Efficacy and Safety of Paracetamol, Phenylephrine and Chlorpheniramine maleate FDC in Common Cold - An Indian Study - Video

The fixed-dose combination of Paracetamol, Phenylephrine, and Chlorpheniramine Maleate, was shown to be effective and safe in treating common cold symptoms in Indian adults, a recent study highlighted. These findings have been published in the November 2024 issue of the Journal of the Association of Physicians of India (JAPI).

The study was conducted across seven ENT speciality hospitals and clinics in India. 318 patients, aged 18-65 years with common cold symptoms completed the study. Participants received the FDC containing paracetamol 500 mg, phenylephrine 10 mg, and chlorpheniramine maleate 2 mg per tablet, administered three times daily for five days. Total Symptom Score (TSS) was assessed on Days 1, 3, and 5, alongside safety evaluations.

Some of the key highlights of the study are:

1) The mean TSS decreased from 9.01 to 5.011 by Day 3 and eventually to 0.495 on Day 5.

2) The mean TSS improved significantly, with a 44.42% reduction by Day 3 and 94.51% by Day 5 compared to baseline.

3) Symptom severity decreased progressively: by Day 3, only 19 patients had severe symptoms, and by Day 5, 268 patients were completely symptom-free.

4) No serious adverse events were reported; 13 patients experienced mild side effects like drowsiness or hyperacidity, which resolved on their own without any medical intervention.

Paracetamol's analgesic properties, phenylephrine's nasal decongestant effect, and chlorpheniramine's antihistaminic action contributed to rapid symptom relief. With a high percentage of patients achieving complete relief, the study supports the efficacy and safety for FDC of paracetamol, phenylephrine, and chlorpheniramine maleate as a reliable option for treating symptoms of fever, nasal congestion, rhinorrhea, and related common cold symptoms.