Latest Study Finds Fixed-Dose Combination of Paracetamol, Phenylephrine, and Chlorpheniramine Maleate Effective and Safe for Common Cold in Indian Adults

Common cold is an acute and self-limiting upper respiratory tract infection, causing symptoms like fever, nasal congestion, sore throat, and coughing. It generally affects adults 4-6 times annually, with symptoms lasting 5-7 days, and rhinovirus is the most common cause. Despite the viral nature of the infection, antibiotics are often over-prescribed, contributing to antibiotic resistance. Paracetamol, Phenylephrine, and Chlorpheniramine maleate are commonly used to treat symptoms, but limited research exists on the efficacy and safety of their FDC.

This led the researchers to conduct a study evaluating the efficacy and safety of FDC of Paracetamol 500 mg, Phenylephrine 10 mg, and Chlorpheniramine maleate 2 mg for treating common cold symptoms in Indian adults.

Researchers enrolled 420 patients, aged 18 to 65 years, to assess the efficacy and safety of the FDC of the investigational product. Of these, 318 patients completed the study. The FDC was administered as one tablet orally three times, every 8-hourly, for 5 days. The patients visited the clinical trial site on Day 1 (baseline), Day 3 (re-evaluation), and Day 5 (conclusion) for evaluation of efficacy and safety. The efficacy was measured using the total symptom score (TSS), while safety was evaluated based on adverse events reported by the patients.

Key findings from the study, are detailed below:

Efficacy assessment:

• The Total Symptom Score (TSS) decreased significantly from 9.016 at baseline to 5.011 on the second visit and 0.495 on the third, reflecting a 44.42% reduction by the second visit and 94.51% by the third visit over five days.
• At baseline, 315 patients presented with severe symptoms, while three exhibited moderate symptoms. By the third visit, none had severe symptoms, two had moderate, 48 had mild, and 268 (84.276%) were symptom-free, showing the treatment's efficacy over five days. (Fig. 1A and B)

Fig. 1A and B: (A) Mean TSS on visit first, second, and third; (B) Percentage reduction in the mean TSS on visit second and third compared to baseline

Safety assessment:

• During the study, only 13 patients experienced mild adverse effects. Hyperacidity was reported by four patients, and drowsiness by nine patients likely due to the presence of Paracetamol and Chlorpheniramine maleate in the treatment. All adverse events were mild, non-serious, and did not require medical intervention.

The researchers concluded that the study provides substantial evidence supporting the efficacy and safety of the FDC containing Paracetamol 500 mg, Phenylephrine 10 mg, and Chlorpheniramine maleate 2 mg for managing common cold symptoms in Indian adults. The findings demonstrated a significant reduction in TSS and a high percentage of patients achieving complete relief.

They recommended further randomised clinical trials with a larger sample size to evaluate the treatment's efficacy and potential adverse effects in Indian adults suffering from the common cold.

1. Kiran MD, Waghambare PD, Pawaskar L, Singh A. Fixed-dose Combination Therapy of Paracetamol, Phenylephrine, and Chlorpheniramine Maleate for the Symptomatic Treatment of Common Cold in Indian Adults. J Assoc Physicians India. 2024 Nov;72(11):45-48. doi: 10.59556/japi.72.0729. PMID: 39563116.
2. Worrall G. Common cold. Can Fam Physician. 2011 Nov;57(11):1289-90. PMID: 22084460; PMCID: PMC3215607.