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The goal was to investigate the potential of a fixed-dose combination (FDC) of paracetamol, phenylephrine, and chlorpheniramine for addressing common cold symptoms in adults.
Paracetamol 500 mg + phenylephrine 10 mg + chlorpheniramine maleate 2 mg is effective and safe to relieve common cold symptoms in adults, with 84% of patients being symptom-free by day 3.
The goal was to investigate the potential of a fixed-dose combination (FDC) of paracetamol, phenylephrine, and chlorpheniramine for addressing common cold symptoms in adults.
A total of 420 adults aged 18-65 years were enrolled. The FDC (paracetamol 500 mg, phenylephrine 10 mg, chlorpheniramine maleate 2 mg) was administered over 5 days. Utilizing total symptom score (TSS), efficacy was assessed. On the other hand, safety was monitored through adverse events. Patients visited the clinical site on days 1, 3, and 5 for evaluation.
Of the 420 patients enrolled, 318 completed the study. The average TSS dropped from 9.016 at the first visit to 5.011 at the second, and further to 0.495 by the third visit. By the third visit, 268 volunteers (84.3%) were symptom-free. The one-way analysis of variance (ANOVA) illustrated a prominent decrease in TSS from day 1 to day 5. Moreover, the study did not record any severe adverse drug reactions; only 13 mild adverse events, such as hyperacidity and drowsiness, were observed.
For symptomatic management of common cold (upper respiratory tract infection) in adults, paracetamol + phenylephrine + chlorpheniramine maleate proved to be efficient with a favorable safety profile.
Journal of the Association of Physicians of India
Fixed-dose Combination Therapy of Paracetamol, Phenylephrine, and Chlorpheniramine Maleate for the Symptomatic Treatment of Common Cold in Indian Adults
Mayuresh Dilip Kiran et al.
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