Today is 2020-12-01

Screening and prevention of osteonecrosis of the femoral head during novel coronavirus pneumonia (COVID-19) recovery
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注册号:

Registration number:

ChiCTR2000038333 

最近更新日期:

Date of Last Refreshed on:

2020-09-18 

注册时间:

Date of Registration:

2020-09-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)后股骨头坏死风险人群筛选预防研究 

Public title:

Screening and prevention of osteonecrosis of the femoral head during novel coronavirus pneumonia (COVID-19) recovery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎(COVID-19)后股骨头坏死风险人群筛选预防研究 

Scientific title:

Screening and prevention of osteonecrosis of the femoral head during novel coronavirus pneumonia (COVID-19) recovery 

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:

ChiMCTR2000003937 

申请注册联系人:

薛志鹏 

研究负责人:

陈卫衡 

Applicant:

Xue Zhipeng 

Study leader:

Chen Weiheng 

申请注册联系人电话:

Applicant telephone:

+86 15650790003 

研究负责人电话:

Study leader's telephone:

+86 13511013261 

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:

xuezhipeng0504@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chenweiheng@yeah.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 Xiaoguan Street, Andingmen, Chaoyang District, Beijing, China 

Study leader's address:

51 Xiaoguan Street, Andingmen, 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-07 

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:

IRB 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:

Zhao Ying 

伦理委员会联系地址:

北京市朝阳区安定门外小关街51号 

Contact Address of the ethic committee:

51 Xiaoguan Street, Andingmen, Chaoyang District, Beijing, 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:

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:

北京市朝阳区安定门外小关街51号 

Primary sponsor's address:

51 Xiaoguan Street, Andingmen, 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(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:

北京市朝阳区安定门外小关街51号

Institution
hospital:

Beijing University of Chinese Medicine Third Affiliated Hospital

Address:

51 Xiaoguan Street, Andingmen, Chaoyang District

经费或物资来源:

新冠肺炎防控应急专项类横向课题 

Source(s) of funding:

Cross-topic of special emergency for pneumonia prevention and control in COVID-19 

研究疾病:

新型冠状病毒肺炎(COVID-19);股骨头坏死 

Target disease:

Novel Coronavirus Pneumonia (COVID-19); osteonecrosis of the femoral head 

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:

研究目的:

筛选新冠后遗症股骨头坏死高危风险人群,并给予中药预防干预,评价中药预防新冠肺炎后遗症股骨头坏死的有效性和安全性,为激素性股骨头坏死的预防提供有效的方药。 

Objectives of Study:

To screen the high-risk population of osteonecrosis of the femoral head(ONFH) after COVID-19, and give TCM preventive intervention to evaluate the effectiveness and safety of TCM in preventing ONFH after COVID-19, so as to provide an effective prescription for the prevention of steroid-induced ONFH. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.符合新冠病毒肺炎患者恢复后发生股骨头坏死的高风险评价标准; 2.年龄18-70岁; 3.自愿参加临床研究,并自愿签署知情同意书。 

Inclusion criteria

1. Meet the high risk evaluation standard of osteonecrosis of the femoral head after recovery of COVID-19; 2. Aged 18-70 years old; 3. Voluntary participation in clinical research and voluntary signing of informed consent. 

排除标准:

1.因消化道出血、肠梗阻等禁食水的患者; 2.原有严重脑、心、肝、肾和造血系统等疾病不能配合者,肝功能ALT≥1.5倍正常上限; 3.已知的对干预药物成分过敏者; 4.准备妊娠、妊娠或哺乳期妇女; 5.伴有精神类疾病或其他原因无法配合者。 

Exclusion criteria:

1. Patients who have fasted water due to gastrointestinal bleeding and intestinal obstruction; 2. If the original severe diseases such as brain, heart, liver, kidney and hematopoietic system can't cooperate, the liver function ALT>=1.5 ULN; 3. Those who are known to be allergic to the components of intervention drugs; 4. Prepare pregnant, pregnant or lactating women; 5. Those who are accompanied by mental illness or unable to cooperate for other reasons. 

研究实施时间:

Study execute time:

From2020-09-01To 2021-09-01 

征募观察对象时间:

Recruiting time:

From2020-10-01To 2021-02-01 

干预措施:

Interventions:

组别:

健脾康骨组

样本量:

60

Group:

Jianpi Kanggu Group

Sample size:

干预措施:

健脾康骨颗粒

干预措施代码:

Intervention:

Jianpi Kanggu Granules

Intervention code:

组别:

金天格组

样本量:

60

Group:

Jintiange Group

Sample size:

干预措施:

金天格胶囊

干预措施代码:

Intervention:

Jintiange Capsule

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):

 

Country:

China 

Province:

Hubei 

City:

 

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 Orthopaedic Hospital of Intergrated Traditional Chinese and Western Medicine  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

北京 

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 

单位级别:

三级甲等 

Institution
hospital:

Beijing University of Chinese Medicine Third Affiliated Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

股骨头坏死发病率

指标类型:

主要指标 

Outcome:

Incidence of osteonecrosis of the femoral head

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候疗效指数

指标类型:

次要指标 

Outcome:

TCM syndrome curative effect index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

股骨头坏死中医疗效评价标准

指标类型:

次要指标 

Outcome:

Evaluation criteria of TCM for osteonecrosis of the femoral head

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

一般生命体征

指标类型:

次要指标 

Outcome:

General physical signs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

次要指标 

Outcome:

Electrocardiogram

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室理化指标

指标类型:

次要指标 

Outcome:

Laboratory physical and chemical indicators

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:

尿液

组织:

Sample Name:

Urine

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:

粪便

组织:

Sample Name:

feces

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:

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):

采用中心随机化系统的临床实验管理方法,通过拨打随机化中心的电话(交互语音应答系统)或登陆随机化中心网站,输入受试者ID及其他相应材料,中心随机化系统会将新受试者的信息进行处理,并按照规定的随机化方法进行分组,给出受试者对应的随机号。

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

Adopting the clinical experiment management method of central randomization system, by dialing the telephone number of randomization center (interactive voice response system) or logging on the website of randomization center, and inputting the subject ID and other corresponding materials, the central randomization system will

盲法:

未说明

Blinding:

Not stated

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):

公开发表论文

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

Publicly publish 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:

电子病例登记系统

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

Electronic case registration system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-09-18
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