International Journal of Basic & Clinical Pharmacology | July-August 2024 | Vol 13 | Issue 4 Page 469 International Journal of Basic & Clinical Pharmacology Kiran MD et al. Int J Basic Clin Pharmacol. 2024 Jul;13(4):469-474 http://www.ijbcp.com pISSN 2319-2003 | eISSN 2279-0780 Original Research Article Efficacy and safety of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in Indian paediatric patients with common cold: an active post-marketing surveillance study Mayuresh D. Kiran 1 , Lalit J. Pawaskar 2 , Pramita D. Waghambare 2 *, Aakansha V. Singh 3 INTRODUCTION Common cold is an acute, self-limiting viral infection affecting the upper respiratory tract, encompassing the nose, sinuses, pharynx, and larynx. 1 Over 200 viruses can incite a cold, with rhinoviruses being the most prevalent. It is clinically represented by the symptoms of acute respiratory viral infections (ARVI) such as rhinorrhoea, nasal obstruction, nasal congestion, runny nose, and sneezing. 2-4 Adults typically get 2-3 upper respiratory tract infections (URTIs) per year, whereas children have 6-7 episodes per year, thus it is an important problem in paediatric practice. 5 Symptoms of the common cold in children typically reach peak intensity shortly after the onset of illness. Symptom duration is approximately 7-10 days but may range from 2-14 days. 6 The severity and type DOI: https://dx.doi.org/10.18203/2319-2003.ijbcp20241594 1 Medical Services and Pharmacovigilance, Centaur Pharmaceuticals Pvt Ltd., Mumbai, Maharashtra, India 2 Pharmacovigilance and Biomedical Research, Centaur Pharmaceuticals Pvt Ltd., Mumbai, Maharashtra, India 3 Medical Services, Centaur Pharmaceuticals Pvt Ltd., Mumbai, Maharashtra, India Received: 13 May 2024 Revised: 24 May 2024 Accepted: 29 May 2024 *Correspondence: Pramita D. Waghambare, Email: pramita@centaurlab.com Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: The common cold, mainly caused by viruses, brings discomfort to children with symptoms like sneezing, congestion, runny nose, and sore throat. As no specific antiviral treatments are available to relieve common cold symptoms, it is typically managed using decongestants, antihistamines, and antipyretics. This study aims to assess the safety and efficacy of a fixed-dose combination (FDC) of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in children aged 2 to 12 years with common cold. Methods: This non-randomized, open-label, non-comparative, active post-marketing surveillance (PMS) study was conducted across multiple centres in India, involving 417 patients. The study assessed efficacy using the total symptom score (TSS) scale over 5 days with visits on days 1, 3, and 5. Safety was evaluated based on adverse events reported by patients on days 3 and 5 of the trial. Results: Initially, 417 patients were enrolled in the active PMS, of which 309 completed the study. The mean TSS showed a notable decrease from 8.95 at visit 1 to 0.19 at visit 3, depicting a significant reduction i.e., 97.90% as compared to baseline. At visit 1, most patients (95.79%) exhibited severe symptoms, whereas by visit 3, 83.82% were symptom-free, with only 16.18% experiencing mild symptoms. Conclusions: This active PMS study examined the safety and efficacy of an FDC of paracetamol, phenylephrine, chlorpheniramine maleate and sodium citrate in treating common cold in children in India. The findings indicate a significant reduction in symptoms, with many patients becoming symptom-free by the third visit, demonstrating its efficacy and safety. Keywords: Paracetamol, Phenylephrine, Chlorpheniramine maleate, Sodium citrate, Common cold