Abstract

AN OPEN-LABELED, MULTICENTRIC, POST-MARKETING SURVEILLANCE (PMS) TO SUBSTANTIATE THE SAFETY AND EFFICACY OF SINAREST SYRUP IN PATIENTS OF COMMON COLD.

Dr. Kiran M., Lalait Pawaskar, Shruthi George and Dr. Pramila Yadav

Abstract

Background: The common cold and other viral airway infections are highly prevalent in the population, and their treatment often requires the use of medications for symptomatic relief. Paracetamol is as an analgesic and antipyretic; chlorphenamine is an antihistamine; and phenylephrine, a vasoconstrictor and decongestant. This randomized, double-blind, placebo-controlled trial sought to evaluate 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. Methods: 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. After clinical examination, patients were randomly assigned to receive the fixed-dose combination for 5 days. The efficacy endpoint was the sum of the scores symptoms on a scale. To evaluate safety, the occurrence of adverse events was measured. Results: Mean age was 10.82 (± 6.48) years in the treatment group. There were 115 females and 95 males in the treatment group. The overall symptom scores revealed a significantly greater reduction from baseline till the end of the study. (p = 0.015). the adverse events were mild to moderate and none required discontinuation of the study medication. Conclusion: A fixed-dose combination syrup formulation of paracetamol, chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults.

Keywords: Paracetamol, chlorphenamine, phenylephrine common cold.