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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Control group) | Placebo Comparator | which will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group |
|
| Group II (Desloratadine group) | Active Comparator | which will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine | Drug | mesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease activity and severity | Change in disease activity and severity through Partial Mayo Scoring Index (PMSI) and Truelove and Witt's classification | over a 3 month follow -up period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum biomarkers | Change in serum biomarkers of inflammation and oxidative stress (TNF-α & MDA) | Change from baseline in serum biomarker over 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romisaa R Abd Alnapy | Contact | +201288667650 | PG_182624@pharm.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Romisaa R Abd Alnapy | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menofia university Hospitals | Recruiting | Shibīn al Kawm | Menofia | 32511 | Egypt |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| mesalamine | Drug | mesalamine 1000 mg three times daily for 3 months |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |