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World Journal of Pharmaceutical
and Medical Research

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
ISSN 2455-3301
IMPACT FACTOR: 4.639

ICV : 78.6

Abstract

SAFETY AND EFFICACY FOR THE COMBINATION OF CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE IN THE SYMPTOMATIC TREATMENT OF ALLERGIC RHINITIS IN PAEDIATRIC POPULATION: PHASE IV CLINICAL TRIAL

Dr. Mayuresh Kiran* and Lalit Pawaskar

ABSTRACT

Introduction: Allergic rhinitis, a trivial illness causing significant degree of morbidity can alter the social life of patients affecting school performance and has a prevalence of up to 40% in the pediatric population. FDC of Chlorpheniramine Maleate, an anti-histaminic and Phenylephrine, a nasal decongestant is much celebrated in the treatment of Allergic Rhinitis in Children. Methodology: Of 193 registered, 172 patients completed the study. Safety assessment was made by inspecting the adverse events during trial. Efficacy assessment was made by decrease in TSS and extrapolating to four point Likert type scales. Results: Reduction in mean TSS was from 6.19 at baseline to 3.09 at day 3 and 0.75 at day 5. One point reduction in Likert-type symptom scale from Moderate to Mild took just 3 days and was further reduced to less than mild at day 5. Nearly all the patients had >50% reduction in symptom score at day 3 and day 5. At day 3 and day 5 there was reduction of 49.95 % and 87.88 % respectively in mean TSS as compared to baseline. 35 episodes of adverse events occurred and were of mild intensity including sedation and drowsiness being dominantly seen. Conclusion: A combination of Chlorpheniramine Maleate and Phenylephrine was found to be safe as well as effective in the treatment of Allergic Rhinitis in paediatric population.

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