Comparative study of efficacy and safety of cetrizine and bilastine in patients of chronic spontaneous urticaria: open label, randomised, parallel group study.

Dr Vishakha Sinha0 个研究点目标入组 63 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•1. Subjects aged 18-65 years, literate of either gender who are willing to participate in the study by signing a written informed consent.
•2.Subjects giving history of urticarial wheal for at least 3 days a week for 6 consecutive weeks with no obvious cause prior to inclusion in study.
•3.Subjects having a mean total symptom score more than equal to 3 at screening. This includes 1-5 number of wheal score more than equal to 1 at least a moderate severity of pruritus score of 2.
•4.Those who understand and agree to adhere to the dosing visit schedules assess and record their symptoms severity score, concomitant medications and adverse events and other details accurately and consistently in a daily dairy.
•5.Patients with normal ECG

•1.History of asthma or any other disease requiring chronic use of inhaled or systemic corticosteroids.
•2.History of allergies to study medication or unable to tolerate antihistamines.
•3.Subjects with acute urticaria or with other known aetiology.
•4.Pregnant women and nursing mothers.
•5.Subjects with significant hematopoietic, cardiovascular, hepatic and renal disorder.
•6.History suggestive of neurologic, psychiatric or autoimmune diseases.
•7.Patients suffering from any other systemic illness.
•8.Patients on concomitant drug therapy like antihistamines, corticosteroids (topical and oral) and CNS depressants like sedatives.

发起方

Dr Vishakha Sinha