Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis

Sponsor
Tanta University
Study ID
NCT05610956
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    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 — DRUG
    conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months

Study Details

•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.

Key Dates

Start date
Jan 1, 2023
Status verified
Jul 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo group
    Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.
  • Experimental: empagliflozin group
    Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)for 4months.

Primary Outcome Measure

clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis. [ Time Frame: 4months ]

Central Contacts

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