RECRUITINGPhase 2INTERVENTIONAL
Desloratadine in Patients With Ulcerative Colitis
Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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).
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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
Locations (1)
Menofia university Hospitals
Shibīn al Kawm, Menofia, Egypt