Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• •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.
Locations
Other Locations
Egypt
Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.
RECRUITING
Tanta
Contact Information
Primary
youmna H eldeeb, phD
youmnahamdyeldeeb@gmail.com
01014860930
Backup
Sahar M Elhaggar
01008838807
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Tanta University