今天是:2020-07-07 星期二

中医防治疑似新型冠状病毒肺炎(COVID-19)的前瞻性随机双盲安慰剂对照研究
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注册号:

Registration number:

ChiCTR2000029517 

最近更新日期:

Date of Last Refreshed on:

2020-02-12 

注册时间:

Date of Registration:

2020-02-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医防治疑似新型冠状病毒肺炎(COVID-19)的前瞻性随机双盲安慰剂对照研究 

Public title:

Chinese medicine prevention and treatment program for suspected novel coronavirus pneumonia (COVID-19): a perspective, double-blind, placebo, randomised controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医分期方案防治2019新型冠状病毒肺炎(COVID-19)的RCT临床联合研究方案 

Scientific title:

Chinese medicine prevention and treatment program for novel coronavirus pneumonia (COVID-19) 

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:

ChiMCTR2000002963 

申请注册联系人:

谢志军 

研究负责人:

温成平 

Applicant:

Zhijun Xie 

Study leader:

Chengping Wen 

申请注册联系人电话:

Applicant telephone:

+86 13757132498 

研究负责人电话:

Study leader's telephone:

+86 13601331063 

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:

xzj575@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wengcp@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:

浙江省杭州市滨文路548号 

研究负责人通讯地址:

浙江省杭州市滨文路548号 

Applicant address:

548 Binwen Road, Hangzhou, Zhejiang, China 

Study leader's address:

548 Binwen Road, Hangzhou, Zhejiang, 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:

浙江中医药大学 

Applicant's institution:

Zhejiang Chinese Medical University 

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:

2020年(科)伦审第12号 

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:

杭州市西溪医院(杭州市第六人民医院)伦理委员 

Name of the ethic committee:

Medical Ethics Committee of Hangzhou Xixi Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-02 

伦理委员会联系人:

李兆翌 

Contact Name of the ethic committee:

Zhaoli Li 

伦理委员会联系地址:

中国浙江省杭州市西湖区留下镇横埠街2号 

Contact Address of the ethic committee:

2 Hengbu Street, Liuxia Town, Xihu District, Hangzhou, Zhejiang, 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:

浙江中医药大学 

Primary sponsor:

Zhejiang Chinese Medical University 

研究实施负责(组长)单位地址:

浙江省杭州市滨文路548号 

Primary sponsor's address:

548 Binwen Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江中医药大学

具体地址:

滨文路548号

Institution
hospital:

Zhejiang Chinese Medical University

Address:

548 Binwen Road

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

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:

探索性研究/预试验 

Study phase:

研究目的:

通过随机双盲安慰剂对照临床试验,明确中医药分期方案在预防2019-nCoV感染的疑似病例进展为2019-nCoV肺炎、缩短痊愈时间、减轻确诊病例的临床症状、减少危重症发生率方面的疗效及安全性。 

Objectives of Study:

Randomized double-blind placebo-controlled clinical trials were conducted to identify the efficacy and safety of TCM staging regimens in preventing the progression of 2019-ncov pneumonia from suspected cases of 2019-ncov infection, shortening the recovery time, reducing the clinical symptoms of confirmed cases, and reducing the incidence of critical illness. 

药物成份或治疗方案详述:

1.基本治疗 基本治疗根据“国家卫健委印发第四版新型冠状病毒感染的肺炎诊疗方案”制定,具体如下: (一) 根据病情严重程度确定治疗场所。 疑似病例应在具备有效隔离条件和防护条件的定点医院隔离治疗,疑似病例应单人单间隔离治疗,确诊病例可多人收治在同一病室。 (二)一般治疗。 1.卧床休息,加强支持治疗,保证充分热量;注意水、电解质平衡,维持内环境稳定;密切监测生命体征、指氧饱和度等。 2.根据氧饱和度的变化,及时给予有效氧疗措施,包括鼻导管、面罩给氧,必要时经鼻高流量氧疗、无创或有创机械通气等。 3.抗病毒治疗:可试用α-干扰素雾化吸入(成人每次500万U,加入灭菌注射用水2ml,每日2次);洛匹那韦/ 利托那韦(200mg/50mg,每粒)每次2 粒,每日二次。 4.抗菌药物治疗:避免盲目或不恰当使用抗菌药物,尤其是联合使用广谱抗菌药物。加强细菌学监测,有继发细菌 感染证据时及时应用抗菌药物。 2.治疗组 在基本治疗的基础上,加用中药煎剂,组方如下: 藿香9g、厚朴9g、银花9g、苍术9g、蝉衣6g、苏叶6g、茯苓15g、淮山药15g。水煎后封装,每袋200ml,分早晚两次温服。 若纳差者,加白扁豆9g,六神曲15g;恶寒头痛者,加羌活9g,葛根15g;胸闷咳嗽明显者,加生麻黄6g,杏仁9g。 3.对照组 中药煎剂安慰剂治疗。颜色气味味道与上述的中药煎剂基本保持一致,每袋200ml,分早晚两次温服。 疗程: 治疗观察期3-5天,解除隔离/出院或进展为新型冠状病毒(2019-nCoV)肺炎确诊病例后再随访14天。 

Description for medicine or protocol of treatment in detail:

Treatment: Basic treatment The basic treatment is formulated according to the "National Health and Medical Commission's fourth edition of the diagnosis and treatment of pneumonia caused by new coronavirus infection", as follows: (1) Determine the treatment place according to the severity of the disease. Suspected cases should be isolated and treated in designated hospitals with effective isolation and protective conditions. Suspected cases should be treated in isolation and in single rooms. Multiple confirmed cases can be admitted to the same ward. (B) General treatment. 1. Rest in bed, strengthen supportive treatment to ensure sufficient heat; pay attention to water and electrolyte balance to maintain internal environment stability; closely monitor vital signs, oxygen saturation, etc. 2. According to the changes in oxygen saturation, timely provide effective oxygen therapy measures, including nasal catheter, mask oxygen, transnasal high-flow oxygen therapy, non-invasive or invasive mechanical ventilation if necessary. 3. Antiviral therapy: try alpha-interferon inhalation (5 million U each time for adults, add 2ml of sterile water for injection twice daily); lopinavir / ritonavir 200mg / 50mg, 2 capsules each time, twice daily. 4. Antibacterial drug treatment: Avoid blind or inappropriate use of antibacterial drugs, especially the combination of broad-spectrum antibacterial drugs. Strengthen bacteriological surveillance, and promptly apply antibacterial drugs when there is evidence of secondary bacterial infection. Treatment group On the basis of basic treatment, add Chinese medicine decoction, the formula is as follows: Huoxiang 9g, Magnolia 9g, Yinhua 9g, Atractylodes 9g, Cicada 6g, Su Ye 6g, Poria 15g, Huai yam 15g. Package after decoction, 200ml per bag, warm twice daily. If the appetite is poor, add 9g of white lentils and 15g of Liushenqu. For those with aching headaches, add 9g of pupa live and 15g of kudzu root. For those with obvious chest tightness and cough, add raw ephedra 6g and almond 9g. Control group Chinese medicine decoction placebo treatment. The color, smell and taste are basically consistent with the above-mentioned traditional Chinese medicine decoction, 200ml per bag, and warmed twice in the morning and evening. Course of treatment The treatment observation period was 3-5 days, followed by a 14-day follow-up after isolation / discharge or progress to a confirmed case of new coronavirus (2019-nCoV) pneumonia. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

① 符合“国家卫健委印发第四版新型冠状病毒感染的肺炎诊疗方案”中的疑似病例(中医医学观察期)诊断标准的患者; ② 年龄在14岁至80岁之间者。 ③ 患者知情并同意参加本研究。 

Inclusion criteria

(1) Conforming to the diagnostic criteria of suspected cases (Chiese medicine observation period) in the fourth edition of pneumonia diagnosis and treatment program for new coronavirus infection issued by the national health and health commission; (2) Age between 14 and 80 years old; (3) Patients informed and agreed to participate in the study. 

排除标准:

① 不适合服用中药煎剂的患者。 ② 有其他严重脏器病变者或精神类疾病者; ③ 对研究方案中涉及的药物过敏或有使用禁忌者。 

Exclusion criteria:

(1) Patients are not suitable to take Chinese medicine decoction. (2) Patients have other serious organ disease or mental illness; (3) Patients allergy or have contraindications to the drugs involved in the research program. 

研究实施时间:

Study execute time:

From2020-02-04To 2020-04-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

50

Group:

treament group

Sample size:

干预措施:

中药煎剂

干预措施代码:

Intervention:

Chinese medicine decoction

Intervention code:

组别:

安慰剂组

样本量:

50

Group:

placebo group

Sample size:

干预措施:

中药煎剂安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

杭州 

市(区县):

 

Country:

China 

Province:

Hangzhou 

City:

 

单位(医院):

浙江中医药大学附属杭州市西溪医院 

单位级别:

三甲 

Institution
hospital:

Hangzhou Xixi Hospital Affiliated to Zhejiang Chinese Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床症状缓解情况及缓解时间

指标类型:

主要指标 

Outcome:

Relief of clinical symptoms and duration

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

进展为2019-nCoV肺炎的比率

指标类型:

次要指标 

Outcome:

Progression rate of 2019-nCoV pneumonia

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

进展为2019-nCoV肺炎者发生重症肺炎或死亡的比率

指标类型:

次要指标 

Outcome:

Rate of severe pneumonia or death in people who progress to 2019-nCoV pneumonia

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:

标本中文名:

下呼吸道标本

组织:

Sample Name:

ower respiratory tract specimens

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 14 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):

采用分层随机法。以是否有脏器损伤的基础疾病作为分层因素,通过 SAS软件的相应随机化程序产生一组随机号,随机分配受试者进入中医治疗组,安慰剂组。每组均为50例受试者。SAS随机化程序相关参数及结果由试验设计单位保存。

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

Use stratified random method. Taking the underlying disease of organ damage as a stratification factor, a set of random numbers were generated through the corresponding randomization procedure of SAS software, and the subjects were randomly assigned to the TCM treatment group and the placebo group.

盲法:

本研究按照双盲临床试验规范化操作步骤,对试验药和对照药进行重新包装和分配,包括应急信件。

Blinding:

Double blind.

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):

lcblcjsystem.zcmu.edu.cn

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

lcblcjsystem.zcmu.edu.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:

病例记录表和电子采集和管理系统

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

CRF and EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-03
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