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Efficacy of Liu-zi-jue in Patients with 2019 Novel Coronavirus Pneumonia (COVID-19): a randomized controlled trial
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注册号:

Registration number:

ChiCTR2000033318 

最近更新日期:

Date of Last Refreshed on:

2020-05-28 

注册时间:

Date of Registration:

2020-05-27 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

六字防治新型冠状病毒性肺炎(COVID-19)患者的随机临床对照试验研究 

Public title:

Efficacy of Liu-zi-jue in Patients with 2019 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:

中医传统功法防控新冠肺炎(COVID-19)技术应用研究 

Scientific title:

Rqesearch on the Application of Traditional Chinese Medicine Traditional Techniques to Prevent and Control New Coronary Pneumonia 

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:

ChiMCTR2000003348 

申请注册联系人:

张帅攀 

研究负责人:

房敏 

Applicant:

Shuaigpan Zhang 

Study leader:

Min Fang 

申请注册联系人电话:

Applicant telephone:

+86 18939061729 

研究负责人电话:

Study leader's telephone:

+86 18930568005 

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:

18939061729@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fangmin19650510@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

Shanghai University of Traditional 

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:

上海市虹口区甘河路110号上海中医药大学附属岳阳中西医结合医院  

研究负责人通讯地址:

上海市虹口区甘河路110号上海中医药大学附属岳阳中西医结合医院  

Applicant address:

110 Ganhe Road, Hongkou District, Shanghai, China 

Study leader's address:

110 Ganhe Road, Hongkou District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200437 

研究负责人邮政编码:

Study leader's postcode:

200437 

申请人所在单位:

上海中医药大学附属岳阳中西医结合医院 

Applicant's institution:

Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese 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:

2020-002-01 

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:

上海中医药大学附属岳阳中西医结合医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-18 

伦理委员会联系人:

殷从全 

Contact Name of the ethic committee:

Congquan Yin 

伦理委员会联系地址:

上海市虹口区甘河路110号上海中医药大学附属岳阳中西医结合医院  

Contact Address of the ethic committee:

110 Ganhe Road, Hongkou District, Shanghai, 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:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor:

Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor's address:

110 Ganhe Road, Hongkou District, Shanghai, 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):

上海

市(区县):

上海

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road, Hongkou District, Shanghai

经费或物资来源:

上海中医药大学抗疫应急攻关项目 

Source(s) of funding:

Anti-epidemic emergency research project of Shanghai University of Traditional Chinese Medicine 

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:

观察六字诀结合常规治疗对于新型冠状病毒肺炎患者的临床疗效  

Objectives of Study:

Observe the clinical effect of Liuzijue combined with conventional treatment on patients with new coronavirus pneumonia  

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)对性别和年龄没有限制; (2)被诊断为轻度肺炎(临床症状轻微,影像学无肺炎表现),普通肺炎患者(发烧,呼吸道症状等,影像学显示为肺炎但无多器官损害); (3)住院患者; (4)自愿参加试验并签署“知情同意书” (5)保证不进行其他运动治疗。 

Inclusion criteria

(1) There is no restrictions on gender and age; (2) Patients diagnosed with mild pneumonia (slight clinical symptoms, no pneumonia manifestations on imaging), general pneumonia patients (with fever, respiratory tract symptoms, etc., imaging showed pneumonia but no multiple organ damage); (3) Hospitalized patients; (4) Volunteer to join the trial and sign the "informed consent; (5) Promise not to perform other exercise activities.  

排除标准:

(1)患有严重疾病如心血管,脑血管,造血,消化系统或精神疾病的患者; (2)孕妇和哺乳期妇女; (3)呼吸频率> 30次/ min,显示呼吸衰竭; (4)并发其他器官衰竭需要呼吸重症监护病房(ICU)进行治疗; (5)不想参加试验的人。  

Exclusion criteria:

(1) patients with severe diseases such as cardiovascular, cerebrovascular, hematopoietic, digestive system or mental illness; (2) pregnant and lactating women; (3) respiratory frequency> 30 times /min, showing respiratory failure; (4) complicated with other organ failure requires treatment by respiratory intensive care unit (ICU); (5) those who do not want to join the trial.  

研究实施时间:

Study execute time:

From2020-02-20To 2020-12-30 

干预措施:

Interventions:

组别:

干预组

样本量:

52

Group:

Experimental group

Sample size:

干预措施:

常规治疗+六字诀训练

干预措施代码:

Intervention:

Conventional treatment plus Liu--zi-jue exercise therapy

Intervention code:

组别:

对照组

样本量:

52

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

虹口区 

Country:

China 

Province:

Shanghai 

City:

Hongkou 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

黄石市中医院 

单位级别:

三甲医院 

Institution
hospital:

Huangshi City Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

改良呼吸困难量表

指标类型:

主要指标 

Outcome:

Modify Borg Dyspnea Score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疲乏量表-14

指标类型:

主要指标 

Outcome:

Fatigue scale-14

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易抑郁自评量表

指标类型:

主要指标 

Outcome:

Patient Health Questionnaire

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床呼吸症状量表

指标类型:

主要指标 

Outcome:

Clinical Respiratory Symptom Scale

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:

Biood

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 0 years
最大 Max age 100 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):

统计人员应用随机数生成器(IBM Corp.,Armonk,NY,美国)自动生成的随机序列号,并将其交给一个第三方研究人员。该人员将随机号依次放在不透明的信封中对其进行顺序编号,完成后将这些信封交给研究协调员。 研究协调人员将依次打开随机分配信封,并联系受试者相应的分配参与者。

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

The statistician applies a random sequence number automatically generated by a random number generator (IBM Corp., Armonk, NY, United States) and hands it to a third-party researcher. The person placed the random numbers in opaque envelopes and numbered them sequentially, and after completion, handed over these env

盲法:

受试者和六字诀训练师因为是物理治疗所以无法采用盲法,但训练师将不知道评估结果的内容。 为了降低产生偏差的风险,评估人员,数据管理人员和统计学家不了解结果评估过程和数据分析中的小组分配。

Blinding:

Participants and Liu-zi-jue trainers are unable to be blind about group assignments due to the specific intervention, but the trainers will not know the assessment of outcomes. To reduce the risk of bias, evaluators, data managers, and statisticians were unaware of group assignments in the outcome evaluation process and data analysis.

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

将在权威公共平台公布原始数据网址是ResMan

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

The original data URL to be published on the authoritative public platform is ResMan

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:

在招募阶段,筛选人员将收集参与者的人口统计信息。 数据评估员将通过CRF记录患者的基线特征和结果。 接下来,两名经过严格数据管理培训的第三方人员将以excel数据库的形式接收数据,然后将实时数据输入中国临床试验注册中心。病例报告表(CRF)的填写与数据的录入:数据录入与管理在该平台进行,网络平台: ResMan Research Manager ; 网址:http://www.medresman.org/login.aspx。该系统集成了电子病例报告表(eCRF)构建、数据录入、数据锁定及导出,能够科学的对试验数据进行跟踪管理和实时监控。

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

During the recruitment phase, screeners will collect demographics of the participants. The data assessor will record the baseline characteristics of the patient and the outcomes through a CRFs. Next, two third-party personnel who have received strict data management training will receive data in the form of an excel database, and then they will enter the real-time data into the China Clinical Trial Registration Center.Filling in the case report form (CRF) and data entry: data entry and management are carried out on this platform, web platform: ResMan Research Manager; website http://www.medresman.org/login.aspx. The system integrates electronic case report form (eCRF) construction, data entry, data locking and export, which can scientifically track and manage test data and real-time monitoring

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-27
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