A Medical Records Based Study on Wenyang Huoxue Decoction in Treating Bradyarrhythmia

注册号:

Registration number:

ITMCTR2000003928

最近更新日期:

Date of Last Refreshed on:

2020-08-23

注册时间:

Date of Registration:

2020-08-23

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

温阳活血汤治疗缓慢性心律失常:基于病历记录的研究

Public title:

A Medical Records Based Study on Wenyang Huoxue Decoction in Treating Bradyarrhythmia

注册题目简写:

English Acronym:

研究课题的正式科学名称:

温阳活血汤治疗缓慢性心律失常

Scientific title:

A Medical Records Based Study on Wenyang Huoxue Decoction in Treating Bradyarrhythmia

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2000036444 ; ChiMCTR2000003928

申请注册联系人:

张菀桐

研究负责人:

翁维良

Applicant:

ZHANG Wan-tong

Study leader:

WENG Wei-liang

申请注册联系人电话:

Applicant telephone:

+86 13311176716

研究负责人电话:

Study leader's telephone:

+86 13001927671

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:

wantong_zhang@hotmail.com

研究负责人电子邮件:

Study leader's E-mail:

ww6488@126.com

申请单位网址(自愿提供):

Study leader's 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:

北京市海淀区西苑操场1号西苑医院

研究负责人通讯地址:

北京市海淀区西苑操场1号西苑医院

Applicant address:

1 Xiyuan Playground, Haidian District, Beijing, China

Study leader's address:

1 Xiyuan Playground, Haidian District, Beijing, China

申请注册联系人邮政编码:

Applicant postcode:

100091

研究负责人邮政编码:

Study leader's postcode:

100091

申请人所在单位:

中国中医科学院西苑医院

Applicant's institution:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2018XLA035-2

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2018/5/23 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

ZI Ming-jie

伦理委员会联系地址:

北京市海淀区西苑操场1号西苑医院

Contact Address of the ethic committee:

Xiyuan Hospital, 1 Xiyuan Playground, Haidian 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:

中国中医科学院西苑医院

Primary sponsor:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号西苑医院

Primary sponsor's address:

1 Xiyuan Playground, Haidian 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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

具体地址:

北京市海淀区西苑操场1号西苑医院

Institution
hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Address:

1 Xiyuan Playground, Haidian District, Beijing

经费或物资来源:

北京中医药薪火传承3+3工程项目——翁维良名医工作室

Source(s) of funding:

Beijing TRADITIONAL Chinese medicine fire inheritance 3+3 project - Weng Weiliang nominal studio

研究疾病:

缓慢性心律失常

研究疾病代码:

Target disease:

bradycardia

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

单臂

Single arm

研究所处阶段:

Study phase:

回顾性研究

Retrospective study

研究目的:

探讨温阳活血汤治疗缓慢性心律失常的临床疗效,为缓慢性心律失常患者制定新的治疗方案。

Objectives of Study:

To explore the clinical effect of Wenyang Huoxue Decoction on the treatment of bradyarrhythmia, and to formulate a new treatment plan for patients with bradyarrhythmia.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1 符合病态窦房结综合征或房室传导阻滞诊断标准的患者病例; 2 患者初始服药前信息至少包括: (1)人口学资料; (2)就诊前一月内24小时动态心电图检查结果; 3 接受翁维良温阳活血法治疗2周及以上者; 4 至少有治疗后一次24小时动态心电图检查结果。

Inclusion criteria

1. Cases of patients who meet the diagnostic criteria of sick sinus syndrome or atrioventricular block; 2. The patient's initial pre-medication information includes at least: (1) demographic data; (2) the results of a 24-hour ambulatory electrocardiogram within one month before the visit; 3. Those who have been treated by Professor Weng Weiliang applying the method of Warming Yang and promoting blood circulation for 2 weeks or more; 4. At least one 24-hour ambulatory electrocardiogram result after treatment.

排除标准:

病例资料不完整。

Exclusion criteria:

The case information is incomplete.

研究实施时间:

Study execute time:

From 2018-08-01

To      2018-12-31

征募观察对象时间:

Recruiting time:

From 2019-08-01

To      2020-12-31

干预措施:

Interventions:

组别:

Case series

样本量:

300

Group:

Case series

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

None

Intervention code:

样本总量 Total sample size : 300

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

单位级别:

三级甲等

Institution/hospital:

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

心电图

指标类型:

次要指标

Outcome:

ECG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

24小时动态心电图

指标类型:

主要指标

Outcome:

Holter

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:

组织:

Sample Name:

None

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:

结束

Completed

年龄范围:

最小
Min age years
最大
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

非随机

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

Non-randomized

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing:

Yes

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):

采用向机构伦理委员会索要的方法,在相关论文发表过程中或发表后索要原始数据

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

Request the original data to the Institutional Ethics Committee during the publication or publication of the relevant articles

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:

应用病例记录表采集和管理数据

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

Using case record table for data collection and management

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above