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于旭东医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。同时,请尽快上传研究计划书及知情同意书模板。 中医合作治疗模式对新型冠状病毒肺炎(COVID-19)患者的临床疗效及免疫功能的影响
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注册号:

Registration number:

ChiCTR2000029788 

最近更新日期:

Date of Last Refreshed on:

2020-02-13 

注册时间:

Date of Registration:

2020-02-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

于旭东医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。同时,请尽快上传研究计划书及知情同意书模板。 中医合作治疗模式对新型冠状病毒肺炎(COVID-19)患者的临床疗效及免疫功能的影响 

Public title:

Traditional Chinese medicine cooperative therapy for patients with novel coronavirus pneumonia (COVID-19): a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医合作治疗模式对新型冠状病毒肺炎(COVID-19)患者的临床疗效及免疫功能的影响 

Scientific title:

Traditional Chinese medicine cooperative therapy for patients with novel coronavirus pneumonia (COVID-19): a randomized controlled trial 

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:

ChiMCTR2000003007 

申请注册联系人:

于旭东 

研究负责人:

张耀圣/商建伟 

Applicant:

Xudong Yu 

Study leader:

Yaosheng Zhang, Jianwei Shang 

申请注册联系人电话:

Applicant telephone:

+86 19801206964 

研究负责人电话:

Study leader's telephone:

+86 18134048843 

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:

yuxudong9942@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zysjsgzs@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:

中国北京市东城区海运仓5号 

研究负责人通讯地址:

中国北京市东城区海运仓5号 

Applicant address:

5 Hai-Yun-Cang Lane, Dongcheng District, Beijing, China 

Study leader's address:

5 Hai-Yun-Cang Lane, Dongcheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100700 

研究负责人邮政编码:

Study leader's postcode:

100700 

申请人所在单位:

北京中医药大学附属东直门医院 

Applicant's institution:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

北京中医药大学附属东直门医院 

Primary sponsor:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

中国北京市东城区海运仓5号 

Primary sponsor's address:

5 Hai-Yun-Cang, Dongcheng 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):

北京中医药大学附属东直门医院

具体地址:

东城区海运仓5号

Institution
hospital:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Address:

5 Hai-Yun-Cang, Dongcheng District

经费或物资来源:

横向课题 

Source(s) of funding:

Horizontal project support 

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:

其它 

Study phase:

N/A 

研究目的:

采用随机对照的研究方法,对新型冠状病毒肺炎(COVID-19)患者随机分为试验组及对照组,通过中医合作治疗模式进行干预,并进行临床疗效的评价及相关实验指标的检测,寻找一种客观有效的新型冠状病毒肺炎(COVID-19)的治疗方法,从而使更多的患者受益。 

Objectives of Study:

Using a randomized controlled research method, patients with new type of coronavirus pneumonia (COVID-19) were randomly divided into experimental groups and control groups. Interventions were conducted through the cooperative Chinese medicine treatment model, and clinical efficacy evaluation and related experimental indicators were tested. An objective and effective treatment for new coronavirus pneumonia (COVID-19), which will benefit more patients. 

药物成份或治疗方案详述:

将符合纳入标准的新型冠状病毒肺炎(COVID-19)随机分为治疗组和对照组。对照组采用西医常规化疗方案;试验组在常规方案治疗的基础上行中医辨证治疗。治疗前后进行临床疗效的评价及相关实验指标的检测,以及中医证候评分的变化。患者在用药期间均禁烟禁酒、禁止食用辛辣刺激类食物。 

Description for medicine or protocol of treatment in detail:

The new coronavirus pneumonia (COVID-19) meeting the inclusion criteria was randomly divided into a treatment group and a control group. The control group was treated with Western medicine conventional chemotherapy regimen; the experimental group was treated with TCM syndrome differentiation based on conventional regimen. Before and after treatment, the clinical curative effect was evaluated and the relevant experimental indicators were tested, as well as the changes in TCM syndrome scores. During the medication period, the patients were prohibited from smoking and drinking, and were not allowed to consume spicy foods. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

① 符合《新型冠状病毒肺炎诊疗方案》的确诊标准,确诊为新型冠状病毒感染的肺炎患者; ② 肺炎严重指数(PSI)分级为Ⅰ~Ⅱ级; ③ 年龄18-80周岁; ④ 已自愿签署知情同意书者; 

Inclusion criteria

1. Meet the diagnostic criteria of the "New Coronavirus Pneumonia Diagnosis and Treatment Scheme", patients with pneumonia confirmed by new coronavirus infection; 2. Pneumonia Severity Index (PSI) grade is I ~ II; 3. Aged 18-80 years; 4. Those who have signed the informed consent voluntarily. 

排除标准:

① 过敏体质和对实验药品过敏者; ② 合并其他恶性肿瘤患者; ③ 血液系统疾病,凝血功能障碍及自身免疫性疾病患者; ④ 合并严重心血管疾病、脑血管疾病,造血系统疾病,神经病患者; ⑤ 试验前3个月参加过其他临床研究者。 

Exclusion criteria:

1. People with allergies and allergies to experimental drugs; 2. Combined with other malignant tumors; 3. Patients with hematological diseases, coagulopathy and autoimmune diseases; 4. Combined with severe cardiovascular diseases, Patients with vascular disease, hematopoietic system disease, and neuropathy; 5. Participated in other clinical researchers 3 months before the trial. 

研究实施时间:

Study execute time:

From2020-03-31To 2020-12-30 

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

西医常规治疗方案

干预措施代码:

Intervention:

Western medicine routine treatment plan

Intervention code:

组别:

治疗组

样本量:

30

Group:

Intervention group

Sample size:

干预措施:

西医常规治疗方案加中医辨证治疗

干预措施代码:

Intervention:

Western medicine routine treatment plan plus TCM syndrome differentiation treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学第一临床医院(东直门医院) 

单位级别:

三级甲等 

Institution
hospital:

The First Clinical Hospital of Beijing University of Chinese Medicine (Dongzhimen Hospital)  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

退热时间

指标类型:

主要指标 

Outcome:

Antipyretic time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咽拭子核酸转阴时间

指标类型:

主要指标 

Outcome:

Pharyngeal swab nucleic acid negative time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

主要指标 

Outcome:

Blood gas analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候评分

指标类型:

主要指标 

Outcome:

Traditional Chinese medicine syndrome score

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:

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:

咽拭子

组织:

Sample Name:

Throat swabs

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 18 years
最大 Max age 80 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):

对符合纳入标准的60名患者按照随机数字表分为治疗组和对照组各30例。

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

Sixty patients who met the inclusion criteria were divided into a treatment group and a control group with 30 cases each according to the random number table.

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

2021年5月 以学术论文的形式

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

May 2021 In the form of academic 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:

我们将应用病例记录表、电子采集和管理系统对研究过程中的数据进行采集和管理

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

We will use case records, electronic collection and management systems to collect and manage data during the research process

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-13
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