A single-blind randomized controlled clinical study comparing the efficacy, tolerability and safety of levocetrizine and olopatadine in chronic urticaria
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Urticaria Severity Score(UAS)
研究概览
简要总结
Patients of chronic urticaria having symptoms of itching, wheals > 6 weeks were screened according to inclusion/exclusion criteria were randomly allocated oral trial medications (either olopatadine tablets 5 mg or levocetrizine tablets 5 mg) continously for 4 weeks and then on as and when needed basis for another 5 weeks. The effects of the above mentioned antihistamines were recorded with respect to decrease/increase in symtoms. Scoring systems used were Urticaria activity score (UAS), Urticaria total severity score (TSS), Patients’ and Physicians’ global assessment of disease activity improvement (5 point Likert scale). The scores were recorded at 1, 2, 3, 4, 5, 9 weeks after randomisation.
Safety data were collected with respect to baseline and 4th follow-up laboratory values of routine haemogram, LFT, serum urea, creatinine, blood glucose. Also adverse effects were recorded.
Our study hypothesis was that levocetrizine and olopatadine were equally efficacious in the treatment of patients with chronic urticaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age above 18 years
- •Patients of either sex
- •Patients suffering from urticaria for more than 6 weeks.
排除标准
- •1Pregnant or nursing women 2End stage renal disease 3Patients having immunosuppression due to drug or disease 4History of alcohol or substance abuse 5Subjects working in night-shifts or are likely to change the usual sleep/wake cycle.
- •6Patients driving automobiles.
- •7Participation in any other clinical trial within past 3 months 8Patients unwilling to provide written informed consent or unlikely to comply with the trial protocol 9Any other condition, which in the opinion of the investigators, is not conducive to inclusion of the subject in the trial.
结局指标
主要结局
Urticaria Severity Score(UAS)
时间窗: 4,9 weeks after randomisation
Total Symptom Severity Score (TSS),
时间窗: 4,9 weeks after randomisation
Patients and Physicians global assessment of disease activity improvement (5 point Likert scale)
时间窗: 4,9 weeks after randomisation
次要结局
- LFT(Routine haemogram)