Efficacy and Safety of a combination of Paracetamol, Chlorpheniramine maleate and Phenylephrine in the symptomatic treatment of Common Cold : Phase IV Clinical study

Abstract

Introduction and Background: Commoncold is one of the most frequently encountered disease in clinical practice. Though self-limiting, it accounts for major loss of work and school days so symptomatic therapy to treat the symptoms is often employed. A combination of Paracetamol, an antipyeretic/anti-inflammatory, Phenylephrine, a nasal decongestant and Chlorpheniramine maleate, an anti-histaminic is popular in the treatment of common cold. This Phase IV study evaluated the efficacy and safety of a combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate in treatment of common cold. Methodology –Of 216 enrolled, 187 patients completed the study. Efficacy assessment was made by reduction in TSS and four point Likert-type scales. Safety assessment was made by analyzing the adverse events during trial. Results –Reductionin TSS from 6.58 (baseline) to 3.76 (day 3) and 1.78 (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. 31 episodes of adverse events occurred and were of mild intensity. Conclusion – A combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate is safe and effective in the treatment of common cold.