Efficacy and Safety of a Fixed Dose Combination of Paracetamol, Chlorpheniramine Maleate, Phenylephrine and Caffeine in Treatment of Common Cold: A Phase IV, Open-Labelled, Multi-Centric Study

Common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. It also leads to reduction in subjective alertness and impaired psychomotor functioning. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyeretic, Chlorpheniramine maleate, an anti-histaminic, and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Addition of caffeine enhances alertness and psychomotor functioning. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold. Methods: This was a phase IV, open-labelled, multicentric study in 262 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study. Results: There was reduction in mean TSS from 7.67 (day 1) to 3.78 (day 3) and 0.66 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 59.16 % patients had complete relief from the symptoms at the end of study. Out of 262 patients, 46 i.e. 17.56% experienced adverse event. Sedation and drowsiness (12.21%) was the most common adverse event seen in patients. Conclusion: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, Phenylephrine and Caffeine is safe and effective in the treatment of common cold.