注册号: Registration number: |
ChiCTR1800016190 |
最近更新日期: Date of Last Refreshed on: |
2018-05-17 |
注册时间: Date of Registration: |
2018-05-17 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
青鹏软膏在局限性非渗出性湿疹中的止痒作用及治疗前后细胞因子改变情况的分析 |
Public title: |
The antipruritic effect of qingpeng ointment in the localized non-exudative eczema and the changes of cytokines before and after treatment. |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
青鹏软膏在局限性非渗出性湿疹中的止痒作用及治疗前后细胞因子改变情况的分析 |
Scientific title: |
The antipruritic effect of qingpeng ointment in the localized non-exudative eczema and the changes of cytokines before and after treatment. |
研究课题代号(代码): Study subject ID: |
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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: |
徐薇 |
研究负责人: |
徐薇 |
Applicant: |
XU WEI |
Study leader: |
XU WEI |
申请注册联系人电话: Applicant telephone: |
+86 18611015100 |
研究负责人电话: Study leader's telephone: |
+86 18611015100 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
2403649155@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
2403649155@qq.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): |
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申请注册联系人通讯地址: |
中国 北京市西城区永安路95号 |
研究负责人通讯地址: |
中国 北京市西城区永安路95号 |
Applicant address: |
95 Yong'an Road, Xicheng District, Beijing, China |
Study leader's address: |
95 Yong'an Road, Xicheng District, Beijing, China |
申请注册联系人邮政编码: Applicant postcode: |
100050 |
研究负责人邮政编码: Study leader's postcode: |
100050 |
申请人所在单位: |
首都医科大学附属北京友谊医院皮肤科 |
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Applicant's institution: |
Department of Dermatology, Beijing Friendship Hospital, Capital Medical University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2017-P2-159-01 |
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友谊医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee, Beijing Friendship Hospital, Capital Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2013-08-26 | ||
伦理委员会联系人: |
李悦 |
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Contact Name of the ethic committee: |
LiYue |
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伦理委员会联系地址: |
首都医科大学附属北京友谊医院科研处 |
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Contact Address of the ethic committee: |
95 Yong'an Road, Xicheng District, Beijing, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 13661202501 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
13661202501@163.com |
研究实施负责(组长)单位: |
首都医科大学附属北京友谊医院皮肤科 |
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Primary sponsor: |
Department of Dermatology, Beijing Friendship Hospital, Capital Medical University |
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研究实施负责(组长)单位地址: |
北京市西城区永安路95号 |
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Primary sponsor's address: |
95 Yong'an Road, Xicheng District, Beijing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
中国中西医结合学会皮肤性病专业委员会 |
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Source(s) of funding: |
Dermatological Subcommittee of China Society of Integrated Traditional Chinese and Western Medicine |
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研究疾病: |
限局性湿疹 |
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Target disease: |
localized eczema |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
上市后药物 | ||||||||||||||||||||||
Study phase: |
4 |
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研究目的: |
初步探讨青鹏软膏治疗湿疹、缓解瘙痒的作用机制 |
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Objectives of Study: |
The mechanism of qingpeng ointment in treating eczema and alleviating itchiness is discussed. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
年龄18-65岁,男女不限;诊断符合局限性非渗出性湿疹,体表面积1%-15%;病程不限;无明显诱因;已阅读了受试者须知,同意并签署书面知情同意书。 |
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Inclusion criteria |
1. aged from 18-80 years male and female; 2. Clinically Diagnosed localized chronic eczema, Skin involvement for 1% to 15% of body surface areapatients; 3. The disease has no obvious cause; 4. Participant fully understands the content of the clinical trial, is willing to attend the research voluntary andsign the informed consent form. |
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排除标准: |
已知对试验及对照药物过敏者;严重肝肾疾病,血液系统疾病,自身免疫病,慢性严重感染,糖尿病,精神病、恶性肿瘤或其他可能影响正确评估疗效的严重疾病者;局部用皮质类固醇停药时间小于2周;系统用皮质类固醇及其它免疫抑制剂(雷公藤等)停药时间小于4周;面部及皮肤皱褶部位湿疹;皮损总面积超过体表面积的15%或低于1%;研究者认为不宜入选的其他原因。 |
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Exclusion criteria: |
1. allergic to the study drugs; 2. with severe disease in the liver, kidney, and/or blood; with autoimmune diseases, chronic serious infection, diabetes, mental diseases, substance abuse, and/or alcoholic; with the malignant tumor or other serious diseases that may compromise the accuracy of efficacy evaluation for the study drug; 3. apply corticosteroids cream within 2 weeks; have taken systemic corticosteroids or other systemic immune inhibitors (e.g. Tripterygium wilfordii et al.) within 4 weeks; 4. rash on face, skin folds such as anus, vulva; 5. Skin lesions with a total area of more than 15% of the body surface area or less than 1%; 6. other reasons that researchers think that should not be selected. |
研究实施时间: Study execute time: |
从From2018-05-17至To 2018-06-30 |
征募观察对象时间: Recruiting time: |
从From2018-05-17至To 2018-06-17 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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