Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 342
- 主要终点
- Change from Baseline in the Eczema Area and Severity Index (EASI) score
研究概览
简要总结
On the basis of Xiashi skin surgery clinical experience, this project adopts the multicenter, randomized, double-blind, controlled trial of design type. Objective, normative evaluation of traditional Chinese medicine cool blood latent town effectiveness of therapeutic regimen in the treatment of eczema, security, and control of the relapse of situation, provide high-level evidence-based basis for traditional Chinese medicine treatment of eczema, aims to form suitable for popularization and application of traditional Chinese medicine in the treatment of eczema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •accord with standard of syndrome differentiation of traditional Chinese medicine (blood hot sheng) and western medicine diagnostic criteria (subacute eczema);
- •age between 18-65 years old, gender, ethnic unlimited;
- •agreed to participate in clinical trials can observe and cooperate with the visitor on schedule;
- •volunteered for this study and obtain informed consent will be;
- •lesion area of about 5-30% of surface area (BSA) were (containing 3% and 3%, palm measurement method)
- •IGA scale of 1 to 3 points (including);
- •her lesions mainly located in the trunk and limbs (or);
- •Women HCG negative;
排除标准
- •known to the study of drug allergy to any of the components;
- •previous or current with any may affect the results of systemic disease, or other activity of skin diseases (such as: psoriasis);
- •has a liver and kidney function is not complete, liver damage of ALT and AST > 1.5 times the upper limit of normal, renal BUN > 1.5 times the upper limit of normal or creatinine > 1.5 times the upper limit of normal value;
- •QTcB or QTcF acuity 450 milliseconds. For subjects QTc acuity bundle branch block 480 milliseconds.
- •prior or current with clinical significance of cardiovascular, lung disease, gastrointestinal tract, liver, kidney, blood, nerve abnormalities or mental disease;
- •breast-feeding or plan to pregnant women during test;
- •skin area score > 30%;
- •eosinophil count score > 10%
- •for nearly two weeks taking corticosteroids or a week, both inside and outside with corticosteroid preparation;
- •three months received study medication or other participated in other clinical subjects;
- •for any reason cannot cooperate research, for example: how language understanding, not to research centers, etc.;
- •Researchers believe can bring obvious risk patients or confuse the results of the study, which should rule out other conditions or disease.
研究组 & 干预措施
Qinzhuliangxue Keli
Qinzhuliangxue Keli(common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets placebo (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.)
干预措施: Furoic acid loperamide hydrochloride cream (Drug)
Qinzhuliangxue Keli
Qinzhuliangxue Keli(common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets placebo (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.)
干预措施: Mullite ointment (Drug)
Qinzhuliangxue Keli
Qinzhuliangxue Keli(common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets placebo (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.)
干预措施: 3% boric acid solution (Drug)
Qinzhuliangxue Keli
Qinzhuliangxue Keli(common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets placebo (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.)
干预措施: Zine oxide (Drug)
loratadine tablets
Qinzhuliangxue Keli placebo (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.),Loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
干预措施: Furoic acid loperamide hydrochloride cream (Drug)
loratadine tablets
Qinzhuliangxue Keli placebo (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.),Loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
干预措施: Mullite ointment (Drug)
loratadine tablets
Qinzhuliangxue Keli placebo (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.),Loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
干预措施: 3% boric acid solution (Drug)
loratadine tablets
Qinzhuliangxue Keli placebo (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.),Loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
干预措施: Zine oxide (Drug)
Qinzhuliangxue and loratadine
Qinzhuliangxue Keli (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
干预措施: Furoic acid loperamide hydrochloride cream (Drug)
Qinzhuliangxue and loratadine
Qinzhuliangxue Keli (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
干预措施: Mullite ointment (Drug)
Qinzhuliangxue and loratadine
Qinzhuliangxue Keli (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
干预措施: 3% boric acid solution (Drug)
Qinzhuliangxue and loratadine
Qinzhuliangxue Keli (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
干预措施: Zine oxide (Drug)
结局指标
主要结局
Change from Baseline in the Eczema Area and Severity Index (EASI) score
时间窗: Baseline and up to week 4 of the follow up phase
次要结局
- Change in Itching degree score(Baseline and up to week 4 of the follow up phase)
- Dermatology life quality index (DLQI)(Baseline and up to week 4 of the follow up phase)