CTRI/2020/03/024244已完成4 期
A comparative, three arm, randomized clinical trial to evaluate the effectiveness and tolerability of Bilastine vs Fexofenadine vs Levocetrizine at standard dose and Bilastine vs Fexofenadine at higher than standard dose (Up dosing) vs Levocetrizine & Hydroxyzine (in combination) in patients with chronic spontaneous urticaria.
B J Medical College Civil Hospital0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Both males and females patients aged ââ?°Â¥ 18 years and ââ?°Â¤ 60 years
- •2.Patients with H/O CSU
- •3.UAS7 of ââ?°Â¥7 at baseline
- •4.Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol.
- •5.Patients who the study staff deems reliable and mentally competent to carry out the study.
排除标准
- •1.Patients with physical urticaria (e.g. solar, heat, cold, aquagenic, cholinergic, contact, pressure, etc.), drug-induced urticaria, urticarial vasculitis, senile pruritus or hereditary angioedema.
- •2.Patients with any other dermatological condition associated with pruritus.
- •3.Pregnant or nursing females.
- •4.Patients with known hypersensitivity to the study drugs.
- •5.Patients with immunosuppressive disease or on immunosuppressive drugs.
- •6.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectââ?¬•s safety or interfere with the study assessments.
- •7.Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the patientââ?¬•s ability to safely complete the study.
- •8.History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •9.Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
研究者
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