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Muticenter, ranfdomized and controllrd clinicl study for Haoqin Huaban Prescription in the treatment of polymorphous light eruption
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注册号:

Registration number:

ChiCTR1900026777 

最近更新日期:

Date of Last Refreshed on:

2019-10-21 

注册时间:

Date of Registration:

2019-10-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

侯雨彤医师:请上传完整版伦理审批文件。 蒿秦化斑方治疗多形性日光疹的多中心随机对照临床研究 

Public title:

Muticenter, ranfdomized and controllrd clinicl study for Haoqin Huaban Prescription in the treatment of polymorphous light eruption 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

蒿秦化斑方治疗多形性日光疹的多中心随机对照临床研究 

Scientific title:

Muticenter, ranfdomized and controllrd clinicl study for Haoqin Huaban Prescription in the treatment of polymorphous light eruption 

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:

侯雨彤 

研究负责人:

孙丽蕴 

Applicant:

Yutong Hou 

Study leader:

Liyun Sun 

申请注册联系人电话:

Applicant telephone:

+86 15210130345 

研究负责人电话:

Study leader's telephone:

+86 13521779789 

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:

331479204@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

doctorsunny@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:

北京市东城区美术馆后街23号 

研究负责人通讯地址:

北京市东城区美术馆后街23号 

Applicant address:

23 Art Gallery Back Street, Dongcheng District, Beijing 

Study leader's address:

23 Art Gallery Back Street, Dongcheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

首都医科大学附属北京中医医院 

Applicant's institution:

Beijing Hospital of Traditional Chinese Medcine of Captial 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:

2019BL02-023-01 

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中医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medcine of Captial Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-19 

伦理委员会联系人:

王晶 

Contact Name of the ethic committee:

Jing Wang 

伦理委员会联系地址:

北京市东城区美术馆后街23号 

Contact Address of the ethic committee:

23 Art Gallery Back Street, Dongcheng District, Beijing 

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 Traditional Chinese Medcine of Captial Medical University 

研究实施负责(组长)单位地址:

北京市东城区美术馆后街23号 

Primary sponsor's address:

23 Art Gallery Back Street, Dongcheng District, Beijing 

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:

东城区美术馆后街23号

Institution
hospital:

Beijing Hospital of Traditional Chinese Medcine of Captial Medical University

Address:

23 Art Gallery Back Street, Dongcheng District

经费或物资来源:

首都医科大学附属北京中医医院 

Source(s) of funding:

Beijing Hospital of Traditional Chinese Medcine of Captial Medical University 

研究疾病:

多形性日光疹 

Target disease:

Polymorphous Light Eruption 

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:

探索性研究/预试验 

Study phase:

研究目的:

以随机、双盲对照的科学、规范方法,观察以清热凉血解毒为法的蒿秦化斑方治疗光毒侵袭证多形性日光疹的临床有效性并进行安全性评价。 

Objectives of Study:

To observe the clinical efficacy and safety of the haoqinhuaban fang ,removing heat to cool blood to cure polymorphous light eruption by using randomized and double blind controlled methouds under the guidance of scientific and normative. 

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、符合西医多形性日光疹诊断标准; 2、符合中医光毒侵袭证“日晒疮”证候诊断标准; 3、年龄18~65岁。 4、病情严重程度:5cm2<皮疹面积<50cm2。  

Inclusion criteria

1. It conforms to the diagnostic standard of polymorphous light eruption in western medicine. 2. It conforms to the diagnostic standard of "solar dermatitis" in traditional chinese medcine. 3. Aged between 18 to 65 years; 4. Severity of illness:5cm2

排除标准:

1、暴露部位的其他炎症性皮肤病,如染发皮炎、接触性皮炎等; 2、患有光敏感性增加的系统性疾病如红斑狼疮、皮肌炎等; 3、合并心脑血管、肝肾、内分泌、造血系统等严重原发性疾患,或精神疾患等影响实验完成者; 4、妊娠或哺乳妇女; 5、已知或可疑对研究药物成分过敏者; 6、伴呼吸困难、胸闷、心悸、气促、恶心、呕吐、头晕等其他系统不适症状者; 7、正在参加其他药物临床试验的患者; 8、研究者认为不宜参加本试验者。 

Exclusion criteria:

1. Other inflammatory skin diseases at exposed sites:hair dye dermatitis,contact dermatitis,etc. 2. Suffer from the systemic disease such as lupus erythematosus and dermatomyositis,which increase photosensitivity. 3. Combine the serious primary disorders like heart and cerebral vessels disease,liver and kindey disease,internal secretion disease, hemtopoiesis systematic disease,etc.Or mental disease will influence the experiment. 4. Pregnancy or nursing woman. 5. Patient who suspicious or known allergy to the ingredient of the experiment herbs. 6. Other systemic disease accompanied with dyspnea,chest distress,palpitation,anhelation,nausea,emesis and swirl,ect. 7. In process of other clincial medicine experiment. 8. Trier who is inappropriate this reaserch. 

研究实施时间:

Study execute time:

From2019-12-01To 2022-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

84

Group:

experimental group

Sample size:

干预措施:

内服蒿秦化斑方

干预措施代码:

Intervention:

Having Chinese Herbs (Haoqin Huaban prespcription)

Intervention code:

组别:

对照组

样本量:

42

Group:

control group

Sample size:

干预措施:

内服安慰剂

干预措施代码:

Intervention:

Having 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):

 

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:

三甲 

Institution
hospital:

Beijing Hospital of Traditional Chinese Medcine of Captial Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医医院顺义医院 

单位级别:

三甲 

Institution
hospital:

Shunyi Campus of Beijing Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市回民医院 

单位级别:

三甲 

Institution
hospital:

Beijing Hui People Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

湿疹皮损面积与严重程度指数

指标类型:

主要指标 

Outcome:

Eczema 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:

中医主要临床证候评分指标

指标类型:

主要指标 

Outcome:

Main Clinical Syndrome Scoring Index of TCM

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤屏障测定

指标类型:

主要指标 

Outcome:

Skin barrier measurement

Type:

Primary indicator 

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:

主要指标 

Outcome:

blood routine examination

Type:

Primary indicator 

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:

主要指标 

Outcome:

routine urine test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

主要指标 

Outcome:

liver function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

主要指标 

Outcome:

renal function

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:

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

用计算机统计软件产生随机数字和相应的药品编码,医生按随机号开出符合入组程序的处方,写明受试者的随机号。受试者持专用处方领取药品。发药人员核对处方并登记后,发放相应药物,并强调用药注意事项,受试者签字领药。

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

1.get random number and relevant medicine number by using the statistical software. 2.doctor giving the group treatment herbs with the random number, number the trier at the meantime. 3.trier get the herbs with special recipe. 4.trier can get the medcine by checking the recipe from deliveryman,listening the announc

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

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

none

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:

每位入组患者均需填写CRF报表,以记录患者在研究中的病情变化和各项数据指标。

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

every trier needs to set a case record form during the research which requires to record the index carefully.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-21
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