Fixed-dose Combination Therapy of Paracetamol, Phenylephrine, and Chlorpheniramine Maleate for the Symptomatic Treatment of Common Cold in Indian Adults.

Abstract

Background: Common cold is a highly prevalent acute upper respiratory tract infection (URTI) leading to at least 4-6 episodes in adults annually. Persistent common cold infections can have a significant economic impact. Very few studies assess the efficacy of fixed-dose combination (FDC) therapies for the symptomatic treatment of common cold in Indian adults. This study assesses the efficacy and safety of FDC of paracetamol 500 mg, phenylephrine 10 mg, and chlorpheniramine maleate 2 mg for treating Indian adults with common cold symptoms. Methods: A total of 420 patients aged between 18 and 65 years were recruited for this study. Patients were evaluated for efficacy and safety using an FDC of paracetamol 500 mg, phenylephrine 10 mg, and chlorpheniramine maleate 2 mg per tablet. The study duration was 5 days, and the patients had to visit the clinical trial site for the baseline visit on the 1st day, the reevaluation visit on the 3rd day, and the conclusion visit on the 5th day. Efficacy was measured by total symptom score (TSS), and safety assessments were made using adverse events reported by patients. Results: A total of 318 out of 420 patients completed the study. On the first visit, the mean TSS was 9.016, which reduced to 5.011 and 0.495 on the second and third visits, respectively. By the third visit, 268 (84.276%) patients had no symptoms of common cold. The one-way ANOVA test showed a statistically significant reduction in TSS from the 1st to the 5th day of treatment (p < 0.0001). Additionally, there were no severe adverse drug reactions reported during the study; only 13 nonserious adverse events were reported, including hyperacidity and drowsiness. Conclusion: The FDC of paracetamol 500 mg, phenylephrine 10 mg, and chlorpheniramine maleate 2 mg was efficacious and safe for symptomatic treatment of common cold in adults.