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Efficacy and Safety of a Combination of Paracetamol, Chlorpheniramine Maleate and Phenylephrine in the Symptomatic Treatment of Common Cold : Phase IV Clinical Study

Affiliations

  • Medical Services, Centaur Pharmaceuticals Pvt. Ltd., India
  • Pharmacovigilance, Centaur Pharmaceuticals Pvt. Ltd., India
  • Dept of Pharmacology, Pad. Dr. D. Y. Patil Medical College, Navi Mumbai, India

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.

Keywords

Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Common Cold, Total Symptom Score (TSS), Likert-Type Symptom Severity Scale.

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References


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