Efficacy and Safety of the combination of Paracetamol, Phenylephrine, and Chlorpheniramine Maleate for the treatment of common cold in Indian infants.

Abstract

Background: On an average, infants in India experience 6 to 8 episodes of the common cold per year. Numerous studies suggest that combination therapy, which includes antihistamines, decongestants, and analgesics, is more effective in treating the common cold compared to single-drug therapy. This study aimed to assess the efficacy and safety of the fixed-dose combination (FDC) of Paracetamol, Phenylephrine, and Chlorpheniramine maleate in Indian infants suffering from common cold. Methods: A total of 415 infants were enrolled in this study. They received the investigational product, which was an FDC containing Paracetamol (125 mg), Phenylephrine (2.5 mg), and Chlorpheniramine maleate (1 mg) per 1 ml administered in the form of oral drops. The efficacy parameter was calculated using total symptom score (TSS). The total duration of the study was 5 days with three planned visits (visit 1 on day 1, visit 2 on day 3 and visit 3 on day 5). A change in TSS from day 1 to day 5 was analysed. The safety profile was assessed by monitoring and recording adverse events throughout the study period. Results: 338 infants completed the study. The mean TSS on day 1 was 8.95, which was decreased to 4.97 on day 3 and further dropped to 0.21 on day 5. This reflects a remarkable 97.59% reduction in TSS compared to baseline (P <0.0001). Notably, by the end of the five days, 279 out of 338 patients (82.54%) were completely free from common cold symptoms. Also, no serious adverse events were reported during this active post-marketing surveillance study. Conclusion: The FDC of Paracetamol, Phenylephrine, and Chlorpheniramine maleate oral drops in infants was effective and safe for alleviating common cold symptoms in Indian infants.

Keywords: Paracetamol, Phenylephrine, Chlorpheniramine maleate, and Common Cold.