成人穴位導電度與總膽固醇、三酸甘油脂濃度 之相關性

注册号:

Registration number:

ChiCTR-DDT-13003393 

最近更新日期:

Date of Last Refreshed on:

2016-02-19 14:09:44 

注册时间:

Date of Registration:

2013-03-27 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

成人穴位導電度與總膽固醇、三酸甘油脂濃度 之相關性

Public title:

Relationships between Meridian Conductance and Total Cholesterol/Triglyceride Concentration in Adults

注册题目简写:

English Acronym:

研究课题的正式科学名称:

成人穴位導電度與總膽固醇、三酸甘油脂濃度 之相關性

Scientific title:

Relationships between Meridian Conductance and Total Cholesterol/Triglyceride Concentration in Adults

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:

林群智 

研究负责人:

楊士樑 

Applicant:

Chun-Chih Lin 

Study leader:

Shih-Liang, Yang 

申请注册联系人电话:

Applicant telephone:

+886 972019645

研究负责人电话:

Study leader's
telephone:

+886 911125514

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:

benjasado@gmail.com

研究负责人电子邮件:

Study leader's E-mail:

ysl451ysl@yahoo.com.tw

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:

台灣省嘉義縣大林鎮南華路55號

研究负责人通讯地址:

台中市三民路一段199號

Applicant address:

55 Nanhua Road, Dalin, Chiayi County, Taiwan

Study leader's address:

199 Sec.1, San-Min Rd., Taichung City, Taiwan, R.O.C.

申请注册联系人邮政编码:

Applicant postcode:

62249

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

南華大學自然生物科技系/自然醫學所/通識教學中心

Applicant's institution:

Department of Natural Biotechnology/Graduate Institute of Natural Healing Sciences/General Education Center, Nanhua University, R.O.C.

研究负责人所在单位:

Affiliation of the Leader:

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

IRB-05-06

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

行政院衛生署台中醫院人體試驗委員會

Name of the ethic committee:

Institutional Review Board of Taichung Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2008-10-31 00:00:00

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:

行政院衛生署台中醫院

Primary sponsor:

Taichung Hospital, Department of Health, Executive Yuan, Taiwan

研究实施负责(组长)单位地址:

台灣省台中市三民路一段199號

Primary sponsor's address:

199 Sec. 1,San-Min Road, Taichung, Taiwan

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

行政院衛生署台中醫院

Source(s) of funding:

Taichung Hospital, Department of Health, Executive Yuan, R.O.C. (Taiwan)

研究疾病:

高脂血症  

Target disease:

Hyperlipidemia

研究疾病代码:

Target disease code:

研究类型:

诊断试验

Study type:

Diagnostic test

研究所处阶段:

I期临床试验 

Study phase:

1

研究设计:

诊断性病例对照试验 

Study design:

Diagnostic test: case-control 

研究目的:

本研究在探討經絡能量分析儀所檢測的穴位導電度與總膽固醇及三酸甘油脂生化檢驗數據結果的相關性。  

Objectives of Study:

Explore the relationship between the meridian conductance and Total Cholesterol/Triglycerol Levels in adults.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

排除有放置心律調節器及懷孕婦女。

Exclusion criteria:

Those who with pacemaker or pregnant women are excluded.

研究实施时间:

Study execute time:

From 2008-09-11 00:00:00 To 2009-05-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2008-09-11 00:00:00 To 2009-05-01 00:00:00

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

Index test:

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

例数:

Sample size:

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國

省(直辖市):

台灣 

市(区县):

 

Country:

China

Province:

Taiwan

City:

单位(医院):

行政院衛生署台中醫院 

单位级别:

行政院衛生署台中醫院 

Institution
hospital:

Taichung Hospital, Department of Health, Executive Yuan, Taiwan

Level of the institution:

Taichung Hospital, Department of Health, Executive Yuan, Taiwan

测量指标:

Outcomes:

指标中文名:

總膽固醇濃度

指标类型:

主要指标

Outcome:

total cholesterol Concentration

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

三酸甘油脂濃度

指标类型:

主要指标

Outcome:

triglyceride Concentration

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

穴位導電度

指标类型:

主要指标

Outcome:

Meridian Conductance

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:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 99 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):

NA

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

NA

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

NA

Blinding:

NA

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

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

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:

南華大學

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

Nanhua Univiersity

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2013-07-31 00:00:00