A randomised control trial on the effectiveness of antifungal and steroid nasal douching in allergic fungal rhinosinusinitis a clinical, radiological and biochemical corelation

Proven studies showing effectiveness of combined approach medical management with systemic steroid, systemic antifungal and steroid nasal douching in pre-surgical patients are not present till date. This study aims to find out the efficacy of antifungal  and steroid nasal douching in AFRS patients presurgically. It also aims to correlate the effectiveness of this therapy with clinico-radiological and biochemical parameters. No randomized control trials are also not available on this aspect. In this study, Tab prednisolone 1 mg/kg for 7 days, 0.8 mg/kg for 7 days, 0.6 mg/kg for 7 days, 0.4 mg/kg for 7 days followed by 0.2 mg/kg for 14 days given (total duration 6 weeks). Patient monitored every 2 weekly with body weight/lft to see adverse effect of steroid therapy and serum cortisol levels on day 7 and 21. Itraconazole 400mg PO BD on day 1 followed by 200 mg/day for 6 weeks  will be given. Pre therapy Liver function test (LFT) will be done and every 2 weekly LFT will be repeated during Itraconazole treatment course. The treatment will be hold in patients with deranged liver function test till the value become normalised. Budesonide nasal douching ( 1mg dose of budesonide suspension in 240 ml normal saline – 60 ml of this solution in each nostril BD for 6 weeks). After 6weeks of therapy, clinical evaluation will be done on the basis of SNOT22 scoring system. Endoscopic evaluation will be done with Meltzer Clinical scoring system. This endoscopic evaluations will be done at 6th weeks from starting of the treatment. All the clinical, biochemical, and radiological parameter will be repeated and compared. Blood samples will be sent for serum total IgE, baseline Aspergillus specific IgE to the Department of Pulmonary Medicine in serum vial.Serum interleukin 5 levels will be measured pre and post treatment. For radiological study, LundMackay system and 20points scoring system CT Scan will be used.Clinical, biochemical parameter will be quantified and compared and radiological parameter pre and post therapy will be compared at 6 weeks to assess the effectiveness of therapy. The patients will be kept on follow-up till 3 months and persistence of disease after 3 months will be considered for surgery.