Efficacy and Safety of Paracetamol, Phenylephrine and Chlorpheniramine maleate FDC in Common Cold - An Indian Study - Video
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Overview
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.
*Total Symptom Score
Reference:
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.
Speakers
Dr. Bhumika Maikhuri
BDS, MDS
Dr Bhumika Maikhuri is an orthodontist with 2 years of clinical experience. She is also working as a medical writer and anchor at Medical Dialogues. She has completed her BDS from Dr D.Y. Patil Medical College and Hospital and MDS from Kalinga Institute of Dental Sciences. She has a few publications and patents to her credit. Her diverse background in clinical dentistry and academic research uniquely positions her to contribute meaningfully to our team.