Rupatadine in Patients With Ulcerative Colitis

Not Applicable

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mesalamine; Drug: Rupatadine

• Registration Number: NCT07064707
• Lead Sponsor: Alexandria University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-06
• Study First Submitted QC: 2025-07-06
• Last Update Submitted: 2025-07-06
• Study Start: 2025-07-15
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2026-07-15
• Study Completion: 2026-10-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Mesalamine	control group (Mesalamine group) who will receive 1 g mesalamine three times daily for 3 months.
Rupatadine	Mesalamine	(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.
Rupatadine	Rupatadine	(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.

Primary Outcome Measures

Name	Time	Method
change in partial mayo score	3 months	The Partial Mayo Score (PMS) index will be utilized to ascertain the degree of disease severity. One non-invasive clinical measure for determining the severity of UC is the PMS. The composite score is derived from three subcategories: stool frequency, rectal bleeding, and physician's general assessment. The total score falls between 0 and 9