Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Sponsor
Sadat City University
Study ID
NCT05058417
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
  • Placebo — DRUG
    participants will receive placebo for 8 consecutive weeks in addition to the standard therapy

Study Details

This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.

Key Dates

Start date
Oct 1, 2021
Status verified
Jul 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin group
    participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
  • Placebo Comparator: Placebo
    participants will receive placebo for 8 consecutive weeks in addition to the standard therapy

Primary Outcome Measure

Expression of colonic (NF)-κB proteins [ Time Frame: 8 weeks ]

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