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Study for efficacy and safety of Jie-Xing-Jun-Zi granules in the Treatment of convalescent patients of novel coronavious pneumonia (COVID-19)
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注册号:

Registration number:

ChiCTR2000032313 

最近更新日期:

Date of Last Refreshed on:

2020-04-26 

注册时间:

Date of Registration:

2020-04-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

桔杏君子颗粒干预新型冠状病毒肺炎(COVID-19)恢复期患者的疗效与安全性评价 

Public title:

Study for efficacy and safety of Jie-Xing-Jun-Zi granules in the Treatment of convalescent patients of novel coronavious pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

桔杏君子颗粒干预新型冠状病毒肺炎恢复期患者的疗效与安全性评价 

Scientific title:

Study for efficacy and safety of Jie-Xing-Jun-Zi granules in the Treatment of convalescent patients of novel coronavious 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:

ChiMCTR2000003243 

申请注册联系人:

秦欣欣 

研究负责人:

崔红生 

Applicant:

Xinxin Qin 

Study leader:

Hongsheng Cui 

申请注册联系人电话:

Applicant telephone:

+86 15600790166 

研究负责人电话:

Study leader's telephone:

+86 13901101359 

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:

qinxinxin1992@126.com 

研究负责人电子邮件:

Study leader's E-mail:

hshcui@sina.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:

北京市朝阳区安外小关街51号 

研究负责人通讯地址:

北京市朝阳区安外小关街51号 

Applicant address:

51 Anwai Xiaoguan Street, Chaoyang District, Beijing, China 

Study leader's address:

51 Anwai Xiaoguan Street, Chaoyang District, Beijing, 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:

北京中医药大学第三附属医院 

Applicant's institution:

Beijing University of Chinese Medicine, Third Affiliated Hospital 

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:

ECBJZYYKJFZZJSL-ZYDSY2020-01 

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:

北京中医药大学第三附属医院科研伦理委员会 

Name of the ethic committee:

Scientific Research Ethics Committee of Beijing University of Chinese Medicine Third Affiliated Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-01 

伦理委员会联系人:

赵莹 

Contact Name of the ethic committee:

Ying Zhao 

伦理委员会联系地址:

北京市朝阳区安外小关街51号 

Contact Address of the ethic committee:

51 Anwai Xiaoguan Street, Chaoyang District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010 84980751 

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:

北京中医药大学第三附属医院 

Primary sponsor:

Beijing University of Chinese Medicine Third Affiliated Hospital 

研究实施负责(组长)单位地址:

北京市朝阳区安外小关街51号 

Primary sponsor's address:

51 Anwai Xiaoguan Street, Chaoyang 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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学第三附属医院

具体地址:

北京市朝阳区安外小关街51号

Institution
hospital:

Beijing University of Chinese Medicine Third Affiliated Hospital

Address:

51 Anwai Xiaoguan Street, Chaoyang 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:

评价桔杏君子颗粒干预治疗新冠肺炎恢复期患者的有效性和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of Juxingjunzi Granules in the interventional treatment of patients with novel coronavious pneumonia in the recovery period. 

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)符合新冠状病毒肺炎恢复期患者,年龄在18-75岁; (2)符合气阴两伤,余邪未尽证候诊断标准; (3)自愿受试,或直系亲属或患者认可的委托人同意受试,并自愿签署知情同意书; (4)能提供详细联络方式,无短期迁移意愿,能够愿意配合随访者。 

Inclusion criteria

(1) Convalescent patients with novel coronavious pneumonia,and the patient is aged 18-75 years old; (2) The TCM syndrome type conforms to deficiency of 'qi' and 'yin' and not exhausted of 'Yu Xie'; (3) Voluntary test, or the immediate family or the client's approved client agrees to the test, and voluntarily signs the informed consent; (4) Provide detailed contact information, no short-term willingness to move and be willing to cooperate with followers. 

排除标准:

(1)因消化道出血、肠梗阻等禁食水的患者; (2)原有严重脑、心、肝、肾和造血系统等疾病不能配合者; (3)已知的对干预药物成分过敏者; (4)无法配合随访者。 

Exclusion criteria:

(1) Patients with fasting water due to gastrointestinal bleeding, intestinal obstruction, etc; (2) Patients with pre-existing severe brain, heart, liver, kidney and hematopoietic system diseases; (3) Patients who are known to be allergic to the ingredients of the intervention drug; (4) Patients who are unable to cooperate with follow-up. 

研究实施时间:

Study execute time:

From2020-05-01To 2020-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

桔杏君子颗粒

干预措施代码:

Intervention:

Jiexingjunzi granules

Intervention code:

组别:

对照组

样本量:

30

Group:

control group

Sample size:

干预措施:

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):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学第三附属医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing University of Chinese Medicine Third Affiliated Hospital  

Level of the institution:

Tertiary A Hospital  

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中日友好医院 

单位级别:

三甲医院 

Institution
hospital:

China-Japan Friendship Hospital  

Level of the institution:

Tertiary A Hospital  

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

东直门医院 

单位级别:

三甲医院 

Institution
hospital:

Berjing Dong zhi men Hospital  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

中医证候改善

指标类型:

主要指标 

Outcome:

TCM syndrome curative effect

Type:

Primary indicator 

测量时间点:

测量方法:

中医证候疗效指数

Measure time point of outcome:

Measure method:

TCM syndrome curative effect index

指标中文名:

生存质量

指标类型:

次要指标 

Outcome:

Quality of Life

Type:

Secondary indicator 

测量时间点:

测量方法:

世界卫生组织生存质量测定量表简表

Measure time point of outcome:

Measure method:

WHOQOL-BREF

指标中文名:

6 分钟步行距离

指标类型:

次要指标 

Outcome:

6MWD

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺功能

指标类型:

次要指标 

Outcome:

Lung function

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检查

指标类型:

次要指标 

Outcome:

Chest CT examination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒核酸复阳率

指标类型:

次要指标 

Outcome:

Reversion rate of viral nucleic acid

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:

呼吸道分泌物

组织:

Sample Name:

Respiratory secretions

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 75 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):

采用区组随机化将全部入选病例分到试验组和对照组,区组大小为6。应用SAS统计软件编制病例随机分配表将患者随机分为治疗组和对照组。

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

Using block randomization, all selected cases are divided into test group and control group, and the block size is 6. Using SAS statistical software to compile a random case allocation table to randomly divide patients into treatment and control groups.

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

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):

2021-06-30,向研究者索取

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

2021-06-30,From the researcher

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-25
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