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耳穴贴压加西药局部用药治疗寻常型银屑病的随机对照研究
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注册号:

Registration number:

ChiCTR-TRC-14004916 

最近更新日期:

Date of Last Refreshed on:

2016-09-24 

注册时间:

Date of Registration:

2014-05-20 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

耳穴贴压加西药局部用药治疗寻常型银屑病的随机对照研究 

Public title:

A Randomized and Controlled Clinical Trial of Auricular Therapy with topical Western medicine in treatment for Psoriasis Vulgaris 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

耳穴贴压加西药局部用药治疗寻常型银屑病的随机对照研究 

Scientific title:

A Randomized and Controlled Clinical Trial of Auricular Therapy with topical Western medicine in treatment for Psoriasis Vulgaris 

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:

姚丹霓 

研究负责人:

卢传坚 

Applicant:

Danni Yao 

Study leader:

Chuanjian Lu 

申请注册联系人电话:

Applicant telephone:

+86 020-81887233-30603 

研究负责人电话:

Study leader's telephone:

+86 020-81887233 

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:

yaodanni1984@163.com 

研究负责人电子邮件:

Study leader's E-mail:

luchuanjian888@vip.sina.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:

广东省广州市大德路111号 

研究负责人通讯地址:

广东省广州市大德路111号 

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510120 

研究负责人邮政编码:

Study leader's postcode:

510120 

申请人所在单位:

广东省中医院 

Applicant's institution:

Guangdong Provincial Hospital of Traditional Chinese 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:

B2012-55-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Institutional Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-08-10 

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:

广东省中医院 

Primary sponsor:

Guangdong Provincial Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

广东省广州市大德路111号 

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

中医药治疗银屑病系列研究(广东省财政厅2011年) 

Source(s) of funding:

Series of studies of traditional Chinese medicine therapy for psoriasis(Guangdong Provincial Department of Finance in 2011) 

研究疾病:

寻常型银屑病 

Target disease:

psoriasis vulgaris 

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:

其它 

Study phase:

N/A 

研究目的:

采用双中心随机对照试验设计,对耳穴疗法叠加西医局部用药治疗进行效果评价,以了解耳穴疗法是否有提高疗效、缩短起效时间、减少复发次数、延缓复发时间、减少副作用、缓解瘙痒症状及提高银屑病患者生活质量的协同作用。同时检测银屑病患者治疗前后外周血中细胞因子表达水平,及治疗后细胞因子变化情况,并与正常对照组对比分析,揭示细胞因子在银屑病发病机制中所起作用以及中西医结合治疗寻常型银屑病对细胞因子的调节作用。 

Objectives of Study:

Design a randomized,single-blind and controlled clinical trial to explore the effect of the auricular therapy combined with topical Western medicine in treatment for psoriasis valguris. Moreover, test cytokine (TNF-alpha, IL-8, IL-10, IL-12, IL-17, IL-23) before and after the research by ELISA method to discover the relation of cytokines and psoriasis valguris. 

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年龄18-70岁。 ②7<PASI评分≤20分,且体表面积(BSA)<30%。 ③签署知情同意书者。 

Inclusion criteria

1. Aged 18 to 70 years old, male or female patients; 2. PASI more than 7 and less than 20, and BSA less than 30 %; 3. Inform consent. 

排除标准:

①关节型、脓疱型、红皮病型银屑病以及特殊部位银屑病,包括颜面、头皮、指甲、皱折、龟头、掌跖部位。 ②妊娠、哺乳期、月经过多,或1年内计划妊娠者。 ③心理测量量表SAS标准分>50分或SDS标准分>53分,或合并其他精神疾病的患者。 ④合并有循环系统、呼吸系统、消化系统、泌尿系统和造血系统等严重原发性疾病及肿瘤患者,及有严重感染、水、电解质及酸碱平衡紊乱的患者, 合并有钙代谢失调的患者。 ⑤已知对本研究中所用药物过敏、及含有相关药物成分(钙泊三醇、倍他米松)过敏的患者。 ⑥正在参加其它药物临床试验者或1个月内参加过其它临床试验者。 ⑦2周内曾用激素、维甲酸类等外用药物或紫外光治疗者;4周内曾接受系统治疗者;12周内曾使用生物制剂治疗者。 ⑧需进行西医系统治疗的患者。 

Exclusion criteria:

1. Patients who have a arthropathic, pustule or erythrodermic psoriasis as well as inverse psoriasis or exclusively involves the face; 2. Women who are pregnant, breastfeeding, or who are planning to get pregnant within 1 year; 3. SAS more than 50 or SDS more than 53, or with other psychiatric disorders; 4. With history of cardiovascular, respiratory, digestive, urinary, and hematologic disease, which cannot controlled through common treatment. Either with cancer, infection, electrolyte imbalance, acid-base disturbance and calcium metabolic disorder; 5. Allergic to any medicine or ingredients used in this study; 6. Participating other clinical trials or participated within 1 month; 7. Topical treatments (i.e. corticosteroids, Retinoic acid) within 2 weeks; systemic therapy or phototherapy (UVB and PUVA) within 4 weeks; biological therapy within 12 weeks; 8. Patients need systemic treatment prescribed by doctors. 

研究实施时间:

Study execute time:

From2012-08-01To 2014-12-30 

征募观察对象时间:

Recruiting time:

From2012-08-15To 2014-12-15 

干预措施:

Interventions:

组别:

试验组

样本量:

75

Group:

Intervention group

Sample size:

干预措施:

耳穴贴压加西药局部用药

干预措施代码:

Intervention:

Auricular therapy combined with topical Western m

Intervention code:

组别:

对照组

样本量:

75

Group:

control group

Sample size:

干预措施:

西药局部用药

干预措施代码:

Intervention:

topical Western medicine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Guangdong Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州市红十字会医院 

单位级别:

三级甲等医院 

Institution
hospital:

Guangzhou Red Cross Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州市番禺区慢性病防治站 

单位级别:

二甲医院 

Institution
hospital:

Chronic Disease Prevention and Control Station of Panyu District in Guangzhou  

Level of the institution:

Secondary A hospital 

测量指标:

Outcomes:

指标中文名:

银屑病的复发率

指标类型:

主要指标 

Outcome:

Relapse rate in treatment period/follow-up period

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

银屑病皮损面积与严重程度指数

指标类型:

主要指标 

Outcome:

Psoriasis Area and Severity Inde

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

复发间隔时间

指标类型:

次要指标 

Outcome:

Relapse time interval

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

起效时间

指标类型:

次要指标 

Outcome:

Onset time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

西药外用药用量

指标类型:

次要指标 

Outcome:

Cumulative consumption of topical western medicine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自评瘙痒评分

指标类型:

次要指标 

Outcome:

Pruritus Scores on the Visual Analogue Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤病生活质量评分

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:

肿瘤坏死因子

指标类型:

次要指标 

Outcome:

TNF

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-8

指标类型:

次要指标 

Outcome:

IL-8

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-17

指标类型:

次要指标 

Outcome:

IL-17

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-12

指标类型:

次要指标 

Outcome:

IL-12

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-23

指标类型:

次要指标 

Outcome:

IL-23

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-10

指标类型:

次要指标 

Outcome:

IL-10

Type:

Secondary 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:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

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 70 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):

计算机软件

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

computer software

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:

 2014-05-20
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