Efficacy and Safety for the Fixed-Dose Combination of Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Sodium Citrate, and Menthol in Suspension for Common Cold in Pediatric Patients
Abstract
Abstract
Background: Acute upper respiratory tract infection (URTI), frequently referred to as common cold, is a self-limiting disease of the upper respiratory tract (URT). Children are more prone to viral infection because their immune systems are underdeveloped. Studies showed that a combination of analgesics, antihistamines, and decongestants is more effective than monotherapy. This clinical trial evaluated the efficacy and safety of the fixed-dose combination (FDC) of Paracetamol, Phenylephrine, Chlorpheniramine maleate,
Sodium citrate, and Menthol in children suffering from common cold.
Methods: This was an open-label, non-randomized, non-comparative active post-marketing surveillance study. Children suffering from common cold between 2 and 12 years of age were included. The duration of the study was five days. The efficacy assessment parameter was the total symptom score (TSS). The patients visited the clinical trial site on the first day (baseline visit), the third day (re-evaluation visit), and the fifth day (conclusion visit).
Results: A total of 311 patients completed this study. The mean TSS on day 1 was 9.06 which was reduced to 4.79 on day 3 and further reduced to 0.19 on day 5. On day 3 and day 5, the percentage reduction in the mean TSS as compared to baseline was 47.33% and 95.56% respectively. The one-way ANOVA test results revealed that there was a statistically significant decrease (p< 0.0001) in TSS from the first to the fifth day. Additionally, there were no severe adverse drug reactions reported during the study, and no adverse events led to the premature discontinuation of the study. Only 20 mild adverse events were reported.
Conclusion: FDC of Paracetamol 250 mg, Phenylephrine 5 mg, Chlorpheniramine maleate 2 mg, Sodium citrate 60 mg, and Menthol 1 mg per 5 ml was efficacious and safe for the symptomatic treatment of common cold in children.
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