中医药治疗老年眩晕(后循环缺血)多中心、 队列研究

注册号:

Registration number:

ITMCTR2024000010

最近更新日期:

Date of Last Refreshed on:

2024-01-20

注册时间:

Date of Registration:

2024-01-20

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

中医药治疗老年眩晕(后循环缺血)多中心、 队列研究

Public title:

Multicenter, cohort study of traditional Chinese medicine in the treatment of vertigo (posterior circulation ischemia) in the elderly

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中医药治疗老年眩晕(后循环缺血)多中心、 队列研究

Scientific title:

Multicenter, cohort study of traditional Chinese medicine in the treatment of vertigo (posterior circulation ischemia) in the elderly

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:

申请注册联系人:

潘定举

研究负责人:

郭蕾

Applicant:

Pan Dingju

Study leader:

Guo Lei

申请注册联系人电话:

Applicant telephone:

13985413654

研究负责人电话:

Study leader's telephone:

18008510678

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:

792371581@qq.com

研究负责人电子邮件:

Study leader's E-mail:

guolei@gzy.edu.cn

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:

贵州省贵阳市云岩区宝山北路71号

研究负责人通讯地址:

贵州省贵阳市云岩区宝山北路71号

Applicant address:

No. 71, Baoshan North Road, Yunyan District, Guiyang City, Guizhou Province

Study leader's address:

No. 71, Baoshan North Road, Yunyan District, Guiyang City, Guizhou Province

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:

贵州中医药大学第一附属医院

Applicant's institution:

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

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:

2023009C

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

贵州中医药大学第一附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/1/9 0:00:00

伦理委员会联系人:

付鹏程

Contact Name of the ethic committee:

Fu Pengcheng

伦理委员会联系地址:

贵州省贵阳市云岩区宝山北路71号

Contact Address of the ethic committee:

No. 71, Baoshan North Road, Yunyan District, Guiyang City, Guizhou Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

18275615881

伦理委员会联系人邮箱:

Contact email of the ethic committee:

396569658@qq.com

研究实施负责(组长)单位:

贵州中医药大学第一附属医院

Primary sponsor:

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

贵州省贵阳市云岩区宝山北路71号

Primary sponsor's address:

No. 71, Baoshan North Road, Yunyan District, Guiyang City, Guizhou Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

贵州省

市(区县):

贵阳市

Country:

China

Province:

Guizhou Province

City:

Guiyang City

单位(医院):

贵州省中医药管理局

具体地址:

贵州省贵阳市云岩区中华北路224号

Institution
hospital:

Guizhou Provincial Administration of Traditional Chinese Medicine

Address:

No. 224, Zhonghua North Road, Yunyan District, Guiyang City, Guizhou Province

经费或物资来源:

贵州省财政厅

Source(s) of funding:

Guizhou Provincial Department of Finance

研究疾病:

后循环缺血

研究疾病代码:

Target disease:

Posterior Circulation Ischemia

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

其它

Others

研究目的:

采用前瞻性队列研究设计方法,评价中医药治疗老年眩晕(后循环缺血)的临床疗效及安全性。

Objectives of Study:

A prospective cohort study design method was used to evaluate the clinical efficacy and safety of traditional Chinese medicine in the treatment of vertigo (posterior circulation ischemia) in the elderly.

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年龄≥60岁; ②符合后循环缺血西医诊断标准; ③符合中医眩晕诊断标准,病程在发作后期及恢复期患者; ④符合中医证候诊断标准者; ⑤同意参与研究,并签署知情同意书病人。

Inclusion criteria

①Age ≥60 years old; ②Meet the diagnostic criteria of Western medicine for posterior circulation ischemia; ③Meet the diagnostic criteria of traditional Chinese medicine for vertigo, and the disease course is in the late onset and recovery period; ④Those who meet the diagnostic criteria of traditional Chinese medicine syndrome; ⑤Agree to participate in the study and sign informed consent Book patient.

排除标准:

①严重的脑血管疾病所致完全瘫痪患者; ②脑部肿瘤、脑外伤、血液病、脑梗死(急性期及恢复期)、脑出血等引起的眩晕。 ③研究中心首次门诊\急诊\住院治疗中,采用针灸、中成药治疗的患者; ④失能失智,长期卧床患者; ⑤不愿配合随访者。

Exclusion criteria:

① Patients with complete paralysis caused by severe cerebrovascular disease; ② Dizziness caused by brain tumors, brain trauma, blood diseases, cerebral infarction (acute phase and recovery phase), cerebral hemorrhage, etc. ③Patients treated with acupuncture and Chinese patent medicines during the first outpatient, emergency, and inpatient treatment at the research center; ④Patients with disability, dementia, and long-term bedridden; ⑤Those who are unwilling to cooperate with follow-up.

研究实施时间:

Study execute time:

From 2023-12-01

To      2024-12-31

征募观察对象时间:

Recruiting time:

From 2024-01-31

To      2024-08-31

干预措施:

Interventions:

组别:

暴露组

样本量:

500

Group:

Exposome group

Sample size:

干预措施:

采用中药处方治疗

干预措施代码:

Intervention:

Treatment with traditional Chinese medicine prescriptions

Intervention code:

组别:

对照组

样本量:

500

Group:

Control group

Sample size:

干预措施:

单纯西医治疗

干预措施代码:

Intervention:

Simple Western medicine treatment

Intervention code:

样本总量 Total sample size : 1000

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

贵州省

市(区县):

遵义市

Country:

China

Province:

Guizhou Province

City:

Zunyi City

单位(医院):

遵义市中医院

单位级别:

三级甲等中医医院

Institution/hospital:

Zunyi Traditional Chinese Medicine Hospital

Level of the institution:

Grade 3A traditional Chinese medicine hospital

国家:

中国

省(直辖市):

贵州省

市(区县):

贵阳市

Country:

China

Province:

Guizhou Province

City:

Guiyang City

单位(医院):

贵州医科大学附属医院

单位级别:

三级甲等医院

Institution/hospital:

Affiliated Hospital of Guizhou Medical University

Level of the institution:

Class 3A hospital

国家:

中国

省(直辖市):

贵州省

市(区县):

贵阳市

Country:

China

Province:

Guizhou Province

City:

Guiyang City

单位(医院):

贵航贵阳医院

单位级别:

三级甲等医院

Institution/hospital:

Guihang Guiyang Hospital

Level of the institution:

Class 3A hospital

国家:

中国

省(直辖市):

贵州省

市(区县):

贵阳市

Country:

China

Province:

Guizhou Province

City:

Guiyang City

单位(医院):

贵州中医药大学第二附属医院

单位级别:

三级甲等中医医院

Institution/hospital:

The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Level of the institution:

Grade 3A traditional Chinese medicine hospital

国家:

中国

省(直辖市):

贵州省

市(区县):

贵阳市

Country:

China

Province:

Guizhou Province

City:

Guiyang City

单位(医院):

贵州中医药大学第一附属医院

单位级别:

三级甲等中医医院

Institution/hospital:

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Level of the institution:

Grade 3A traditional Chinese medicine hospital

测量指标:

Outcomes:

指标中文名:

门\急诊、住院治疗12天内眩晕消失率

指标类型:

主要指标

Outcome:

Vertigo disappearance rate within 12 days of outpatient, emergency and hospitalization treatment

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院后眩晕最近一次复发时间

指标类型:

次要指标

Outcome:

Time of latest recurrence of vertigo after discharge from hospital

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院后6个月内眩晕急诊/住院率

指标类型:

次要指标

Outcome:

Vertigo emergency room/hospitalization rate within 6 months after discharge

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院后6个月内眩晕复发的次数

指标类型:

次要指标

Outcome:

Number of recurrences of vertigo within 6 months after discharge

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:

组织:

Sample Name:

none

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 60
Min age years
最大 90
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):

为观察性研究,不进行随机

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

This is an observational study, not randomized

盲法:

Blinding:

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):

https://www.zydyfy.cn/additions/ctms/ 贵州中医药大学第一附属医院中医循证能力管理平台

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

https://www.zydyfy.cn/additions/ctms/

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:

https://www.zydyfy.cn/additions/ctms/ 贵州中医药大学第一附属医院中医循证能力管理平台的临床数据采集和管理系统

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

No

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):

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