To compare efficacy, safety and cost-effectiveness of rupatadine and olopatadine in patients of chronic idiopathic urticaria: a randomized, double-blind, comparative, parallel group study.

Indira Gandhi Government Medical college0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Inclusion Criteria
•1) Those who were willing to participate in the study and comply with its procedures by signing a written informed consent.
•2) Patients from Out-Patient Department (OPD) of dermatology between age group of 18 to 65 years of either sex.
•3) History of urticarial wheal and/or angioedema for at least 3 days a week for 6 consecutive weeks with no obvious cause prior to inclusion in study.
•4) Mean total symptom score (24 hour reflective) >= 3 at screening. This includes 1-5 number of wheals (score >= 1); at least a moderate severity of pruritus (score>=2).
•5) Patients who were on any antihistamines except rupatidine and olopatadine were also included in the trail only after giving washout period of 7 days, irrespective of doses of the previous drugs.
•6) Those who understood and agreed to adhere to the dosing and visit schedules, and agree to assess and record their symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.

•Exclusion criteria
•1) History of asthma or any other disease requiring chronic use of inhaled or systemic corticosteroids.
•2) Subjects with acute spontaneous urticaria or all physical and other subtypes of urticaria like aquagenic, cholinergic, contact and exercise induced urticaria
•3) Had been unresponsive to antihistamine treatment in the past.
•4) History of allergies to study medication or unable to tolerate antihistamines.
•5) Use of study drug in the last 7 days prior to baseline and not willing to take washout period.
•6) Pregnant female, nursing mothers.
•7) Subjects with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease

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