Clinical Study to Evaluate Safety and Efficacy of Rupatadine 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 condition that primarily targets the large intestine. Although substantial progress has been made in treatment modalities-especially with the development of immunomodulatory drugs and biologic therapies-managing UC continues to present significant challenges. At present, there is no definitive cure, and current treatment strategies are largely focused on controlling inflammation, relieving symptoms, and halting disease progression
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
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
Contact Information
Primary
Reham Elshafiey, PhD
rehamelshafiey@gmail.com
01025465180
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2026-10-21
Participants
Target number of participants: 60
Treatments
Active_comparator: Control group
control group (Mesalamine group) who will receive 1 g mesalamine three times daily for 3 months.
Active_comparator: Rupatadine
(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once 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