Ulcerative Colitis, Ulcerative Colitis (UC)
Conditions
Keywords
Ulcerative Colitis, Desloratadine
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.
Interventions
DRUGDesloratadine
mesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months.
DRUGmesalamine
mesalamine 1000 mg three times daily for 3 months
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in disease activity and severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in serum biomarkers | Change from baseline in serum biomarker over 3 months | Change in serum biomarkers of inflammation and oxidative stress (TNF-α \& MDA) |
Countries
Egypt
Contacts
CONTACTRomisaa R Abd Alnapy
PRINCIPAL_INVESTIGATORRomisaa R Abd Alnapy
Tanta University
Outcome results
None listed