RecruitingEarly Phase 1NCT05610956

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


Sponsor

Tanta University

Enrollment

60 participants

Start Date

Jan 1, 2023

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether empagliflozin — a diabetes drug that also reduces inflammation — can help treat mild to moderate ulcerative colitis (UC), a chronic inflammatory bowel disease affecting the large intestine. **You may be eligible if...** - You have mild to moderate ulcerative colitis diagnosed by history, clinical signs, and confirmed by endoscopy and biopsy - Your UC severity is classified according to the Montreal classification **You may NOT be eligible if...** - You have Crohn's disease or another inflammatory bowel disease - You have a known serious allergy to empagliflozin - You are on dialysis or have severe kidney impairment (eGFR below 20 mL/min/1.73m²) - You have chronic urinary tract infections or chronic genital infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin

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.

DRUGconventional treatment

conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months


Locations(1)

Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.

Tanta, Egypt

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NCT05610956


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