Safety and Efficacy of a topical combination of Ofloxacin, Clotrimazole, Beclomethasone and Lignocaine for management of Mixed Ear Infections : Phase IV Study
Journal Title: International Journal of Medical Science and Innovative Research (IJMSIR) - Year 2017, Vol 2, Issue 3
Abstract
Introduction: Otitis is a general term used for inflammation of the ear which is commonly caused due to bacteria and fungi. It is subdivided into 3 types which are named as otitis externa, otitis media and otitis interna. Out of which otitis media with perforated ear and otitis externa can be topically treated by the combination of Ofloxacin, Clotrimazole, Beclomethasone Dipropionate and Lignocaine. Methodology: Total 189 patients were enrolled out of which 174 patients completed the study. Efficacy assessment was made by reduction in Visual Analogue Scale (VAS) Score of ear pain, ear discharge and ear itching related to Otitis media and Otitis Externa. Safety assessment was made by analysing the adverse events through the study. Results: Reduction in mean VAS score was done from 4.12 (baseline) to 2.293 (day 3) to 0.54 (day 5) of ear pain, from 4.011 (baseline) to 1.931 (day 3) to 0.563 (day 5) of ear discharge and from 2.896 (baseline) to 1.31 (day 3) to 0.241 (day 5) of ear itching. Nearly all the patients had >50% reduction in their VAS score at all visits in all the parameters except in visit 2 in ear pain where reduction was 44.34 %. Majority of patients had complete relief from the symptoms at visit 3. 17 episodes of adverse events were occurred and all of them were of mild intensity. Conclusion: A combination of Ofloxacin, Clotrimazole, Beclomethasone Dipropionate and Lignocaine is safe and effective in the treatment of Otitis media and Otitis externa.
Authors and Affiliations
Dr. Mayuresh Kiran
Keywords
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