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调整生活方式对耳聋、耳鸣、眩晕等耳鼻喉科常见疑难疾病的疗效研究
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注册号:

Registration number:

ChiCTR-INR-17011459 

最近更新日期:

Date of Last Refreshed on:

2017-05-25 

注册时间:

Date of Registration:

2017-05-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

调整生活方式对耳聋、耳鸣、眩晕等耳鼻喉科常见疑难疾病的疗效研究 

Public title:

A series of researches on effect of life-style modification method for complicated ascites diseases such as hearing loss, tinnitus, and dizziness and so on 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

调整生活方式对耳聋、耳鸣、眩晕等耳鼻喉科常见疑难疾病的疗效研究 

Scientific title:

A series of researches on effect of life-style modification method for complicated ascites diseases such as hearing loss, tinnitus, and dizziness and so on 

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:

钟娟 

研究负责人:

郑芸 

Applicant:

Zhong Juan 

Study leader:

Zheng Yun 

申请注册联系人电话:

Applicant telephone:

+86 18280200540 

研究负责人电话:

Study leader's telephone:

+86 18980601844 

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:

zhjiacinv@163.com 

研究负责人电子邮件:

Study leader's E-mail:

18980601844@189.cn 

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:

四川成都国学巷37号 

研究负责人通讯地址:

四川成都国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxuexiang, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital of Sichuan University 

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:

180 

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:

四川大学华西医院生物医学伦理分委会 

Name of the ethic committee:

Biomedical Branch of Ethics Committee of West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-07-19 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital of Sichuan University 

研究实施负责(组长)单位地址:

四川成都国学巷37号 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

sichuan

City:

chengdu

单位(医院):

四川大学华西医院

具体地址:

国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxuexiang, Chengdu, Sichuan, China

经费或物资来源:

本课题不涉及到实验室检查、试剂等费用,打印复印费等自筹 

Source(s) of funding:

self-financing 

研究疾病:

耳鸣;耳聋;眩晕 

Target disease:

Tinnitus; Hearing loss; dizziness 

研究疾病代码:

H93.101;BNS192;R42.X01 

Target disease code:

H93.101;BNS192;R42.X01 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过对常规推荐方式治疗无效或效果不佳的耳聋、耳鸣、眩晕等耳鼻喉科常见疑难疾病患者进行该治疗方式以观察其临床疗效及影响疗效的各种影响因素,并提出该类疾病的治疗规范。 

Objectives of Study:

To know and learn the efficacy and efficacy influence factors of life-style modification method for complicated ascites diseases such as hearing loss, tinnitus, and dizziness and so on.To promot a treatment norm of those dieases. 

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) 在我院耳鼻咽喉科门诊就诊的患者,根据不同的纳入原则选择实验和对照研究对象。 2) 实验研究对象纳入原则 a) 急、慢性耳鼻喉科常见疑难疾病患者。 b) 诊断、病程符合实验的纳入条件并自愿加入实验,签署知情同意书的患者。 c) 尽量保证实验与对照组的分组均衡性。 3) 对照组对象纳入原则 a) 对符合纳入标准的患者依据随机分配原则进入对照组。 

Inclusion criteria

1. Tinnitus patients visit at specialist clinic in West China Hospital of Sichuan University. 2. Inclusion criteria of experimental group: (1) Cute or chronic commonly or stubborn diseases of otorhinolaryngology department. (2) Patients with clear diagnose and signed the consent form, willing to join in the group. (3) Grouping participants balance would be guaranteed in the experiment and control group. 3. Inclusion criteria of control group: (1) Patients according to the role of randomized control allocation to this group. 

排除标准:

不符合纳入标准的病例。 

Exclusion criteria:

Participants does not meet inclusion criteria. 

研究实施时间:

Study execute time:

From2016-07-01To 2019-07-01 

干预措施:

Interventions:

组别:

试验组

样本量:

75

Group:

experimental group

Sample size:

干预措施:

调整生活方式

干预措施代码:

Intervention:

Life-style modification

Intervention code:

组别:

对照组

样本量:

75

Group:

control group

Sample size:

干预措施:

空白对照

干预措施代码:

Intervention:

No intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

耳鸣

指标类型:

主要指标 

Outcome:

Improvement of tinnitus

Type:

Primary indicator 

测量时间点:

测量方法:

ITS量表和THI量表评估

Measure time point of outcome:

Measure method:

ITS, THI

指标中文名:

耳聋

指标类型:

主要指标 

Outcome:

Improvement of deaf

Type:

Primary indicator 

测量时间点:

测量方法:

听力学检查评估

Measure time point of outcome:

Measure method:

hearing test

指标中文名:

眩晕

指标类型:

主要指标 

Outcome:

Clearance of dizziness

Type:

Primary indicator 

测量时间点:

测量方法:

主观症状

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

不采集人体标本

组织:

Sample Name:

No

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 不限 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):

随机数字表

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

random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

ResMan平台

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

ResMan platform

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:

原始记录和病历记录表等都在ResMan中上传管理

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

ResMan platform is the sole platform to manage all raw data or case report files

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-05-22
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