Ulcerative Colitis Chronic Clinical Trial
Official title:
Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
My study aims to directly compare the efficacy and safety of Budesonide MMX versus Prednisolone in the management of mild to moderate cases of ulcerative colitis.
It is a randomized clinical trial where patients with mild to moderate ulcerative colitis who failed to respond to conventional therapy with mesalazine will randomly be divided into two groups one of them will be given prednisone and the other will be given budesonide MMX. The efficacy of Budesonide MMX and Prednisolone will be measured by the rate of clinical, laboratory, endoscopic, and histological improvement 8 weeks after randomization. Clinical assessment (the rate of bowel movements and rectal bleeding) and laboratory investigations ( complete blood count [CBC], C reactive protein[CRP], and fecal calprotectin) will be done after 4 and 8 weeks from treatment initiation. Endoscopic and histological assessments will be done at week 8. ;
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