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regulation in psoriasis
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注册号:

Registration number:

ChiCTR1800016573 

最近更新日期:

Date of Last Refreshed on:

2018-06-10 

注册时间:

Date of Registration:

2018-06-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

银屑病调控 

Public title:

regulation in psoriasis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于T淋巴细胞分化的miR-451转录调控研究凉血解毒方治疗银屑病的作用机理 

Scientific title:

To study the mechanism of the blood-heat clearing and detoxicating formula in psoriasis from the view of transcriptional regulation of miR-451 during T cell differentiation 

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:

李亚俊 

研究负责人:

李亚俊 

Applicant:

Yajun Li 

Study leader:

Yajun Li 

申请注册联系人电话:

Applicant telephone:

+86 010 52176965 

研究负责人电话:

Study leader's telephone:

+86 010 52176965 

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:

liyj1102big@126.com 

研究负责人电子邮件:

Study leader's E-mail:

liyj1102big@126.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:

北京东城美术馆后街23号,研究所 

研究负责人通讯地址:

北京东城美术馆后街23号,研究所 

Applicant address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

Study leader's address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100010 

研究负责人邮政编码:

Study leader's postcode:

100010 

申请人所在单位:

首都医科大学附属北京中医医院, 北京市中医研究所  

Applicant's institution:

Beijing Institution of TCM, Beijing Hospital of TCM affliated to CMU  

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:

2018BL_006_02 

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中医医院医学伦理委员会 

Name of the ethic committee:

Medical Ethical Commitee of Beijing Hospital of TCM affliated to Capital Medical Unicersity  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-12 

伦理委员会联系人:

王晶 

Contact Name of the ethic committee:

Jin Wang 

伦理委员会联系地址:

北京东城美术馆后街23号 

Contact Address of the ethic committee:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China 

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:

首都医科大学附属北京中医医院 

Primary sponsor:

Beijing Hospital of TCM affliated to CMU  

研究实施负责(组长)单位地址:

北京东城美术馆后街23号 

Primary sponsor's address:

23 Back Street of Art Gallery, Dongcheng 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中医医院

具体地址:

北京东城美术馆后街23号

Institution
hospital:

Beijing Hospital of TCM affliated to CMU

Address:

23 Back Street of Art Gallery, Dongcheng District, Beijing, China

经费或物资来源:

国家自然科学基金委 

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:

基础科学研究 

Study type:

Basic science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

研究银屑病发病的分子机制以及凉血解毒治疗银屑病血热证的作用机制。 

Objectives of Study:

To study the pathogenesis of psoriasis and the mechanism of the Blood-heat clearing decoction in treating psoriasis from the view of microRNA regulatory role in T cell differentiation . 

药物成份或治疗方案详述:

针对辨证为血热证的银屑病患者服用凉血解毒方8周,每2周复诊。 

Description for medicine or protocol of treatment in detail:

For blood heat type psoriasis, LXJD decoction were administrated for 8 weeks,reexamination every 2 weeks 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

纳入标准:A: 银屑病组 : 1) 符合西医银屑病诊断标准; 2) 年龄在18岁至65岁;3)签署知情同意书,志愿受试;4)其中血热证患者符合银屑病的中医血热证辨证标准。 B:正常组 1)健康志愿者;2)年龄在18岁至65岁; 3)签署知情同意书。 

Inclusion criteria

The included individuals must comply with all the following criteria; 1. Psoriasis group: 1) Meeting the clinical diagnosis criteria of psoriasis; 2) Male or female patients aged; 3) Aged 18-65 years old; 4) Written informed consent for participating; 5)For blood-heat type psoriasis, meeting the clinical diagnosis criteria of psoriasis blood-heat syndromes of T.C.M.; 2. Control group: 1) Healthy, nonpsoriatic volunteers; 2) Male or female patients aged 18-65 years old; 3) Written informed consent for participating. 

排除标准:

1)不属于银屑病,或者辨证不明确者;2)妊娠或哺乳期妇女,三个月内有生育计划者;3) 近一个月内服类固醇类药物、免疫抑制剂类药物、 和/或维甲酸类药物或2周内外用过类固醇制剂、维甲酸类药物及维生素D3衍生制剂;4)合并心、脑血管、肝、肾和造血系统等严重原发性疾病、精神病患者;有其他自身免疫性疾病者;5)伴皮肤肿瘤;6)关节型、脓疱型、红皮病型银屑病;7)对研究药物过敏者.  

Exclusion criteria:

1) Obscure in syndrome differentiation, not belonging to blood-heat syndromes; 2) Pregnant and lactating women; 3) Taking corticosteroids, phototherapy, systemic therapies and other T.C.M. treatment within 4 weeks; Use of corticosteroids, vitamin D analogues, keratolytics or coal tar within 2 weeks; 4) Renal or liver impairment, active infection, immunosuppression or other serious concomitant illness; 5) Accompany with skin tumor; 6) Patients with erythrodermic, pustular, and only palmoplantar forms of psoriasis, and patients with psoriatic arthritis were excluded; 7) Allergic to components of the decoction.  

研究实施时间:

Study execute time:

From2018-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

血热组

样本量:

30

Group:

Blood heat type

Sample size:

干预措施:

凉血解毒方

干预措施代码:

Intervention:

LiangXueJieDu Decoction

Intervention code:

组别:

非血热证组

样本量:

30

Group:

non-blood-heat psoriasis

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

健康组

样本量:

15

Group:

healthy control 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):

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医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital of TCM affliated to CMU  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

银屑病面积和严重程度指数

指标类型:

主要指标 

Outcome:

PASI (psoriasis area and severity index)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

T 淋巴细胞亚群分析

指标类型:

主要指标 

Outcome:

T cell subset

Type:

Primary indicator 

测量时间点:

测量方法:

FACS

Measure time point of outcome:

Measure method:

指标中文名:

基因表达

指标类型:

主要指标 

Outcome:

gene expression

Type:

Primary indicator 

测量时间点:

测量方法:

RT-PCR

Measure time point of outcome:

Measure method:

指标中文名:

分子病理

指标类型:

主要指标 

Outcome:

molecular pathology

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:

血液

组织:

皮肤

Sample Name:

blood

Tissue:

skin

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

皮肤

组织:

Sample Name:

skin

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet 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):

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

none

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

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):

文章发表

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

publication

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:

CRF and EDC

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

CRF and EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-06-10
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