今天是:2017-05-25 星期四

普连膏治疗血热型银屑病的多中心、随机、双盲、安慰剂对照临床研究
下载XML文档

注册号:

Registration number:

ChiCTR-TRC-12002054 

最近更新日期:

Date of Last Refreshed on:

2015-08-08 

注册时间:

Date of Registration:

2012-03-27 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

普连膏治疗血热型银屑病的多中心、随机、双盲、安慰剂对照临床研究 

Public title:

Pulian Ointment in Treating Psoriasis of Blood-Heat Syndrome: a multi-center randomized, double-blind, placebo-controlled clinical study 

研究课题的正式科学名称:

普莲膏治疗血热型银屑病的安全性和有效性临床研究 

Scientific title:

safety and efficacy of clinical research of Pulian Ointment in Treating Psoriasis of Blood-Heat Syndrome 

研究课题代号(代码):

Study subject ID:

2008BAI53B044 

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:

李锘 

研究负责人:

白彦萍 

Applicant:

Nuo Li 

Study leader:

Yanping Bai 

申请注册联系人电话:

Applicant telephone:

+86 15801238436 

研究负责人电话:

Study leader's telephone:

+86 13910758509 

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:

nola8316@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

zhi@tsinghua.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.zryhyy.com.cn 

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:

北京市朝阳区樱花园东街2号中日友好医院皮肤科 

研究负责人通讯地址:

北京市朝阳区樱花园东街2号中日友好医院皮肤科 

Applicant address:

2 East Yinghua Road, Chaoyang District, Beijing, China 

Study leader's address:

2 East Yinghua Road, Chaoyang District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100029 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中日友好医院 

Applicant's institution:

China-Japan Friendship Hospital 

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:

2010-31 

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:

中日友好医院药物临床试验伦理委员会 

Name of the ethic committee:

China-Japan friendship hospital clinical research ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2010-04-23 

研究实施负责(组长)单位:

广州中医药大学 

Primary sponsor:

Traditional Chinese Medicine University Of Guangzhou 

研究实施负责(组长)单位地址:

广州市白云区机场路12号 

Primary sponsor's address:

12 Jichang Road, Baiyun district, Guangzhou 

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):

中日友好医院

具体地址:

北京市朝阳区樱花园东街2号

Institution
hospital:

China-Japan Friendship Hospital

Address:

2 East Yinghua Road, Chaoyang District, Beijing, China

经费或物资来源:

十一五国家科技支撑计划项目 

Source(s) of funding:

the National Key Technology R&D Program for the 11th five-year plan 

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:

其它 

Study phase:

Other 

研究目的:

验证符合国家法规的纯中药制剂普连膏干预血热型银屑病的疗效及安全性。 

Objectives of Study:

Verify compliance with state laws and regulations of pure Chinese herbal medicine Pulian Ointment in Treating Psoriasis of Blood-Heat Syndrome safety and efficacy 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

a. 18-65周岁门诊或住院的寻常型银屑病患者; b. 符合中医银屑病血热证诊断标准者; c. 近1个周未经治疗者; d. 签署知情同意书者; e. 皮损面积在30%以内者。 

Inclusion criteria

1. outpatient or hospital patients with psoriasis vulgaris who are 18 to 65 years old; 2. Accord with Traditional Chinese medicine with psoriasis blood heat syndromes diagnosis standards; 3. Nearly a week without treatment; 4. Sign informed consent certificates; 5. lesions less than 30% area of the body. 

排除标准:

a. 感染、妊娠、分娩、外伤等应激状态者; b. 近1个周内系统应用或局部外用皮质类固醇激素及免疫抑制剂者; c. 严重心、肝肾疾病及精神病患者 d. 曾经有对本药中任何一种中药或基质成分有全身或局部接触过敏者; e. 关节型、脓疱型、红皮病型银屑病。 

Exclusion criteria:

1. Pregnancy and childbirth infections and trauma stress situation; 2. person who accepted system application or local topical corticosteroids and immunosuppressant nearly one week; 3. person who has severe kidney disease and heart mental illness; 4. person who was systemic or local contact allergy with any of this medicine or matrix components; 5. arthropathic,Pustular or erythrodermic psoriasis. 

研究实施时间:

Study execute time:

From2010-06-01To 2012-04-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

150

Group:

treatment group

Sample size:

干预措施:

普连膏

干预措施代码:

Intervention:

Pulian Ointment

Intervention code:

组别:

对照组

样本量:

150

Group:

control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

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):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

中日友好医院 

单位级别:

三级甲等 

Institution
hospital:

China-Japan Friendship Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

广安门医院 

单位级别:

三级甲等 

Institution
hospital:

Guang An Men Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

东直门医院 

单位级别:

三级甲等 

Institution
hospital:

Dongzhimen Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

东方医院 

单位级别:

三级甲等 

Institution
hospital:

Dongfang Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京中医医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

中国人民解放军空军总医院 

单位级别:

三级甲等 

Institution
hospital:

The Chinese people's liberation army air force general hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

PASI评分

指标类型:

主要指标 

Outcome:

PASI scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮损单项症状评价

指标类型:

主要指标 

Outcome:

lesions single symptoms evaluation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘙痒等级评分

指标类型:

主要指标 

Outcome:

Itch ratings

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿焦虑量表

指标类型:

主要指标 

Outcome:

HAMA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分

指标类型:

主要指标 

Outcome:

quality of life score symptom score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证侯评分

指标类型:

次要指标 

Outcome:

TCM syndrome score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

依从性评价

指标类型:

附加指标 

Outcome:

Compliance evaluation

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

合并用药

指标类型:

附加指标 

Outcome:

drug combination

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

Adverse Events

Type:

Adverse events 

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:

副作用指标 

Outcome:

blood routine

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标 

Outcome:

Routine urinalysis

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能监测

指标类型:

副作用指标 

Outcome:

tests of the liver and kidney functions

Type:

Adverse events 

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 18 years
最大 Max age 65 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

北京中医药大学循证医学中心 中心区组随机

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

Beijing university of Chinese medicine evidence-based medical center Center of random

盲法:

双盲

Blinding:

Double blind

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):

中日友好医院

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

China-Japan Friendship Hospital

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

北京中医药大学循证医学中心

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Beijing university of Chinese medicine evidence-based medical center

注册人:

Name of Registration:

 2012-03-27
返回列表