Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change in disease activity and severity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both male and female sex.
- •patients with age ranged from 18 to
- •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
Arms & Interventions
Group I (Control group)
which will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group
Intervention: mesalamine (Drug)
Group II (Desloratadine group)
which will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months
Intervention: Desloratadine (Drug)
Outcomes
Primary Outcomes
Change in disease activity and severity
Time Frame: over a 3 month follow -up period
Change in disease activity and severity through Partial Mayo Scoring Index (PMSI) and Truelove and Witt's classification
Secondary Outcomes
- Change in serum biomarkers(Change from baseline in serum biomarker over 3 months)
Investigators
Romisaa Raafat Abd Alnapy Mohamed
clinical pharmacy resident
Tanta University