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中医分期方案治疗新型冠状病毒肺炎(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:

ChiCTR2000029518 

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:

中医分期方案治疗新型冠状病毒肺炎(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 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:

中医分期方案治疗新型冠状病毒肺炎(COVID-19)的前瞻性随机双盲安慰剂对照研究 

Scientific title:

A prospective randomized double-blind placebo-controlled study of traditional Chinese medicine staging regimen in the treatment of 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:

ChiMCTR2000002964 

申请注册联系人:

谢志军 

研究负责人:

温成平 

Applicant:

Xie Zhijun 

Study leader:

Wen Chengping 

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 13906514781 

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:

浙江省杭州市滨江区滨文路548号 

研究负责人通讯地址:

浙江省杭州市滨江区滨文路548号 

Applicant address:

548 Binwen Road, Binjiang District, Hangzhou, Zhejiang  

Study leader's address:

548 Binwen Road, Binjiang District, Hangzhou, Zhejiang 

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13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:

浙江省杭州市滨江区滨文路548号 

Primary sponsor's address:

548 Binwen Road, Binjiang District, Hangzhou, Zhejiang  

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:

滨江区滨文路548号

Institution
hospital:

Zhejiang Chinese Medical University

Address:

548 Binwen Road, Binjiang District

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对2019-nCoV感染病例的治愈时间、缩短平均住院时间、防止普通型进展为重型的比率或重型进展为危重型甚至死亡的比率、临床症状缓解时间;中医证候改善情况等方面的疗效及其安全性。 

Objectives of Study:

A randomized double-blind placebo-controlled clinical trial was conducted to clarify the efficacy and safety of TCM staging in the treatment of 2019-nCoV infection, shortening the average hospital stay, preventing the progression of the common type to severe, the rate of severe progression to critical or even death, the time of remission of clinical symptoms, the improvement of TCM syndromes and so on. 

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。 (三)重型病例的治疗。   1.治疗原则:在对症治疗的基础上,积极防治并发症,治疗基础疾病,预防继发感染,及时进行器官功能支持。   2.呼吸支持:无创机械通气2小时,病情无改善,或患者不能耐受无创通气、气道分泌物增多、剧烈咳嗽,或血流动力学不稳定,应及时过渡到有创机械通气。有创机械通气采取小潮气量“肺保护性通气策略”,降低呼吸机相关肺损伤。必要时采取俯卧位通气、肺复张或体外膜肺氧合(ECMO) 等。   3.循环支持:充分液体复苏的基础上,改善微循环,使用血管活性药物,必要时进行血流动力学监测。   4.其他治疗措施。可根据患者呼吸困难程度、胸部影像学进展情况,酌情短期内(3~5天)使用糖皮质激素,建议剂量不超过相当于甲泼尼龙 1~2mg/kg·d;可静脉给予血必净 100mL/日,每日2次治疗;可使用肠道微生态调节剂,维持肠道微生态平衡,预防继发细菌感染;有条件情况下可考虑恢复期血浆治疗。患者常存在焦虑恐惧情绪,应加强心理疏导。 2. 治疗组 在基本治疗的基础上,加用中药煎剂,组方如下 普通型(中医临床治疗初期): 苍术15g、厚朴9g、藿香10g、草果6g、生麻黄6g、 蝉衣6g、生姜5g、杏仁9g、虎杖15g。水煎后封装,每袋200ml,分早晚两次温服。 重型(中医临床治疗中期): 生麻黄后下9g、石膏30g、杏仁9g、枇杷叶12g、葶苈子12g、 白芥子15g、 莱菔子12g、槟榔9g、生大黄后下6g、虎杖15g。水煎后封装,每袋200ml,分早晚两次温服。 3. 对照组 在基本治疗的基础上,加用模拟中药安慰剂治疗。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。 

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 符合确诊病例普通型(中医临床治疗初期)或确诊病例重型(中医临床治疗中期)诊断标准的患者; ② 确诊病例普通型(中医临床治疗初期)的病例属于寒湿郁肺型; ③ 确诊病例重型(中医临床治疗中期)病例属于疫毒闭肺型; ④ 患者知情并同意参加本研究。 

Inclusion criteria

(1) Patients who meet the diagnostic criteria of the common type of confirmed cases (the initial stage of clinical treatment of traditional Chinese medicine) or the severe cases of confirmed cases (the middle stage of clinical treatment of traditional Chinese medicine); (2) The cases of common type (the initial stage of clinical treatment of traditional Chinese medicine) belong to the type of cold-dampness stagnant lung; (3) The confirmed cases were severe (in the middle stage of clinical treatment of traditional Chinese medicine). (4) The patients knew and agreed to participate in this 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) The critically ill patients in the diagnosis and treatment program of pneumonia with new coronavirus infection issued by the National Health Commission; (2) It is not suitable for patients who take traditional Chinese medicine decoction; (3) Those with other serious organ diseases or mental diseases; (4) Those who are allergic to or have contraindications to the drugs involved in the study scheme. 

研究实施时间:

Study execute time:

From2020-02-04To 2020-04-30 

干预措施:

Interventions:

组别:

(普通型)西医组

样本量:

40

Group:

(ordinary) Western medicine group

Sample size:

干预措施:

采用“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”中的普通型的西药治疗方案治疗

干预措施代码:

Intervention:

Use the (ordinary) western medicine treatment plan in "the diagnosis and treatment plan of new coronavirus infection pneumonia" issued by the National Health Commission of the fourth edition.

Intervention code:

组别:

(普通型)中西医组

样本量:

40

Group:

(ordinary) Chinese and Western Medicine Group

Sample size:

干预措施:

采用“杭州市西溪医院新型冠状病毒感染的肺炎中医医疗救治方案”中的中医临床治疗初期中医处方结合西医组治疗方案治疗

干预措施代码:

Intervention:

Use the (ordinary) TCM clinical prescription combined with the western medicine treatment plan in "the diagnosis and treatment plan of new coronavirus infection pneumonia" issued by the National Health Commission of the fourth edition.

Intervention code:

组别:

(重型)西医组

样本量:

30

Group:

(severe) Western medicine group

Sample size:

干预措施:

采用“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”中的重型的西药治疗方案治疗

干预措施代码:

Intervention:

Use the (severe) TCM clinical prescription combined with the western medicine treatment plan in "the diagnosis and treatment plan of new coronavirus infection pneumonia" issued by the National Health Commission of the fourth edition.

Intervention code:

组别:

(重型)中西医组

样本量:

30

Group:

(severe) Chinese and Western Medicine Group

Sample size:

干预措施:

采用“杭州市西溪医院新型冠状病毒感染的肺炎中医医疗救治方案”中的中医临床治疗中期中医处方结合西医组治疗方案治疗。

干预措施代码:

Intervention:

Use the(severe)TCM clinical prescription combined with the western medicine treatment plan in "the diagnosis and treatment plan of new coronavirus infection pneumonia" issued by the National Health Commission of the fourth edition.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市西溪医院 

单位级别:

三级甲等 

Institution
hospital:

Xixi Hospital of Hangzhou  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

痊愈时间

指标类型:

主要指标 

Outcome:

Recovery 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:

普通型进展为重型的比例及时间

指标类型:

主要指标 

Outcome:

Ratio and time for the general type to progress to heavy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

重型进展为危重型甚至死亡的比率及时间

指标类型:

主要指标 

Outcome:

Ratio and time of severe progression to critical or even death

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候改善情况

指标类型:

次要指标 

Outcome:

Improvement of TCM syndromes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状(发热、乏力、胃肠不适等)缓解情况及缓解时间

指标类型:

次要指标 

Outcome:

Relief of clinical symptoms (fever, fatigue, gastrointestinal discomfort, etc.) and duration

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺HRCT评分改善情况

指标类型:

次要指标 

Outcome:

Lung HRCT score improvement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

平均住院时间

指标类型:

次要指标 

Outcome:

Average length of hospital stay

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生率

指标类型:

次要指标 

Outcome:

Adverse event rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存质量(SF36)

指标类型:

次要指标 

Outcome:

Quality of life (SF 36)

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:

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:

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:

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):

采用分层区组随机法。以2019-nCoV肺炎普通型(中医临床治疗初期)和重型(中医临床治疗中期)2期以及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两组随机号,根据患者的分层,随机分配受试者进入中西医组或西医组。每组均为25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):

A stratified block random method was used. Based on the 2019-nCoV pneumonia general type (early TCM clinical treatment) and heavy (medium TCM clinical treatment) phase 2 and whether there are basic diseases of organ damage as stratification factors, two random numbers are generated through the corresponding randomi

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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