Rupatadine in Patients With Ulcerative Colitis

Alexandria University

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Mesalamine; Drug: Rupatadine

Study type: Interventional

Funder types: Other

Identifiers

NCT07064707

5555

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Both male and female will be included
• Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.

Exclusion criteria

• Breast feeding or pregnancy.
• Colorectal cancer patients.
• Patients with severe UC.
• Patients taking rectal or systemic steroids.
• Patients taking immunosuppressives or biological therapies.
• Addiction to alcohol and / or drugs.
• Known allergy to the studied medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control group

Active Comparator group

Description:

control group (Mesalamine group) who will receive 1 g mesalamine three times daily for 3 months.

Treatment:

Drug: Mesalamine

Rupatadine

Active Comparator group

Description:

(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.

Treatment:

Drug: Rupatadine

Drug: Mesalamine