Desloratadine in Patients With Ulcerative Colitis (UC)

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Ulcerative Colitis; Ulcerative Colitis (UC)

Treatments: Drug: mesalamine; Drug: Desloratadine

Study type: Interventional

Funder types: Other

Identifiers

NCT07333716

12/2025 TRop1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups, including a placebo group

Group I (Control group)

Placebo Comparator group

Description:

which will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group

Treatment:

Drug: mesalamine

Group II (Desloratadine group)

Active Comparator group

Description:

which will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months

Treatment:

Drug: Desloratadine