Comparison of efficacy of fexofenadine and levocetirizine in treatment of chronic spontaneous urticaria-A non blinded randomized control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reducing itch severity and wheals number
研究概览
简要总结
After obtaining informed consent and fulfilling the inclusion
criteria, patients will be randomized into two groups as group A
and group B. GROUP A: Patients will receive tablet Fexofenadine 180 mg once
daily in the night for 3 months
GROUP B: Patients will receive tablet Levocetirizine 5 mg once
daily in the night for 3 months
Patients of both groups will be followed up once in 2 weeks for a
total period of 3 months. Patients of both groups will undergone Baseline investigations of
Complete Blood Count, Renal Function Test, Liver Function Test, Thyroid Function Test, Erythrocyte Sedimentation Rate, C- Reactive Protein, Absolute Eosinophil Count, Serum
Immunoglobulin E, Electrocardiography and ENT & DENTAL
opinion to rule out focal sepsis. After initial investigations each will be provided a pre-printed log
to document Urticaria Activity Score.
will be recorded in the followup visits and Urticaria Control Test
will be recorded monthly once.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age above 12 years 2) Both sexes included 3)Patients with chronic idiopathic urticaria for more than 6 weeks 4) Patients willing to give consent for study and followup 5) Patients not on any other treatment for urticaria.
排除标准
- •Patients with known causes of urticaria are excluded 2)Pregnant and lactating women 3)Patients with impaired renal function 4)Patients with all cardiac abnormalities 5)Patients not willing for regular followup.
结局指标
主要结局
Reducing itch severity and wheals number
时间窗: 6 months
次要结局
- Complete clearance of itch and wheals(6 months)
研究者
Dr Mohanraj S
Government stanley medical college and hospital, chennai