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The antipruritic effect of qingpeng ointment in the localized non-exudative eczema and the changes of cytokines before and after treatment.
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注册号:

Registration number:

ChiCTR1800016190 

最近更新日期:

Date of Last Refreshed on:

2018-05-17 

注册时间:

Date of Registration:

2018-05-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

青鹏软膏在局限性非渗出性湿疹中的止痒作用及治疗前后细胞因子改变情况的分析 

Public title:

The antipruritic effect of qingpeng ointment in the localized non-exudative eczema and the changes of cytokines before and after treatment. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

青鹏软膏在局限性非渗出性湿疹中的止痒作用及治疗前后细胞因子改变情况的分析 

Scientific title:

The antipruritic effect of qingpeng ointment in the localized non-exudative eczema and the changes of cytokines before and after treatment. 

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:

徐薇 

研究负责人:

徐薇 

Applicant:

XU WEI 

Study leader:

XU WEI 

申请注册联系人电话:

Applicant telephone:

+86 18611015100 

研究负责人电话:

Study leader's telephone:

+86 18611015100 

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:

2403649155@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

2403649155@qq.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:

中国 北京市西城区永安路95号 

研究负责人通讯地址:

中国 北京市西城区永安路95号 

Applicant address:

95 Yong'an Road, Xicheng District, Beijing, China 

Study leader's address:

95 Yong'an Road, Xicheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100050 

研究负责人邮政编码:

Study leader's postcode:

100050 

申请人所在单位:

首都医科大学附属北京友谊医院皮肤科 

Applicant's institution:

Department of Dermatology, Beijing Friendship Hospital, Capital Medical 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:

2017-P2-159-01 

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:

首都医科大学附属北京友谊医院医学伦理委员会  

Name of the ethic committee:

Medical Ethics Committee, Beijing Friendship Hospital, Capital Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

李悦 

Contact Name of the ethic committee:

LiYue 

伦理委员会联系地址:

首都医科大学附属北京友谊医院科研处 

Contact Address of the ethic committee:

95 Yong'an Road, Xicheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13661202501 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

13661202501@163.com 

研究实施负责(组长)单位:

首都医科大学附属北京友谊医院皮肤科 

Primary sponsor:

Department of Dermatology, Beijing Friendship Hospital, Capital Medical University  

研究实施负责(组长)单位地址:

北京市西城区永安路95号 

Primary sponsor's address:

95 Yong'an Road, Xicheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京友谊医院皮肤科

具体地址:

北京市西城区永安路95号

Institution
hospital:

Department of Dermatology, Beijing Friendship Hospital, Capital Medical University

Address:

95 Yong'an Road, Xicheng District, Beijing, China

经费或物资来源:

中国中西医结合学会皮肤性病专业委员会 

Source(s) of funding:

Dermatological Subcommittee of China Society of Integrated Traditional Chinese and Western Medicine  

研究疾病:

限局性湿疹 

Target disease:

localized eczema 

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:

上市后药物 

Study phase:

研究目的:

初步探讨青鹏软膏治疗湿疹、缓解瘙痒的作用机制 

Objectives of Study:

The mechanism of qingpeng ointment in treating eczema and alleviating itchiness is discussed. 

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:

年龄18-65岁,男女不限;诊断符合局限性非渗出性湿疹,体表面积1%-15%;病程不限;无明显诱因;已阅读了受试者须知,同意并签署书面知情同意书。 

Inclusion criteria

1. aged from 18-80 years male and female; 2. Clinically Diagnosed localized chronic eczema, Skin involvement for 1% to 15% of body surface areapatients; 3. The disease has no obvious cause; 4. Participant fully understands the content of the clinical trial, is willing to attend the research voluntary andsign the informed consent form.  

排除标准:

已知对试验及对照药物过敏者;严重肝肾疾病,血液系统疾病,自身免疫病,慢性严重感染,糖尿病,精神病、恶性肿瘤或其他可能影响正确评估疗效的严重疾病者;局部用皮质类固醇停药时间小于2周;系统用皮质类固醇及其它免疫抑制剂(雷公藤等)停药时间小于4周;面部及皮肤皱褶部位湿疹;皮损总面积超过体表面积的15%或低于1%;研究者认为不宜入选的其他原因。 

Exclusion criteria:

1. allergic to the study drugs; 2. with severe disease in the liver, kidney, and/or blood; with autoimmune diseases, chronic serious infection, diabetes, mental diseases, substance abuse, and/or alcoholic; with the malignant tumor or other serious diseases that may compromise the accuracy of efficacy evaluation for the study drug; 3. apply corticosteroids cream within 2 weeks; have taken systemic corticosteroids or other systemic immune inhibitors (e.g. Tripterygium wilfordii et al.) within 4 weeks; 4. rash on face, skin folds such as anus, vulva; 5. Skin lesions with a total area of more than 15% of the body surface area or less than 1%; 6. other reasons that researchers think that should not be selected.  

研究实施时间:

Study execute time:

From2018-05-17To 2018-06-30 

征募观察对象时间:

Recruiting time:

From2018-05-17To 2018-06-17 

干预措施:

Interventions:

组别:

青鹏膏组

样本量:

30

Group:

Qing peng cream group

Sample size:

干预措施:

外用青鹏膏于患处, 每日2 次。

干预措施代码:

Intervention:

apply Qing peng cream, bid

Intervention code:

组别:

青鹏软膏基质

样本量:

30

Group:

Qingpeng ointment base

Sample size:

干预措施:

外用青鹏膏基质于患处, 每日2 次。

干预措施代码:

Intervention:

apply Qingpeng ointment base, bid

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京友谊医院皮肤科 

单位级别:

三级甲等综合性医院 

Institution
hospital:

Department of Dermatology, Beijing Friendship Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

受试者瘙痒程度自我评价

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

EASI评分

指标类型:

主要指标 

Outcome:

EASI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

四条目瘙痒问卷

指标类型:

主要指标 

Outcome:

Four-item itch questionnaire

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

由生物统计学家在计算机上用SAS统计软件包进行随机排列产生随机数字,每一个病人严格按照入选时间顺序得到一个序号,据此编号分组。

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

By a biostatistician on the computer random generate random Numbers using SAS statistical software package, each patient in strict accordance with the selected time sequence to get a serial number, number group accordingly.

盲法:

Blinding:

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):

留存首都医科大学附属北京友谊医院皮肤科,通过ResMan共享

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

IPD will be public accessable via ResMan, and diposited in Department of Dermatology, Beijing Friendship Hospital, Capital Medical University

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:

应用SPSS23.0统计软件

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

SPSS23.0

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-05-17
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