Efficacy and safety for a combination of paracetamol, chlorpheniramine maleate, phenylephrine, sodium citrate and menthol in the symptomatic treatment of common cold and allergic rhinitis: phase iv clinical study

Introduction and Background: Common cold and allergic rhinitis are most frequently encountered diseases in clinical practices. It is self-limiting but it accounts for major loss of school or work days so symptomatic treatment is often employed. A combination of Paracetamol as an anti-inflammatory and antipyeretic, Chlorpheniramine maleate, an anti-histaminic and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. The study medication also contains Sodium citrate which liquefies mucus and helps expectoration and menthol has cooling and soothing effect. This Phase IV study was conducted for evaluating the efficacy and safety of a combination of Paracetamol, Phenylephrine, Chlorpheniramine maleate, Sodium Citrate and Menthol in the treatment of common cold.
Methodology: Out of total 216 patients, 162 completed the study. Efficacy assessment was made by analysing the reduction in TSS and four point Likert-type scales. Safety assessment was made by analysing the adverse events during trial.
Results: Reduction in TSS from 6.10 (baseline) to 2.87 (day 3) and 0.48 (day 5). One point reduction in Likert-type symptom scale from Moderate to Mild took in just 3 days. Most of the patients had >50% reduction in total symptom score at all visits and 67 % patients had complete relief from the symptoms at the end of clinical trial. 50 episodes of adverse events occurred and were of mild intensity.
Conclusion: A combination of Chlorpheniramine maleate, Paracetamol, Phenylephrine, Sodium Citrate and Menthol is safe and effective in the treatment of common cold and allergic rhinitis.