Sequential comparison of bliastine with cetirizine or fexofenadine in chronic spontaneous urticaria

Department of Dermatology1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2020年6月25日最近更新: 2021年10月12日

试验速览

阶段: 不适用
状态: 招募中
发起方: Department of Dermatology
入组人数: 44
试验地点: 1
主要终点: To study the clinical efficacy of bliastine in Indian population and compare its efficacy with cetirizine or fexofenadine in chronic spontaneous urticaria.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Urticaria is a common dermatological disease. The mainstay of treatment is antihistamines. Bilastine is a newly approved drug for chronic spontaneous urticara in India in 2019. There is a paucity of studies comparing its efficacy and side effect profile with anti histamines like cetirizine and fexofenadine, especially in an Indian population. This study aims to study the efficacy of bilastine in Indian population as well as compare its efficacy with cetirizine or fexofenadine , and compare their side effect profile.

研究设计

研究类型: Interventional
分配方式: Random Number Table
盲法: Not Applicable

入排标准

年龄范围: 12.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•1.Patients with chronic spontaneous urticaria , wheals and pruritis persiting for most of the days , for more than 6 weeks
•patients more than 12 years of age.

排除标准

•1.Patients taking systemic steroid or immunosuppressive therapy in the last 2 weeks
•Patients with severe life threatening illness
•Pregnant and lactating mothers.

结局指标

主要结局

To study the clinical efficacy of bliastine in Indian population and compare its efficacy with cetirizine or fexofenadine in chronic spontaneous urticaria.

时间窗: 0,1,2,3,4,5,6 weeks

次要结局

To compare adverse effects of bilastine with cetirizine or fexofenadine in chronic spontaneous urticaria.(0,1,2,3,4,5,6 weeks)

研究者

发起方

Department of Dermatology

申办方类型

Government medical college

研究点 (1)

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