今天是:2020-07-07 星期二

固表解毒灵预防儿童新型冠状病毒肺炎(COVID-19)的临床研究
下载XML文档

注册号:

Registration number:

ChiCTR2000029487 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

固表解毒灵预防儿童新型冠状病毒肺炎(COVID-19)的临床研究 

Public title:

Clinical Study for Gu-Biao Jie-Du-Ling in Preventing of Novel Coronavirus Pneumonia (COVID-19) in Children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

固表解毒灵预防儿童新型冠状病毒肺炎(COVID-19)的临床研究 

Scientific title:

Clinical Study for Gu-Biao Jie-Du-Ling in Preventing of Novel Coronavirus Pneumonia (COVID-19) in Children 

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:

 

申请注册联系人:

苏文 

研究负责人:

苏文 

Applicant:

Su Wen 

Study leader:

Su Wen 

申请注册联系人电话:

Applicant telephone:

+86 13659897175 

研究负责人电话:

Study leader's telephone:

+86 13659897175 

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:

784404524@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

784404524@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:

湖北省武汉市硚口区中山大道215号 

研究负责人通讯地址:

湖北省武汉市硚口区中山大道215号 

Applicant address:

215 Zhongshan Avenue, Qiaokou District, Wuhan, Hubei, China 

Study leader's address:

215 Zhongshan Avenue, Qiaokou District, Wuhan, Hubei, 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:

武汉市中西医结合医院 

Applicant's institution:

Wuhan Hospital of Integrated Traditional Chinese and Western Medicine 

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:

武卫一院伦审[2020]2号 

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:

武汉市第一医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Wuhan 1st Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-01 

伦理委员会联系人:

张琼 

Contact Name of the ethic committee:

Zhang Qiong 

伦理委员会联系地址:

湖北省武汉市硚口区中山大道215号 

Contact Address of the ethic committee:

215 Zhongshan Avenue, Qiaokou District, Wuhan, Hubei, 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:

武汉市中西医结合医院 

Primary sponsor:

Wuhan Hospital of Integrated Traditional Chinese and Western Medicine 

研究实施负责(组长)单位地址:

湖北省武汉市硚口区中山大道215号 

Primary sponsor's address:

215 Zhongshan Avenue, Qiaokou District, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市中西医结合医院

具体地址:

湖北省武汉市硚口区中山大道215号

Institution
hospital:

Wuhan Hospital of Integrated Traditional Chinese and Western Medicine

Address:

215 Zhongshan Avenue, Qiaokou District

经费或物资来源:

武汉市中西医结合医院 

Source(s) of funding:

Wuhan Hospital of Integrated Traditional Chinese and Western Medicine 

研究疾病:

儿童新型冠状病毒肺炎(COVID-19) 

Target disease:

novel coronavirus pneumonia (COVID-19) in children 

研究疾病代码:

 

Target disease code:

 

研究类型:

预防性研究 

Study type:

Prevention 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评估固表解毒灵加减对预防儿童新型冠状病毒感染的肺炎(COVID-19)的临床疗效。 

Objectives of Study:

To evaluate the clinical efficacy of Gubiaojieduling addition and subtraction on prevention of pneumonia in children with COVID-19 infection. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1-18岁且符合中医体质学说中的平和质的健康儿童: (1)主要特征:以体态适中,面色红润,精力充沛等; (2)常见表现:体形匀称,面色、肤色润泽,头发稠密有光泽,目光有神,鼻色明润,嗅觉通利,唇色红润,不易疲劳,精力充沛,耐受寒热,睡眠良好,胃纳佳,二便正常,舌色淡红,苔薄白,脉和缓有力,指纹淡紫隐隐达风关。性格活泼开朗。平素患病较少。 

Inclusion criteria

Healthy children between the ages of 1 and 18 who meet the TCM constitutional doctrine: (1) Main features: moderate body shape, ruddy complexion, energetic, etc .; (2) Common manifestations: Symmetric body shape, complexion, moisturized complexion, thick and shiny hair, bright eyes, clear nose, moist olfactory, rosy lips, not easy to fatigue, energetic, cold and heat tolerance, good sleep, stomach Najia, the second stool is normal, the tongue is reddish, the moss is thin and white, the veins are gentle and strong, and the fingerprint is faint purple. Lively and cheerful character. Usual disease is less common. 

排除标准:

①临床疑似或确诊病例[参考湖北省儿童新型冠状病毒(2019-nCoV)感染诊疗建议(试行第一版)]; ②己接受其他中药、中成药或免疫调节剂等预防新型冠状病毒肺炎者; ③近12周参加其他药物临床试验者; ④合并有其他严重的原发性疾病如心脑血管疾病、肝肾或造血系统疾病、遗传代谢疾病者; ⑤已知对本试验用药物及其成分过敏者; 

Exclusion criteria:

1. Clinical suspected or confirmed cases [Refer to the recommendations for diagnosis and treatment of 2019-nCoV infection in children in Hubei Province (trial version 1)] 2. Those who have received other traditional Chinese medicine, proprietary Chinese medicines or immunomodulators to prevent new coronavirus pneumonia; 3. Participants in clinical trials of other drugs in the past 12 weeks; 4. People with other serious primary diseases such as cardiovascular and cerebrovascular diseases, liver and kidney or hematopoietic diseases, genetic metabolic diseases; 5. Those who are known to be allergic to the test drug and its ingredients; 6. Other constitutions in TCM constitution theory. 

研究实施时间:

Study execute time:

From2020-02-10To 2020-03-31 

干预措施:

Interventions:

组别:

A组 实验组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

隔离+口服固表解毒灵中药

干预措施代码:

Intervention:

Isolation and oral Gubiao Jiedu Ling Chinese medicine

Intervention code:

组别:

B组 对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

隔离

干预措施代码:

Intervention:

Isolated observation

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 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市中西医结合医院 

单位级别:

三级甲等 

Institution
hospital:

Wuhan Hospital of Integrated Traditional Chinese and Western Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

体温

指标类型:

主要指标 

Outcome:

body temperature

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全血细胞计数与五分类

指标类型:

主要指标 

Outcome:

Whole blood count and five classifications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

C-reactive protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咳嗽

指标类型:

次要指标 

Outcome:

cough

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部CT

指标类型:

次要指标 

Outcome:

Lung CT

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:

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):

第三方使用随机数表进行随机分组

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

Third party uses random number table for random grouping

盲法:

未说明

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:

即时公开/Real time access

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):

医院官方网站公布:http://www.whyyy.com.cn

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

Official website of the hospital:http://www.whyyy.com.cn

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-02-02
返回列表