Title: Efficacy and Safety of a Combination of Paracetamol, Levocetirizine and Phenylephrine in the symptomatic treatment of Common Cold and Allergic Rhinitis in Children: Phase IV Clinical Study
Authors: Dr Mayuresh Kiran, Shruthi George, Lalit Pawaskar
DOI: https://dx.doi.org/10.18535/jmscr/v5i3.190
Abstract
Introduction –It is the most frequently encountered self-limiting viral respiratory diseases. Common cold has a greater adverse impact on, absenteeism, productivity and daily life so symptomatic therapy to treat the symptoms is often employed. A FDC of Paracetamol, an antipyretic, Phenylephrine, a nasal decongestant and Levocetirizine, an anti-histaminic is popular in the treatment of Common Cold and Allergic Rhinitis in adults. This Phase IV study appraised the efficacy and safety of a combination of Paracetamol, Phenylephrine and Levocetirizine in treatment of common cold.
Methodology–Of 185 enrolled, 156 patients completed the study. Safety assessment was made by inspecting the adverse events during trial. Efficacy assessment was made by decrementing in TSS and four point Likert-type scales.
Results– Reduction in TSS from 5.05 (baseline) to 2.58 (day 3) and 0.61(day 5). One point reduction in Likert-type symptom scale from Moderate to Mild took just 3 days. Nearly all the patients had >50% reduction in symptom score at all visit and majority of patients had complete relief from the symptom. 20 episodes of adverse events occurred and were of mild intensity.
Conclusion – A fixed-dose combination of Paracetamol, Phenylephrine and Levocetirizine is safe and effective in the treatment of Common Cold and Allergic Rhinitis in children.
Keywords – Paracetamol, Levocetirizine, Phenylephrine, Common Cold, Allergic Rhinitis
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