Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Efficacy of Sinuclean Nebules 45 (Class 1 Medical Device) in the Treatment of Pediatric Exudative Otitis Media, Randomized, Double Blind, Comparative, Parallel
Brief Summary:
The goal of the study is to investigate if the active agent of Sinuclean Nebules is efficacious in the treatment of pediatric exudative otitis media, comparing with saline.
Sinuclean Nebules is a solution of cucurbitacins B,D,I,E (glycosylated triterpenes) 45 mcg, extracted from Ecballium Elaterium.