A Prospective Randomized Non-blinded Study of Safety and Efficacy of Bilastine Up-dosing (40 mg) Versus Combination of Bilastine (20 mg) With Levocetrizine (5mg) in the Treatment of Chronic Spontaneous Urticaria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in urticaria severity score (UAS7)
研究概览
简要总结
This study aims to compare the effectiveness and safety of two commonly used antihistamines, bilastine 20 mg and levocetirizine 5 mg, in patients diagnosed with chronic urticaria. Chronic urticaria is a skin condition characterized by recurrent itchy wheals that significantly affect quality of life.
Eligible participants will be randomly assigned to receive either bilastine or levocetirizine for a defined treatment period. The severity of symptoms, improvement in itching and wheals, and any adverse effects will be assessed during follow-up visits.
The results of this study will help determine which treatment provides better symptom control with fewer side effects in patients with chronic urticaria.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of CSU as per operational definitions.
- •Patients already taking Bilastine 20 mg and still getting new lesions.
- •UAS7 score >3
- •Age range of 18-70 years
- •Both male and female patients
排除标准
- •• women Patients who have already received treatment of CSU other than Bilastine.
- •Patients taking oral or topical corticosteroids
- •Pregnant or lactating
- •Patients with hereditary angioedema, atopic dermatitis, systemic immune disorders, collagen vascular diseases, immunocompromised status, Chronic liver or kidney failures
研究组 & 干预措施
Group A (tab bilastine 40mg )
patients received oral tab bilastine 20 mg twice daily for 6 weeks
干预措施: tab bilastine 20 mg (Drug)
Group B ( tab bilastine 20 mg + tab levocetrizine 5 mg )
patients received tab bilastine 20 mg in the morning and tab levocitrizine 5 mg in the evening for 6 weeks
干预措施: tab bilastine 20 mg + tab levocetrizine 5 mg (Drug)
结局指标
主要结局
change in urticaria severity score (UAS7)
时间窗: baseline to 6 weeks
change in urticaria severity score (UAS7) from baseline to 6 weeks UAS7 is a validated composite score assessing daily wheal number and pruritis severity over 7 consecutive days ,with total scores ranging from 0 to 42. Higher scores indicate more severe urticaria activity and a reduction in score reflects clinical improvement.
次要结局
未报告次要终点