NCT07333716

Desloratadine in Patients With Ulcerative Colitis

Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Ulcerative Colitis (UC)
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Desloratadine	mesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months.
DRUG	mesalamine	mesalamine 1000 mg three times daily for 3 months

Timeline

• Start date: 2026-01-26
• Primary completion: 2027-02-01
• Completion: 2027-03-01
• First posted: 2026-01-12
• Last updated: 2026-01-29

Locations

1 site across 1 country: Egypt