眩晕病多学科临床医学研究中心开发应用

注册号:

Registration number:

ITMCTR2024000793

最近更新日期:

Date of Last Refreshed on:

2024-12-11

注册时间:

Date of Registration:

2024-12-11

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

眩晕病多学科临床医学研究中心开发应用

Public title:

Development and Application of Multidisciplinary Clinical Medical Research Center for Vertigo Disease

注册题目简写:

English Acronym:

研究课题的正式科学名称:

眩晕病多学科临床医学研究中心开发应用

Scientific title:

Development and Application of Multidisciplinary Clinical Medical Research Center for Vertigo Disease

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:

李国徽

研究负责人:

李国徽

Applicant:

Guohui Li

Study leader:

Guohui Li

申请注册联系人电话:

Applicant telephone:

+86 189 9500 6005

研究负责人电话:

Study leader's telephone:

+86 189 9500 6005

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:

klaide@126.com

研究负责人电子邮件:

Study leader's E-mail:

klaide@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:

宁夏回族自治区银川市金凤区燕然路1号(银川市中医医院)

研究负责人通讯地址:

宁夏回族自治区银川市金凤区燕然路1号(银川市中医医院)

Applicant address:

No. 1 Yanran Road, Jinfeng District, Yinchuan City, Ningxia Hui Autonomous Region (Yinchuan Hospital of Traditional Chinese Medicine)

Study leader's address:

No. 1 Yanran Road, Jinfeng District, Yinchuan City, Ningxia Hui Autonomous Region (Yinchuan Hospital of Traditional Chinese Medicine)

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:

银川市中医医院

Applicant's institution:

Yinchuan Traditional Chinese Medicine Hospital

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:

YZYLLSC-2021-016

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:

银川市中医医院中医药科研伦理审查委员会

Name of the ethic committee:

Yinchuan Traditional Chinese Medicine Hospital Traditional Chinese Medicine Research Ethics Review Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2021/8/2 0:00:00

伦理委员会联系人:

杨云

Contact Name of the ethic committee:

Yun Yang

伦理委员会联系地址:

宁夏回族自治区银川市金凤区燕然路1号(银川市中医医院)

Contact Address of the ethic committee:

No. 1 Yanran Road, Jinfeng District, Yinchuan City, Ningxia Hui Autonomous Region (Yinchuan Hospital of Traditional Chinese Medicine)

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 189 9500 6005

伦理委员会联系人邮箱:

Contact email of the ethic committee:

klaide@126.com

研究实施负责(组长)单位:

银川市中医医院

Primary sponsor:

Yinchuan Hospital of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

宁夏回族自治区银川市金凤区燕然路1号(银川市中医医院)

Primary sponsor's address:

No. 1 Yanran Road Jinfeng District Yinchuan City Ningxia Hui Autonomous Region (Yinchuan Hospital of Traditional Chinese Medicine)

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

宁夏回族自治区

市(区县):

银川市

Country:

China

Province:

Ningxia

City:

YinChuan

单位(医院):

银川市中医医院

具体地址:

宁夏回族自治区银川市金凤区燕然路1号(银川市中医医院)

Institution
hospital:

Yinchuan Traditional Chinese Medicine Hospital

Address:

No. 1 Yanran Road Jinfeng District Yinchuan City Ningxia Hui Autonomous Region (Yinchuan Hospital of Traditional Chinese Medicine)

经费或物资来源:

银川市科技创新重大重点专项

Source(s) of funding:

Major Key Special Project for Science and Technology Innovation in Yinchuan City

研究疾病:

晕动病

研究疾病代码:

Target disease:

motion sickness

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

1.分析各前庭功能检查技术与眩晕类疾病之间的关系;2.评价颅底针法对治疗眩晕类疾病的临床疗效,并制定眩晕病中医特色治疗技术;3.探索和总结梅尼埃病、良性阵发性位置性眩晕、前庭神经元炎诊疗方案,包括诊断、治疗、疗效评价、预防及应对等多方面内容;

Objectives of Study:

1. Analyze the relationship between various vestibular function examination techniques and vertigo related diseases; 2. Evaluate the clinical efficacy of skull base acupuncture in treating vertigo related diseases and develop traditional Chinese medicine characteristic treatment techniques for vertigo; 3. Explore and summarize the diagnosis and treatment plans for Meniere's disease benign paroxysmal positional vertigo and vestibular neuritis including diagnosis treatment efficacy evaluation prevention and response among other aspects; 4. Publish 2 domestic and foreign academic papers around the research content; 5. Introduce one master's student and cultivate one master's student.

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)符合中医诊断标准;(2)年龄18~65岁者;(3)近3个月未接受药物或针灸治疗者;(4)按时完整接受检查、治疗者;(5)自愿参加本研究并签署知情同意书者。

Inclusion criteria

(1) Meets the diagnostic criteria of traditional Chinese medicine; (2) 18-65 years old; (3) Those who have not received medication or acupuncture and moxibustion treatment in recent 3 months; (4) Those who undergo complete examination and treatment on time; (5) Those who voluntarily participate in this study and sign an informed consent form.

排除标准:

(1)妊娠或哺乳期;(2)年龄大于或等于65岁患者;(3)不能坚持完成治疗者;(4)其他类型的眩晕如恶性肿瘤、严重贫血、高血压、脑梗塞等。(5)合并心、肝、肾等重要脏器严重器质性疾病、恶性肿瘤患者、造血系统严重原发性疾病患者;(6)严重肝肾功不全者。(7)近2周服用相关药物及行针灸治疗,影响疗效判定者。

Exclusion criteria:

(1) Pregnancy or lactation period; (2) Patients aged 65 years or older; (3) Those who cannot persist in completing treatment; (4) Other types of dizziness such as malignant tumors severe anemia hypertension cerebral infarction etc. (5) Patients with severe organic diseases malignant tumors and severe primary diseases of the hematopoietic system associated with important organs such as the heart liver and kidneys; (6) Severe liver and kidney dysfunction. (7) Those who take relevant drugs and perform acupuncture and moxibustion treatment in the past 2 weeks and affect the efficacy judgment.

研究实施时间:

Study execute time:

From 2021-09-01

To      2024-09-30

征募观察对象时间:

Recruiting time:

From 2022-01-01

To      2024-01-01

干预措施:

Interventions:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

内热针刺

干预措施代码:

Intervention:

Internal heat needling

Intervention code:

组别:

试验组

样本量:

50

Group:

Experimental group

Sample size:

干预措施:

普通针刺

干预措施代码:

Intervention:

Ordinary acupuncture

Intervention code:

样本总量 Total sample size : 100

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

宁夏回族自治区

市(区县):

银川市

Country:

China

Province:

NingXia

City:

YinChuan

单位(医院):

银川市中医医院

单位级别:

三级甲等中医医院

Institution/hospital:

Yinchuan Hospital of Traditional Chinese Medicine

Level of the institution:

Grade III Grade A Traditional Chinese Medicine Hospital

测量指标:

Outcomes:

指标中文名:

耳鸣残障量表

指标类型:

次要指标

Outcome:

tinnitus handicap inventoryTHI

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

前庭功能检查

指标类型:

主要指标

Outcome:

vestibular function examination

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

耳闷视觉模拟量表

指标类型:

主要指标

Outcome:

visual analogue scalesVAS

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颞骨CT

指标类型:

主要指标

Outcome:

Temporal bone CT

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眩晕病临床证候评价量表

指标类型:

主要指标

Outcome:

Clinical Symptom Evaluation Scale for Vertigo

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眩晕残障量表

指标类型:

主要指标

Outcome:

dizziness handicap inventoryDHI

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:

非人体标本

组织:

颞骨CT、前庭功能检查

Sample Name:

Non-human specimen

Tissue:

Temporal bone CT and vestibular function examination

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

结束

Completed

年龄范围:

最小 18
Min age years
最大 65
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):

通过软件SPSS25.0产生随机数字表,对初筛合格者依次按照随机数字表进行分组治疗,每组各50例,直到完成总观察例数后结束试验。采取组间平行对照及组内前后对照方法。

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

Generate a random number table through software SPSS25.0 and group qualified individuals into groups for treatment according to the random number table. Each group has 50 cases until the total number of observed cases is completed and the trial ends. Adopting parallel control between groups and intra group pre and post control methods.

盲法:

Blinding:

none

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):

临床试验公共管理平台(http://www.medresman.org.cn)。临床试验结束后以论文方式共享原始数据;日期:2024-12-30。

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

Clinical trial public management platform( http://www.medresman.org.cn ). After the clinical trial is completed share the original data in the form of a paper; Date: December 30th 2024.

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:

病例记录表;临床试验公共管理平台;

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

Case record form; http://www.medresman.org.cn/login.aspx;

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):

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统