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阿维A联合甲氨蝶呤治疗中重度寻常型银屑病
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注册号:

Registration number:

ChiCTR-INR-16009710 

最近更新日期:

Date of Last Refreshed on:

2017-08-19 

注册时间:

Date of Registration:

2016-11-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

阿维A联合甲氨蝶呤治疗中重度寻常型银屑病 

Public title:

Acitretin plus methotrexate in the treatment of moderate to severe psoriasis vulgaris 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

角蛋白17通过PI3K/Akt信号通路在银屑病发病机制中的作用研究 

Scientific title:

The role of keratin 17 in the pathogenesis of psoriasis through PI3K/Akt signal pathways 

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:

安金刚 

研究负责人:

夏育民 

Applicant:

An Jingang 

Study leader:

xia yumin 

申请注册联系人电话:

Applicant telephone:

+86 029 87679301 

研究负责人电话:

Study leader's telephone:

+86 029 87679527 

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:

anjg2008@126.com 

研究负责人电子邮件:

Study leader's E-mail:

xiayumin1202@163.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:

陕西省西安市西五路157号 

研究负责人通讯地址:

陕西省西安市西五路157号 

Applicant address:

157 Xi'wu Road, Xi'an, Shaanxi, China 

Study leader's address:

157 Xi'wu Road, Xi'an, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

710004 

研究负责人邮政编码:

Study leader's postcode:

710004 

申请人所在单位:

西安交通大学第二附属医院 

Applicant's institution:

the Second Affiliated Hospital, School of Medicine, Xi'an Jiaotong 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:

2015022 

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:

西安交通大学医学院第二附属医院医学伦理委员会 

Name of the ethic committee:

Medical science research ethics committee of the Second Affiliated Hospital, School of Medicine, Xi'an Jiaotong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-03-03 

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:

西安交通大学第二附属医院 

Primary sponsor:

the Second Affiliated Hospital, School of Medicine, Xi'an Jiaotong University 

研究实施负责(组长)单位地址:

陕西省西安市西五路157号 

Primary sponsor's address:

157 Xi'wu Road, Xi'an, Shaanxi, 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):

陕西省

市(区县):

西安市

Country:

China

Province:

Shaanxi

City:

xi'an

单位(医院):

西安交通大学第二附属医院

具体地址:

陕西省西安市西五路157号

Institution
hospital:

the Second Affiliated Hospital, School of Medicine, Xi'an Jiaotong University

Address:

157 Xi'wu Road, Xi'an, Shaanxi, China

经费或物资来源:

中国国家自然科学基金 

Source(s) of funding:

National natural science foundation of China 

研究疾病:

银屑病 

Target disease:

psoriasis 

研究疾病代码:

 

Target disease code:

 

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:

评价阿维A联合甲氨蝶呤治疗寻常型银屑病疗效和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of acitretin capsules plus methotrexate in the treatment of vulgaris psoriasis.  

药物成份或治疗方案详述:

阿维A胶囊;甲氨蝶呤片 

Description for medicine or protocol of treatment in detail:

acitretin capsules methotrexate tablet 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

(1)18~75周岁,性别不限; (2)确诊为寻常型银屑病,PASI评分>7且受累面积大于体表面积的10%; (3)自愿参加本试验,并签署知情同意书。  

Inclusion criteria

(1) Males and females aged between 18 and 75 years; (2) Mild psoriasis vulgaris defined by the following criteria: Body surface area (BSA)>10% at screening and baseline and PASI>7 at screening and baseline; (3) Provide written informed consent and Willing and able to comply with all aspects of the protocol.  

排除标准:

(1)红皮病型、关节型、脓疱型或点滴状银屑病患者; (2)有其他活动性皮肤疾病,可能影响病情评估者; (3)1个月内曾系统接受研究性药物、生物制剂及免疫抑制剂治疗; (4)2周内曾接受外用糖皮质激素、煤焦油、光疗等治疗; (5)处于严重的难以控制的局部或全身急、慢性感染期间; (6)有乙型或丙型肝炎病史;或HIV抗体阳性者; (7)谷丙转氨酶、谷草转氨酶或血脂大于正常值上限1.5倍者; (8)有严重系统性疾病或恶性肿瘤病史者; (9)孕妇、哺乳期妇女及2年内有生育计划者; (10)对甲氨蝶呤和阿维A过敏者; (11)研究者认为不宜参加试验的其他情况。  

Exclusion criteria:

1. Other types of psoriasis than mild psoriasis vulgaris eg, guttate, pustular, erythodermic, etc; 2. Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim; 3. Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit eg: drugs for other studys, immuno-suppressive drugs, biologics; 4. Patients who used topical treatment within 2 weeks before the Baseline visit eg corticosteroids ultraviolet-light therapy including sunbathing , or liquor carbonis detergens; 5. Active infectious disease which was hard to control; 6. History of hepatitis B or hepatitis C, and advanced HIV infection; 7. Laboratory data such as alanine aminotransferase (ALT), aspartate aminotransferase (AST) and blood lipid profile was 1.5 times higher than the normal limits; 8. History of severe systemic disease or cancer; 9. Pregnant or lactating females or willing to pregnant in 2 years; 10. patients who has allergy of methotrexate and Acitretin any ingredient; 11. Any other situations not suitable for this study determined by the investigators.  

研究实施时间:

Study execute time:

From2016-11-01To 2016-12-31 

干预措施:

Interventions:

组别:

阿维A组

样本量:

100

Group:

acitretin capsules group

Sample size:

干预措施:

阿维A胶囊每次1粒,每日2次。

干预措施代码:

Intervention:

Acitretin Capsules 1 pills, twice a day

Intervention code:

组别:

甲氨蝶呤组

样本量:

100

Group:

methotrexate

Sample size:

干预措施:

甲氨蝶呤第一周7.5mg,第二周开始每周25mg

干预措施代码:

Intervention:

methotrexate 7.5 mg/w, and then 25mg/W

Intervention code:

组别:

阿维A联合甲氨蝶呤治疗组

样本量:

100

Group:

Acitretin plus methotrexate group

Sample size:

干预措施:

阿维A胶囊每次1粒,每日2次。甲氨蝶呤第一周7.5mg,第二周开始每周25mg

干预措施代码:

Intervention:

Acitretin Capsules 1 pills, twice a day.methotrexate 7.5 mg/w, and then 25mg/W.

Intervention code:

组别:

空白对照组

样本量:

50

Group:

blank group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西省 

市(区县):

西安市 

Country:

China 

Province:

Shaanxi 

City:

xi'an 

单位(医院):

西安交通大学第二附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

the Second Affiliated Hospital, School of Medicine, Xi'an Jiaotong University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

银屑病皮损面积和严重程度指数

指标类型:

主要指标 

Outcome:

Psoriasis Area and Severity Index ( PASI)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

附加指标 

Outcome:

Blood-routine

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化检查

指标类型:

附加指标 

Outcome:

Blood biochemical examination

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子α

指标类型:

附加指标 

Outcome:

TNF-α

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤病生活质量指标

指标类型:

次要指标 

Outcome:

dermatology life quality index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝纤维化指标

指标类型:

附加指标 

Outcome:

cators of hepatic fibrosis

Type:

Additional 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:

血液

组织:

皮肤

Sample Name:

blood

Tissue:

skin 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

随机序列由实验研究者之外的人员用电脑生成

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

The allocation sequence is computer-generated with a varying block size kept unknown to the investigators.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

预计在实验结束后6个月即2017年8月31前,将原始数据上传至中国临床实验注册中心网站:http://www.chictr.org.cn/

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

It is expected that the original data will be uploaded to the China Clinical Laboratory Registry website 6 months after the end of the experiment, ie August 31, 2017. http://www.chictr.org.cn/

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:

SPSS数据库

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

SPSS database

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-11-02
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