Efficacy and safety of a fixed dose combination of paracetamol, chlorpheniramine maleate and phenylephrine in treatment of common cold: a phase IV, open-labelled, multi-centric study

Abstract

Background: Acute coryza or common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. A triple combination of analgesics, decongestants and antihistamines provides better relief for multiple symptoms in common cold and allergic rhinitis according to various studies. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyretic, Chlorpheniramine maleate, an anti-histaminic and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold.Methods: This was a phase IV, open-labelled, multicentric study in 159 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study.Results: There was reduction in mean TSS from 6.62 (day 1) to 3.56 (day 3) and 0.69 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 58.49% patients had complete relief from the symptoms at the end of study. Out of 159 patients, 26 i.e. 16.36% experienced adverse events. Sedation and drowsiness (6.29%) were the most common adverse event seen in patients.Conclusions: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, and Phenylephrine is safe and effective in the treatment of common cold.

Efficacy and Safety for the Combination of Paracetamol, Phenylephrine and Chlorpheniramine Maleate in Indian Paediatric Patients of Common Cold and Allergic Rhinitis- Post-Marketing Surveillance Study

“…(3) Common cold is a self-limiting disease so the treatment should focus on symptomatic relief as there is no effective antivirals for the treatment of common cold. (4) Optimum symptomatic relief from the single drug therapy is not possible which is why the combination therapy is always preferred by the healthcare professionals for the symptomatic treatment. As per the Cochrane review, guidelines of DPHHS, Picon PD et al and Eccles R et al the combination of antihistamines, decongestants and analgesics can provide significant symptomatic relief in common cold.…”

Post-Marketing Surveillance Study to Substantiate the Efficacy and Safety for the Combination of Paracetamol, Phenylephrine, Chlorpheniramine Maleate, Sodium Citrate and Menthol in Indian Patients of Common Cold

“…A Total of 16.57 % patients experienced adverse events majority being sedation and drowsiness which could be due to Chlorpheniramine maleate. The study concluded that the combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate was efficacious and safe for the treatment of common cold and allergic rhinitis [12] .…”

Post-Marketing Surveillance Study to Substantiate the Efficacy and Safety for the Combination of Paracetamol, Phenylephrine and Chlorpheniramine Maleate in Indian Patients of Common Cold

“…(3) The drawback of the research was that a common cold is a self-limiting disease and can be naturally cured in 10 days as per the literature. (7,8) So to minimize the same, the clinical trial duration was kept 5 days so the maximum efficacy results presented in this paper were considered to be because of the investigational product.…”