)

Source(s) of funding:

Key R & D Plan of Shandong Province in2020 (2020SFXGFY04-1)

研究疾病:

新型冠状病毒肺炎(COVID-19)

研究疾病代码:

Target disease:

Novel Coronavirus Pneumonia (COVID-19)

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

非随机对照试验

Non randomized control

研究所处阶段:

Study phase:

其它

Others

研究目的:

观察中药对该病的预防作用。探讨新型冠状病毒肺炎确诊患者的中医临床证候特点和演变规律的。在确诊患者中辨证论治使用中药治疗,观察其在改善发热等症状、影像学吸收、核酸检测转阴时间等方面的作用。并随访经中医药治疗的患者恢复期并发症及生活质量情况。

Objectives of Study:

Observe the preventive effect of Chinese medicine on the Novel Coronavirus Pneumonia (COVID-19) in close contacts. Explore the characteristics and evolution of TCM clinical syndromes in patients with COVID-19. Differentiate and treat Chinese medicine with diagnosed patients, and observe its role in improving fever and other symptoms, chest CT inflammation absorption, and negative time of nucleic acid detection. To observe the complications and quality of life of patients treated with traditional Chinese medicine after discharge.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1.确诊患者纳入病例标准: (1)符合《新型冠状病毒感染的肺炎诊疗方案(试行第五版)》西医诊断标准; (2)年龄在2岁以上。 2.密切接触者纳入标准: 与病例发病后有如下接触情形之一,但未采取有效防护者: (1)与病例共同居住、学习、工作或其他有密切接触的人员,如与病例近距离工作或共用同一教室或与病例在同一所房屋中生活。 (2)诊疗、护理、探视病例的医护人员、家属或其他与病例有类似近距离接触的人员,如直接治疗及护理病例、到病例所在的密闭环境中探视病人或停留,病例同病室的其他患者及其陪护人员。 (3)与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),经调查评估后发现有可能近距离接触病人的其他乘客和乘务人员。 (4)现场调查人员调查后经评估认为符合其他与密切接触者接触的人员。

Inclusion criteria

1. Criteria for inclusion of confirmed patients: (1) Comply with the diagnostic criteria of "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Pneumonia (COVID-19) (Trial Version 5)"; (2) Above 2 years old; 2. Inclusion criteria for close contacts: One of the following contact situations after the onset of the case, but did not take effective protection: (1) People who live, study, work or have close contact with the case, such as working close to the case or sharing the same classroom or living in the same house as the case; (2) Medical staff, family members, or other people who have close contact with the case, such as direct treatment and care of the case, visiting or staying in the closed environment where the case is located, and the case is the same as other cases in the ward. Patients and their caregivers; (3) People who are in the same transportation as the case and have close contact with them, including those who have taken care of the patient on the transportation, and the patient's colleagues (family, colleagues, friends, etc.) are found to be likely to be near Distance from other passengers and flight attendants who are in contact with the patient; (4) On-site investigators evaluate that they are qualified to meet other contacts with close contacts.

排除标准:

(1)妊娠期患者; (2)合并肝、肾、代谢性疾病; (3)具有其他严重原发性心血管病变、肾脏病变、肝脏病变、血液学改变、或影响其生存质量的严重疾病如恶性肿瘤、艾滋病等; (4)具有或怀疑酒精、药物滥用病史等; (5)精神类疾病或患有狂躁症者,或不愿接受研究措施,或其他原因不愿意合作者; (6)同时参加其他临床研究并影响本调查结果者。

Exclusion criteria:

(1) Patients during pregnancy; (2) Complicated liver, kidney, and metabolic diseases; (3) Have other serious primary cardiovascular disease, kidney disease, liver disease, hematological changes, or serious diseases that affect its quality of life, such as malignant tumors, AIDS, etc.; (4) Have or suspect a history of alcohol, drug abuse, etc.; (5) People with mental illness or manic disorder, or unwilling to accept research measures, or unwilling to cooperate with others; (6) Those who have participated in other clinical studies and influenced the results of this survey.

研究实施时间:

Study execute time:

From 2020-02-28

To      2020-07-30

征募观察对象时间:

Recruiting time:

From 2020-02-28

To      2020-03-31

干预措施:

Interventions:

组别:

TRE-GROUP1

样本量:

100

Group:

TRE-GROUP1

Sample size:

干预措施:

中医辨证治疗+西医治疗

干预措施代码:

Intervention:

TCM syndrome differentiation treatment+ Western medicine treatment

Intervention code:

组别:

PRE-GROUP1

样本量:

400

Group:

PRE-GROUP1

Sample size:

干预措施:

服用中药预防汤剂

干预措施代码:

Intervention:

Taking Chinese medicine preventive decoction

Intervention code:

组别:

TRE-GROUP2

样本量:

50

Group:

TRE-GROUP2

Sample size:

干预措施:

西医治疗

干预措施代码:

Intervention:

Western medicine treatment

Intervention code:

组别:

PRE-GROUP2

样本量:

400

Group:

PRE-GROUP2

Sample size:

干预措施:

一般预防措施

干预措施代码:

Intervention:

General prevention methods

Intervention code:

样本总量 Total sample size : 950

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

山东省

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

山东中医药大学附属医院

单位级别:

三甲医院

Institution/hospital:

Affiliated hospital of shandong university of traditional Chinese medicine

Level of the institution:

Tertiary A Hospital

国家:

中国

省(直辖市):

山东省

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

济南市传染病医院

单位级别:

三级甲等

Institution/hospital:

Jinan Infectious Disease Hospital

Level of the institution:

Tertiary A Hospital

国家:

中国

省(直辖市):

山东省

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

青岛市胸科医院

单位级别:

三级医院

Institution/hospital:

Qingdao Chest Hospital

Level of the institution:

Tertiary Hospital

国家:

中国

省(直辖市):

山东省

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

聊城市传染病医院

单位级别:

三级医院

Institution/hospital:

Liaocheng Infectious Disease Hospital

Level of the institution:

Tertiary Hospital

国家:

中国

省(直辖市):

山东省

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

山东省胸科医院

单位级别:

三甲医院

Institution/hospital:

Shandong Province Chest Hospital

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

胸部影像学

指标类型:

次要指标

Outcome:

Chest imaging

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症几率

指标类型:

次要指标

Outcome:

incidence of complication

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发病率

指标类型:

主要指标

Outcome:

disease incidence

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

次要指标

Outcome:

quality of life

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PCR转阴所需时间

指标类型:

主要指标

Outcome:

Duration of PCR normalization

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证型分布规律

指标类型:

主要指标

Outcome:

Distribution pattern of TCM syndromes

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标

Outcome:

Hospitalization time

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状积分

指标类型:

次要指标

Outcome:

Clinical symptom score

Type:

Secondary 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:

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:

标本中文名:

咽拭子

组织:

Sample Name:

Throat swab

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:

正在进行

Recruiting

年龄范围:

最小
Min age years
最大
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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):

纸质申请

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

Acadimic 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:

病历记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above