Clinical Study to Evaluate Safety and Efficacy of Nitazoxanide in Patients With Ulcerative Colitis.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Ulcerative colitis (UC) is a chronic inflammatory bowel Disease (IBD) that primarily affects the rectum and colon. The severity and persistence of mucosal inflammation are associated with morbidity and mortality.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Both male and female will be included
• Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.
Locations
Other Locations
Egypt
Alexandria University
RECRUITING
Alexandria
Time Frame
Start Date: 2025-05-30
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 70
Treatments
Active_comparator: Control group
Control group, n =35: who will receive 1 g mesalamine three times daily for 3 months.
Active_comparator: Nitazoxanide group
Nitazoxanide group, n= 35: will receive 1 g mesalamine three times daily plus nitazoxanide 500 mg twice daily for 3 months.
Related Therapeutic Areas
Sponsors
Collaborators: Assoc. Prof. Dr. Ibrahim Fathi Amer, Faculty of Medecine, Kafr Elsheikh University., Assoc. Prof. Dr. Noha Alaa Eldin Hassan Hamdy, Faculty of pharmacy, Alexandria University., Prof. Dr. Ahmed Ibrahim Mohammed El Mallah, faculty of pharmacy, Alexandria University.
Leads: Alexandria University