Efficacy And Safety For A Combination Of Paracetamol, Chlorpheniramine Maleate And Phenylephrine In The Symptomatic Treatment Of Common Cold And Allergic Rhinitis In Infants: Phase Iv Clinical Study.
Journal Title: International Journal of Medical Science and Innovative Research (IJMSIR) - Year 2019, Vol 4, Issue 1
Abstract
Common cold and allergic rhinitis are most common diseases in Indian clinical practises. Both are self-limiting but it accounts for loss of school and work days. Symptomatic therapy is often used to treat the symptoms. Combination of anti-histaminic, anti-inflammatory/ analgesic/ antipyretic and nasal decongestant is popular in the treatment of common cold and allergic rhinitis. This Phase IV study was conducted to evaluate the efficacy and safety for the combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate for the treatment of common cold and allergic rhinitis Of total 200 enrolled patients, 169 patients completed the study. Efficacy assessment was done by reduction in Total Symptom Score (TSS) extrapolated to four point Likert-type scales. Safety assessment was done by analysing the adverse events through the study. At visit 1 (baseline) mean TSS was 6.165 which was reduced to 2.822 at visit 2 (day 3) and further reduced to 0.834 at visit 3 (day 5). At visit 2 and visit 3 there was reduction of 54.22% and 86.46% respectively in TSS as compared to baseline. Adverse events were observed in only 2.366% of total population through the clinical study. Combination of Paracetamol, Phenylephrine and Chlorpheniramine maleate is safe and effective for the treatment of common cold and allergic rhinitis.
Authors and Affiliations
Dr. Mayuresh Kiran
Keywords
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