Common cold and viral respiratory tract infections are very predominant among the adult population, and it often requires taking of certain medications for symptomatic relief. Paracetamol is an analgesic and antipyretic medicine. Chlorphenamine is an antihistamine whereas phenylephrine is a vasoconstrictor and decongestant.

The objective of this randomized, placebo-controlled and double-blind trial is to assess the efficacy and safety of a fixed-dose combination of paracetamol, phenylephrine and chlorphenamine in the symptomatic treatment of the common cold and flu-like symptoms in adults.

In this trial, 146 individuals who were aged between 18 to 60 years and having moderate to severe flu-like symptoms or common cold were enrolled. After the preliminary clinical examination and laboratory investigations, individuals were assigned randomly to receive the fixed-dose combination (73 individuals) or placebo (73 individuals), 5 capsules every day for 48 to 72 hours. The primary efficacy endpoint was the total of the scores of 10 symptoms on a 4-point Likert-type scale. A total of 55 women and 18 men were included in the placebo group, and 46 women and 27 men were included in the treatment group.

The results of the trial showed that the overall symptom scores had a significant greater reduction in the treatment group as compared to the placebo group (p = 0.015). Evaluation during the first 13 dose intervals (± 66 hours of treatment) revealed a greater reduction of symptom scores in the treatment group than in the placebo group (p < 0.05). The number of adverse events were almost similar in both groups.

Thus, the study concluded that a fixed-dose combination of paracetamol, phenylephrine and chlorphenamine was safe and more effective in the symptomatic treatment of the common cold or flu-like symptoms in adults.

Source: Picon PD, Costa MB, da Veiga Picon R, Fendt LC, Suksteris ML, Saccilotto IC, Dornelles AD, Schmidt LF. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC Infect Dis. 2013 Nov 22;13:556.