Ulcerative Colitis Clinical Trial
Official title:
Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis
•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.
- It will be conducted on 60 patients having with mild to moderate degree UC divided into two groups: 1. Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid). 2. Group 2 (n=30): Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day). - The patient will be selected from the Gastroenterology and Endoscopy Unit, Internal Medicine. . All patients will be subjected to the following: - Complete history taking. - Colonoscopy with intubation of the ileum and biopsies of affected and unaffected areas should be obtained to confirm the diagnosis of UC. - Blood sample collection to assess: A) Routine Laboratory tests 1. Complete blood picture (CBC). 2. Liver functions (ALT, AST, Total and Direct Bilirubin). 3. Kidney functions tests (Urea, serum creatinine). 4. C-reactive protein. 5. Fasting blood glucose. 6. Urine analysis. B) Specific Laboratory tests 1. Tumor necrosis factor alpha (TNF-α). 2. Adenosine monophosphate kinase (9AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters ;
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