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基于核心病机治疗寻常型银屑病的临床研究
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注册号:

Registration number:

ChiCTR-TRC-13003233 

最近更新日期:

Date of Last Refreshed on:

2018-01-26 

注册时间:

Date of Registration:

2013-04-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于核心病机治疗寻常型银屑病的临床研究 

Public title:

Clinical study according to pathogenesis treatment for psoriasis vulgaris 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中药颗粒YXBCM01(PSORI-CM01)联合钙泊三醇倍他米松软膏与卡泊三醇软膏序贯疗法治疗寻常型银屑病的临床研究 

Scientific title:

Chinese Medicine Combined with Calcipotriol Betamethasone and Calcipotriol Ointment for Psoriasis Vulgaris: A Double-blind Randomised Controlled Trial 

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:

温泽淮 

研究负责人:

卢传坚 

Applicant:

Wen Zehuai 

Study leader:

Lu Chuanjian 

申请注册联系人电话:

Applicant telephone:

+86 13903008091 

研究负责人电话:

Study leader's telephone:

+86 13822250116 

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:

wenzehuai@139.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:

中国广东省广州市越秀区大德路111号 

研究负责人通讯地址:

中国广东省广州市越秀区大德路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 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:

B2012-53-03 

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 Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-16 

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 Chinese Medicine 

研究实施负责(组长)单位地址:

中国广东省广州市越秀区大德路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:

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

具体地址:

中国广东省广州市越秀区大德路111号

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine

Address:

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

经费或物资来源:

国家科学技术部 

Source(s) of funding:

The Ministry of Scinece and Technology, 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:

其它 

Study phase:

N/A 

研究目的:

评价中医药疗法结合西药局部用药治疗寻常型银屑病的临床疗效、安全性。 该临床研究开始前在广东省中医院进行了一个20例的小样本的临床预试验,干预措施为试验组:PSORI-CM01汤剂+钙泊三醇倍他米松软膏、卡泊三醇软膏;对照组:PSORI-CM01汤剂安慰剂+钙泊三醇倍他米松软膏、卡泊三醇软膏 

Objectives of Study:

To evaluate the clinical efficacy and safety of Chinese Medicine combined with calcipotriol betamethasone ointment and calcipotriol ointment for psoriasis valgaris. A pilot study was conducted before this trial, in which PSORI-CM 01 decoction + Calcipotriol Betamethasone and Calcipotriol Ointment compared with Placebo decoction + Calcipotriol Betamethasone and Calcipotriol Ointment. 

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18-65 岁。(2)稳定期的银屑病患者,皮损程度达到中重度(PASI>10 或BSA>10%,同时PASI<30 并且BSA<30%)。(3)签署知情同意书者。 

Inclusion criteria

(1) Aged 18 to 65 years old, male or female patients; (2) stationary stage, PASI> 10 or BSA > 10, meanwhile PASI<30 and BSA<30; (3) Infrom censent. 

排除标准:

(1)皮损以点滴状为主,或皮损单独见于颜面、头皮、指甲、皱折、龟头、粘膜、掌跖部位的患者。 (2)妊娠、哺乳期或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、内分泌系统和造血系统等严重原发性疾病、常规用药无法控制的患者,合并肿瘤的患者,有严重感染、水、电解质及酸碱平衡紊乱的患者,及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。 (7)2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)银屑病急性进展、有红皮病倾向的患者。 (9)需进行西医系统治疗的患者。 

Exclusion criteria:

(1) Guttate psoriasis, inverse psoriasis or exclusively involves the face; (2) Pregnant, lactating, or which one plan to become pregnant in a 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 can't 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) Acute progression of psoriasis, and erythroderma tendency; (9) Patients need systemic treatment prescribed by doctors. 

研究实施时间:

Study execute time:

From2013-05-01To 2017-12-31 

征募观察对象时间:

Recruiting time:

From2013-10-14To 2017-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

300

Group:

Intervention group

Sample size:

干预措施:

中药颗粒PSORI-CM 01+钙泊三醇倍他米松软膏、卡泊三醇软膏

干预措施代码:

Intervention:

PSORI-CM 01 granules+ Calcipotriol Betamethasone and Calcipotriol Ointment

Intervention code:

组别:

对照组

样本量:

300

Group:

Control group

Sample size:

干预措施:

安慰剂颗粒+钙泊三醇倍他米松软膏、卡泊三醇软膏

干预措施代码:

Intervention:

Placebo granules + Calcipotriol Betamethasone and Calcipotriol Ointment

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:

三甲 

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

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 

单位级别:

三甲 

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院广安门医院 

单位级别:

三甲 

Institution
hospital:

Guang'anmen Hospital,China Academy of Chinese Medical Sciences  

Level of the institution:

Tertiary A hospital 

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中医院 

单位级别:

三甲 

Institution
hospital:

Beijing Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属龙华医院 

单位级别:

三甲 

Institution
hospital:

LONGHUA Hospital Shanghai University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Automous Region 

City:

 

单位(医院):

新疆维吾尔自治区中医医院 

单位级别:

三甲 

Institution
hospital:

Traditional Chinese Medical Hospital of Xinjiang Uygur Automous Region  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江省中医研究院 

单位级别:

三甲 

Institution
hospital:

Heilongjiang Academy of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都中医药大学附属医院 

单位级别:

三甲 

Institution
hospital:

Teaching Hospital of Chengdu University of T.C.M,Sichuan Province Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市中西医结合医院 

单位级别:

三甲 

Institution
hospital:

Wuhan integrated TCM & Western Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

杭州市第三人民医院 

单位级别:

三甲 

Institution
hospital:

Hangzhou No.3 General 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):

广州中医药大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

No.1 Affiliated Hospital of Chinese MedicineGuangzhou University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市中医药研究院附属医院 

单位级别:

三甲医院 

Institution
hospital:

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

治疗和随访期间银屑病的复发率

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(PASI)

指标类型:

主要指标 

Outcome:

Psoriasis Area and Severity Index 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:

首次复发间隔时间

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:

反弹发生率

指标类型:

次要指标 

Outcome:

Rebound rate

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 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:

患者自评瘙痒评分

指标类型:

次要指标 

Outcome:

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:

皮损体表面积

指标类型:

次要指标 

Outcome:

the Body Surface Area

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:

the Dermatology Quality Life 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:

SF-36量表评分

指标类型:

次要指标 

Outcome:

SF-36 health survey

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:

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):

由广州中医药大学DME 中心人员采用SAS9.2 的PROC PLAN,完成程序编写和随机化的操作。

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

Programing and randomization operations will be performed by National Center for Training of Design

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:

 2013-04-15
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