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Desloratadine in Patients With Ulcerative Colitis

Desloratadine in Patients With Ulcerative Colitis

Recruiting
18-65 years
All
Phase 2

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Overview

The purpose of this study is to investigate safety and therapeutic efficacy of antihistamine (desloratadine) on inflammation and disease activity when administered as adjuvant therapies with the traditional therapy 5-aminosalisylic acid (mesalamine) in patients with mild to moderate ulcerative colitis.

Description

Ulcerative colitis is a chronic inflammatory autoimmune disease affecting the colon. The World Health Organization has classified it as a relatively new treatment-resistant disease, and its prevalence has reportedly increased significantly in Egypt. A preclinical study was conducted to evaluate desloratadine as a potential therapeutic agent for ulcerative colitis, based on its known anti-inflammatory and antioxidant properties. The study concluded that desloratadine effectively alleviated experimental ulcerative colitis. This positive effect is attributed to its anti-inflammatory and antioxidant properties, which work by regulating mast cell activity and inhibiting histamine release.

Eligibility

Inclusion Criteria:

  • Both male and female sex.
  • patients with age ranged from 18 to 65.
  • patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline.
  • Patients treated with 5-aminosalisylic acid (mesalamine).

Exclusion Criteria:

  • Patients with severe UC
  • Significant liver or kidney function abnormalities
  • Pregnant or lactating females
  • Treatment with systemic or rectal steroids
  • Treatment with immunosuppressant or biological therapies
  • Known allergy to desloratadine or any ingredient in the formulation
  • Patients with other inflammatory diseases
  • Patients with history of colon cancer
  • Patients with complete or partial colectomy

Study details
    Ulcerative Colitis (UC)
    Ulcerative Colitis

NCT07333716

Tanta University

1 February 2026

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