Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis
Tanta University
60 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
Summary
•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.
Eligibility
Inclusion Criteria1
- •Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis.
Exclusion Criteria6
- Other inflammatory bowel diseases (CD).
- History of serious hypersensitivity to empagliflozin or any component of the formulation.
- Patients on dialysis.
- Severe renal impairment (eGFR \<20 ml/minute/1.73m2) .
- Chronic urinary tract infection.
- Chronic genital infection.
Interventions
Patients will receive empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)and conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months.
conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05610956