Abstract
Introduction: Common cold is Self-recovering respiratory diseases which can be caused by viral infection. As till date there is no treatment for the common cold and it is self-limiting in nature, symptomatic treatment is the only option. Symptomatic treatment of common cold with a single drug is not efficacious as compared to the multiple drug combination. Combination of antipyretic (Paracetamol), nasal decongestant (Phenylephrine) and anti-histaminic agent (Chlorpheniramine Maleate) can be used for the symptomatic treatment of common cold. This post marketing surveillance study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 125mg, Phenylephrine Hydrochloride 2.5mg and Chlorpheniramine Maleate 1mg per ml in Indian patients of age 1 to 12 months.
 Methodology: Out of 200 enrolled, 164 patients completed the study. Efficacy was evaluated by total symptom score (TSS) ranging from 0 to 10 where 0 was no symptom to 10 was the maximum tolerated symptoms. TSS was further extrapolated to four-point-Likert-type-symptom-severity-scale. Safety assessment was done by evaluation of adverse events reported by the patient.
 Results: TSS was reduced from 5.91 on day 1 to 3.57 on day 3 and 1.47 on day 5. At day 3 and day 5 the percentage reduction in the TSS as compared to the baseline was 39.48 and 75.05 respectively. During the study only 8 episodes of ADRs were reported including sedation and drowsiness.
 Conclusion: Combination of Paracetamol, Phenylephrine and Chlorpheniramine Maleate was found to be efficacious and safe for the treatment of common cold and allergic rhinitis.
 Keywords: Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Common Cold, Allergic Rhinitis.
Highlights
Common cold is Self-recovering respiratory diseases which can be caused by viral infection
Patients hypersensitive to the investigational product, patients having hypertension, the guardian of the patient who could not adhered to the protocol including mentally ill or with psychological problems were excluded from the study
Investigational product: The investigational product used for the study was the fixed dose combination of Paracetamol 125 mg, Phenylephrine Hydrochloride 2.5 mg and Chlorpheniramine Maleate 1 mg per ml
Summary
Common cold is Self-recovering respiratory diseases which can be caused by viral infection. Combination of antipyretic (Paracetamol), nasal decongestant (Phenylephrine) and anti-histaminic agent (Chlorpheniramine Maleate) can be used for the symptomatic treatment of common cold. Conclusion: Combination of Paracetamol, Phenylephrine and Chlorpheniramine Maleate was found to be efficacious and safe for the treatment of common cold and allergic rhinitis. Headache, body ache, running nose, blocked nose and sneezing are common symptoms of a common cold.(2) Allergic Rhinitis is a symptomatic nasal condition triggered by IgEmediated hypersensitivity reactions to allergens. It is characterised by four cardinal symptoms including watery rhinorrhoea, nasal congestion, nasal itching, and sneezing. While allergic rhinitis is not as frequent as common cold, it still has a prevalence of 10-30% in adults and nearly 40% in children in the United States.(3)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
