Today is 2020-11-27

Study on Traditional Chinese Medicine Intervention Program for the Sequela of novel coronavirus pneumonia (COVID-19)
download

注册号:

Registration number:

ChiCTR2000038740 

最近更新日期:

Date of Last Refreshed on:

2020-09-30 

注册时间:

Date of Registration:

2020-09-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)后遗症中医药干预方案研究 

Public title:

Study on Traditional Chinese Medicine Intervention Program for the Sequela of novel coronavirus pneumonia (COVID-19) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于“新型冠状病毒肺炎病例登记系统”的新冠肺炎恢复期与后遗症中医药干预方案研究 

Scientific title:

Study on traditional Chinese Medicine intervention Program of COVID-19 's convalescence and sequelae based on COVID-19 case Registration system 

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:

张山 

研究负责人:

王成祥 

Applicant:

Shan Zhang 

Study leader:

Chengxiang Wang 

申请注册联系人电话:

Applicant telephone:

+86 17801222680 

研究负责人电话:

Study leader's telephone:

+86 18612922358 

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:

313012270@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wang601@vip.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:

北京市朝阳区安定门外小关街51号 

研究负责人通讯地址:

北京市朝阳区安定门外小关街51号 

Applicant address:

51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China 

Study leader's address:

51 Xiaoguan Street, Andingmenwai, 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:

BZYSY-2020KYKTPJ-06 

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:

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

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-04 

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北里43号渔阳大厦A610 

Contact Address of the ethic committee:

A610, Yuyang Building, 43 Xiaoguan Lane North, Anwai, Chaoyang District, Beijing, 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:

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 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 Xiaoguan Street, Chaoyang District

经费或物资来源:

北京中医药大学2020年度基本科研业务费项目 

Source(s) of funding:

Beijing University of Traditional Chinese Medicine 2020 Basic Scientific Research Business Expense Project 

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:

评价中医药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 effectiveness and safety of traditional Chinese medicine intervention in the treatment of patients with new coronary pneumonia during 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.符合新冠病毒肺炎恢复期患者 2.辨证属气阴两虚型; 3.对本研究知情同意,自愿参加临床研究; 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. Patients who meet the recovery period of new coronavirus pneumonia; 2. Syndrome differentiation is of Qi and Yin deficiency type; 3. Informed consent to this study, voluntarily participate in clinical research; 4. Can provide detailed contact information, have no short-term relocation wishes, and are willing to cooperate with follow-up. 

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;恶性肿瘤及有精神、神经障碍不能合作者; 3.过敏体质或对研究药物成分过敏者; 4.肝功能异常者、肾功能异常者。 

Exclusion criteria:

1. Patients with fasting water due to gastrointestinal bleeding, intestinal obstruction, etc.; 2. Those who cannot cooperate with the original severe brain, heart, liver, kidney and hematopoietic system diseases; those with malignant tumors and mental and neurological disorders who cannot cooperate; 3. People with allergies or allergic to the components of the research drug; 4. People with abnormal liver function and abnormal kidney function. 

研究实施时间:

Study execute time:

From2020-08-01To 2021-08-01 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2021-07-01 

干预措施:

Interventions:

组别:

桔杏君子颗粒组

样本量:

100

Group:

Jiexingjunzi granule 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:

芪贝扶正颗粒组

样本量:

100

Group:

Qibei Fuzheng granule formation

Sample size:

干预措施:

芪贝扶正颗粒

干预措施代码:

Intervention:

Qibei Fuzheng granule

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):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

湖北六七二中西医结合骨科医院 

单位级别:

三级医院 

Institution
hospital:

Hubei 672 Orthopaedics Hospital of Integrated Chinese and Western Medicine  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

中医证候评分

指标类型:

主要指标 

Outcome:

TCM syndrome score

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:

Curative effect index of TCM syndrome

指标中文名:

世界卫生组织生存质量测定量表简表

指标类型:

次要指标 

Outcome:

Summary of the World Health Organization quality of Life scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主症与体征积分

指标类型:

次要指标 

Outcome:

Score of main symptoms and signs

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:

Pulmonary 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:

心电图

指标类型:

副作用指标 

Outcome:

ECG

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

副作用指标 

Outcome:

Blood routine

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标 

Outcome:

urine routine

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

便常规

指标类型:

副作用指标 

Outcome:

stool routine

Type:

Adverse events 

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:

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):

本试验采用spss22.0统计软件编制病例随机分配表,临床研究者将合格观察病例按随机分配表随机分配至桔杏君子颗粒组或芪贝扶正颗粒组。

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

In this experiment, the random distribution table of cases was compiled by spss22.0 statistical software. according to the random distribution table, clinical researchers randomly assigned the qualified cases to orange Xingjunzi granule group or Qibei Fuzheng granule group.

盲法:

未说明

Blinding:

Not stated

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:

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):

2022.2.01,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):

2022.2.01,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:

 2020-09-30
return list