今天是:2019-12-12 星期四

The effect of metformin on PSA level
下载XML文档

注册号:

Registration number:

ChiCTR-PNRC-14004461 

最近更新日期:

Date of Last Refreshed on:

2016-08-28 

注册时间:

Date of Registration:

2014-04-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

The effect of metformin on PSA level 

Public title:

The effect of metformin on PSA level 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

The effect of metformin on PSA level 

Scientific title:

The effect of metformin on PSA level 

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:

Aslan Demir 

研究负责人:

Aslan Demir 

Applicant:

Aslan Demir 

Study leader:

Aslan Demir 

申请注册联系人电话:

Applicant telephone:

+90 5324658225 

研究负责人电话:

Study leader's telephone:

+90 5324658225 

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:

draslandemir@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

draslandemir@yahoo.com 

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:

Kafkas üniversitesi T?p Fakültesi Hastanesi üroloji ABD Kars-Turkiye 

研究负责人通讯地址:

Kafkas üniversitesi T?p Fakültesi Hastanesi üroloji ABD Kars-Turkiye 

Applicant address:

Kafkas üniversitesi Tip Fakültesi Hastanesi üroloji ABD Kars-Turkiye 

Study leader's address:

Kafkas üniversitesi Tip Fakültesi Hastanesi üroloji ABD Kars-Turkiye 

申请注册联系人邮政编码:

Applicant postcode:

36000 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

Kafkas University Faculty of Medicine 

Applicant's institution:

Kafkas University Faculty of Medicine 

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:

80576354-050-99/86 

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:

TC Kafkas üniversitesi T?p Fakültesi Dekanl??? Etik Kurul Bakanl 

Name of the ethic committee:

TC Kafkas üniversitesi T?p Fakültesi Dekanl??? Etik Kurul Bakanl 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-11-13 

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:

Kafkas University Faculty of Medicine 

Primary sponsor:

Kafkas University Faculty of Medicine 

研究实施负责(组长)单位地址:

NA 

Primary sponsor's address:

NA 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

Turkey

省(直辖市):

Merkez

市(区县):

Kars

Country:

Turkey

Province:

Merkez

City:

Kars

单位(医院):

Kafkas University Faculty of Medicine

具体地址:

Kafkas University Faculty of Medicine

Institution
hospital:

Kafkas University Faculty of Medicine

Address:

Kafkas University Faculty of Medicine

经费或物资来源:

NA 

Source(s) of funding:

NA 

研究疾病:

Prostatic diseases 

Target disease:

Prostatic diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

预防性研究 

Study type:

Prevention 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

To investigate whether oral metformin use will diminish PSA levels of the patients. 

Objectives of Study:

To investigate whether oral metformin use will diminish PSA levels of the patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

Aged 40-80 years old; Patients with Type 2 Diabetes Mellitus and taking oral metformin and other antidiabetic agents. 

Inclusion criteria

Aged 40-80 years old; Patients with Type 2 Diabetes Mellitus and taking oral metformin and other antidiabetic agents 

排除标准:

Age<40 years old 

Exclusion criteria:

Age<40 years old 

研究实施时间:

Study execute time:

From2014-04-02To  

干预措施:

Interventions:

组别:

3

样本量:

50

Group:

3

Sample size:

干预措施:

Blood sample for PSA levels

干预措施代码:

Intervention:

Blood sample for PSA levels

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

Turkey 

省(直辖市):

Merkez 

市(区县):

Kars 

Country:

Turkey 

Province:

Merkez 

City:

Kars 

单位(医院):

Kafkas University Faculty of Medicine 

单位级别:

Kafkas University Faculty of Medicine 

Institution
hospital:

Kafkas University Faculty of Medicine  

Level of the institution:

Kafkas University Faculty of Medicine 

测量指标:

Outcomes:

指标中文名:

Decreas in PSA levels

指标类型:

主要指标 

Outcome:

Decreas in PSA level

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:

Blood

组织:

Sample Name:

Blood

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:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age 80 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):

None randomised

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

None randomised

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-04-02
返回列表