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Analysis on the Distribution of TCM Syndromes in convalescent novel coronavirus pneumonia (COVID-19) patients
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注册号:

Registration number:

ChiCTR2000038739 

最近更新日期:

Date of Last Refreshed on:

2020-09-30 

注册时间:

Date of Registration:

2020-09-30 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)患者恢复期的中医证候分布规律分析 

Public title:

Analysis on the Distribution of TCM Syndromes in convalescent novel coronavirus pneumonia (COVID-19) patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于“新型冠状病毒肺炎病例登记系统”的新冠肺炎恢复期与后遗症中医药干预方案研究 

Scientific title:

Study on traditional Chinese Medicine intervention Program of COVID-19 's convalescence and sequelae based on COVID-19 case Registration system 

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:

ChiMCTR2000003991 

申请注册联系人:

张山 

研究负责人:

王成祥 

Applicant:

Shan Zhang 

Study leader:

Chengxiang Wang 

申请注册联系人电话:

Applicant telephone:

+86 17801222680 

研究负责人电话:

Study leader's telephone:

+86 18612922358 

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:

313012270@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wang601@vip.sina.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:

北京市朝阳区安定门外小关街51号 

研究负责人通讯地址:

北京市朝阳区安定门外小关街51号 

Applicant address:

51 Anwai Xiaoguan Street, Chaoyang District, Beijing, China 

Study leader's address:

51 Anwai Xiaoguan Street, Chaoyang District, Beijing, 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:

北京中医药大学第三附属医院 

Applicant's institution:

Beijing University of Chinese Medicine Third Affiliated Hospital 

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:

BZYSY-2020KYKTPJ-06 

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:

北京中医药大学第三附属医院科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the Third Affiliated Hospital of Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-04 

伦理委员会联系人:

赵莹 

Contact Name of the ethic committee:

Ying Zhao 

伦理委员会联系地址:

北京市朝阳区安外小关北里43号渔阳大厦A610 

Contact Address of the ethic committee:

A610, Yuyang Building, 43 Xiaoguan Lane North, Anwai, Chaoyang District, Beijing 

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:

北京中医药大学第三附属医院 

Primary sponsor:

Beijing University of Chinese Medicine Third Affiliated Hospital 

研究实施负责(组长)单位地址:

北京市朝阳区安外小关街51号 

Primary sponsor's address:

51 Anwai Xiaoguan Street, Chaoyang District, Beijing, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学第三附属医院

具体地址:

北京市朝阳区安外小关街51号

Institution
hospital:

Beijing University of Chinese Medicine Third Affiliated Hospital

Address:

51 Anwai Xiaoguan Street, Chaoyang District

经费或物资来源:

北京中医药大学2020年度基本科研业务费项目 

Source(s) of funding:

Beijing University of Traditional Chinese Medicine 2020 Basic Scientific Research Business Expense Project 

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 study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

总结、归纳、分析新型冠状病毒肺炎患者恢复期的中医证候分布规律 

Objectives of Study:

Summarize, summarize and analyze the distribution law of TCM syndromes of COVID-19 patients in convalescence. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.参照国家卫生健康委员建委和国家中医药管理局2020年3月3日联合颁布的《新型冠状病毒肺炎诊疗方案-试行第七版》,符合新冠病毒肺炎恢复期患者。 2.对本研究知情同意,自愿参加研究。 

Inclusion criteria

1. According to the "COVID-19 diagnosis and treatment Plan-trial Seventh Edition" jointly issued by the State Health Commission and the State Administration of traditional Chinese Medicine on March 3, 2020, it is in line with COVID-19 's convalescent patients; 2. Informed consent to this study, volunteer to participate in the study. 

排除标准:

1.正在参加其他临床试验者。 2.原有严重脑、心、肝、肾和造血系统等疾病不能配合者,恶性肿瘤及有精神、神经障碍不能合作者。 

Exclusion criteria:

1. Those who are participating in other clinical trials; 2. Those who cannot cooperate with the original serious diseases such as brain, heart, liver, kidney and hematopoietic system, malignant tumors and mental and neurological disorders can not cooperate. 

研究实施时间:

Study execute time:

From2020-08-01To 2021-08-01 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2021-07-01 

干预措施:

Interventions:

组别:

Case series

样本量:

800

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北六七二中西医结合骨科医院 

单位级别:

三级医院 

Institution
hospital:

Hubei 672 Orthopaedics Hospital of Integrated Chinese and Western Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

证候分布规律

指标类型:

主要指标 

Outcome:

Syndrome distribution law

Type:

Primary 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:

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 years
最大 Max age 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):

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

No

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

2022.2.01,向研究者索取

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

2022.2.01,From the researcher

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:

CRF

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:

有/Yes

注册人:

Name of Registration:

 2020-09-30
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