Common colds are highly prevalent viral infections of the nose and throat, especially in young children. It is also considered to be the most frequent cause of a physician visit, throughout the year. It mainly involves viruses like rhinovirus, corona virus, respiratory syncytial virus and para-influenza virus. In some cases, common cold can be complicated by a superadded bacterial infection such as ear infection, sinus infections, or pneumonia. The main symptoms of cold are sore throat, blocked or runny nose, sneezing and cough. The mainstay treatment of common cold thus, includes amelioration of symptoms including running nose and cough associated with fever and pain. The fixed dose combination of paracetamol, chlorpheniramine maleate, phenylephrine can provide anti-pyretic, analgesic, anti-histaminic, expectorant, and soothing action which can be used to treat cold/flu symptoms which include sinus and nasal congestion, rhinorrhea, cough, sore throat, headache, fever, minor aches and pains.

To corroborate these findings, the current randomized, double-blind, placebo-controlled trial was conducted to assess the safety and efficacy of a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults. A total of 220 patients aged above 2 years with weight between weight of 8 to 40 kg who had moderate to severe flu-like syndrome or common cold were included in this study. The patients were randomized to receive the fixed-dose combination of paracetamol (an analgesic and antipyretic); chlorphenamine (an antihistamine); and phenylephrine (a vasoconstrictor and decongestant) for 5 days. The efficacy endpoint was the sum of the scores symptoms on a scale and its tolerability profile was assessed by the occurrence of adverse events.

The outcome demonstrated that the overall symptom scores showed a significantly greater reduction from baseline till the end of the study. Moreover, the study showed mild and insignificant incidence of adverse events, among which none required discontinuation of the medication.

Thus, it can be concluded that a fixed-dose combination formulation of paracetamol, chlorphenamine and phenylephrine is a safe as well as effective therapy in the symptomatic treatment of the common cold or flu-like syndrome.

Source: Kiran M, Pawaskar L, George S, Yadav P. An open-labeled, multicentric, post-marketing surveillance (pms) to substantiate the safety and efficacy of sinarest syrup in patients of common cold. World Journal of Pharmaceutical Research. 2017;6(7):1559-1569.