A Prospective, Interventional, Multicentre, Post-marketing Clinical Study of a fixed-dose combination of Paracetamol (125 mg), Phenylephrine HCL (5 mg), Chlorpheniramine Maleate (1 mg) and Sodium Citrate (60 mg/5 mL) for the Treatment of Common Cold and Flu Syndrome in Children

ABSTRACT

Background: Common cold is an acute, self-limiting viral infection of the upper respiratory tract involving the nose, sinuses, pharynx, and larynx. According to various studies, the combination of analgesics, decongestants, and antihistamines provides better relief for multiple symptoms in the common cold. Fixed dose combination of Paracetamol as an analgesic, anti-inflammatory, and antipyretic, Chlorpheniramine maleate, an anti-histaminic, and Phenylephrine as a nasal decongestant is primarily used in the treatment of the common cold. Hence the present post-marketing surveillance study was planned to find any unwanted adverse effects and efficacy of commercially available combination in treating the common cold in children. Methodology: The prospective, single-arm, multicenter, post-marketing clinical study included 224 children from four different study sites, of which 204 completed the study. Subjects were given this fixed dose combination for three days and then monitored for the next six days. During the study, the efficacy was evaluated using VAS score changes from the beginning to the end of the treatment. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) was assessed. The product's safety was also evaluated using blood biomarkers such as Hemoglobin, Platelet count, SGOT, SGPT, and creatinine level. Results: The reduction in symptomatic score of common cold and flu syndrome was observed after 3rd followup visit [(0.384±0.168 (visit 1) to 0.001±0.009 (Visit 3), (p<0.001)]. No intervention-related or serious adverse events (SAE) were observed in the study or follow-up period. The study found no major changes in the levels of haemoglobin, platelets, SGOT, SGPT, and creatinine. Conclusions: Fixed-dose combination of Paracetamol (125 mg), Phenylephrine HCL (5 mg), Chlorpheniramine Maleate (1 mg) and Sodium Citrate (60 mg/5 mL) is safe and effective in treating children's common cold and flu syndrome.