Latest Study Finds Fixed-Dose Combination of Paracetamol, Phenylephrine, and Chlorpheniramine Maleate Effective and Safe for Common Cold in Indian Adults
The fixed-dose combination (FDC) of Paracetamol 500 mg, Phenylephrine 10 mg, and Chlorpheniramine maleate 2 mg was effective and safe for the symptomatic treatment of common cold in adults, according to a recent study published in the Journal of The Association of Physicians of India.
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.
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.
References:
- 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.
- Worrall G. Common cold. Can Fam Physician. 2011 Nov;57(11):1289-90. PMID: 22084460; PMCID: PMC3215607.
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