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.

Dr Mayuresh
Dilip Kiran, (MD Pharmacology) and lead author of the study
said, “The results of our study confirm the efficacy and safety of the
fixed-dose combination of Paracetamol, Phenylephrine, and Chlorpheniramine
maleate in providing rapid relief from common cold symptoms. With over 84% of
patients achieving complete symptom resolution by the fifth day, this
combination therapy offers a reliable and well-tolerated option for managing a
condition that significantly impacts daily productivity and quality of life”.

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.