NCT03293225已完成不适用
A Randomized Open Labeled Trial to Compare the Efficacy of Antihistamine Dosing-up and add-on Treatment With H2-receptor Antagonist in Patients With Chronic Urticaria
Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年8月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of evaluation after 4 weeks treatment by a investigator
研究概览
简要总结
A randomized open labeled trial to compare the efficacy of antihistamine dosing-up and add-on treatment with H2-receptor antagonist in patients with chronic urticaria
详细描述
- For four weeks
- After the researcher confirms the selection / exclusion criteria on the baseline, the UAS, K-UCT, and CU-QoL are created and randomized from the subject.
- Receive UAS, K-UCT, and CU-QoL from the subject during the last visit to assess safety
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents and adults over 12 years
- •Clinical diagnosis of chronic urticaria due to wheal reaction, itching, angioedema over 6 weeks
- •Antihistamine 2 or 2 kinds of treatment for more than 2 weeks even if the symptoms are not controlled
- •Those who do not have other chronic skin diseases
排除标准
- 未提供
结局指标
主要结局
Number of evaluation after 4 weeks treatment by a investigator
时间窗: 4 weeks
0-no effective, 1-ineffective, 2-effective, 3-no symptoms
次要结局
- Number of evaluation as assessed by questionnaire(4 weeks)
- Number of urticaria symptom by UAS(4 weeks)
- Number of creatinine, AST/ALT(4 weeks)
- Peripheral blood eosinophil count(4 weeks)
- Number of urticaria control by K-UCT(4 weeks)
- Quality of life of chronic urticaria by CU-QoL(4 weeks)
- Number of Patient-controlled urticaria by VAS(4 weeks)
- Number of patients using emergency medication(4 weeks)
- Comparison of Serum total IgE(4 weeks)
- Number of physiological parameter(4 weeks)
研究者
Ye Youngmin
professor, Department alleric internal medicine
Ajou University School of Medicine
研究点 (1)
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