Abstract
Introduction: Common cold is frequently occurring medical condition in developing countries like India. Common cold is self-limiting in nature so symptomatic treatment is always suggested. This study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet for the treatment of common cold.
 Methodology: Total 180 patients were enrolled out of which 159 completed the study. Efficacy assessment was done by decrease in total symptom score (TSS) of common cold at day 3 and 5 as compared to the baseline (day 1). Safety assessment was made by analyzing the reported adverse events through the study.
 Results: Mean TSS at baseline was 6.62 which was decreased to 3.55 at day 3 and was further decreased to 0.68 at day 5. Majority of patients had complete relief from the symptoms of common cold and nearly all the patients had >50 % reduction in TSS. Also no unexpected or serious adverse event was found to be reported in the study duration of 5 days.
 Conclusion: Fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet was found to be efficacious and safe for the symptomatic treatment of common cold in Indian patients.
 Keywords: Common cold, Paracetamol, Chlorpheniramine Maleate and Phenylephrine
Highlights
Common cold is frequently occurring medical condition in developing countries like India
Common cold or acute coryza is majorly known as acute upper respiratory disease which affects people of all ages including adults and children
Most commonly it is considered to be caused by Rhinovirus and other viruses can cause the same including but not limited to respiratory syncytial virus, adenovirus, coronavirus, parainfluenza and influenza viruses.[1]. As common cold is a self-limiting disease and only symptomatic treatment is considered to be required for the treatment
Summary
Common cold is frequently occurring medical condition in developing countries like India. This study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet for the treatment of common cold. As per the Cochrane review, Picon PD et al, Eccles R et al and guidelines of DPHHS the combination of analgesics, decongestants and antihistamines can provides significant benefits for multi symptom relief in common cold.[2,3] So this study was conducted to test the efficacy and safety for the treatment of common cold in Indian patients for the fixed dose combination of Paracetamol 500 mg, Phenylephrine 10 mg and Chlorpheniramine Maleate 2 mg per tablet
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