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| Name | Class |
|---|---|
| Mounir Hussein Bahgat Internal Medicine Department Mansoura University | UNKNOWN |
| Maha Mohamed Maher Internal Medicine Department Mansoura University | UNKNOWN |
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Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | this group will take mesalamine 1 gm three times daily for 6 months | |
| metformin group | Active Comparator | this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the change in partial mayo score index | The Partial Mayo Score index is a non-invasive clinical scale used to assess the severity of ulcerative colitis. It is a composite of sub scores from three categories, including stool frequency, rectal bleeding, and physician's global assessment, with a total score ranging from 0-9 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha | The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Mansoura University | Al Mansurah | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40191419 | Derived | Binsaleh AY, El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Elmasry TA, Alrubia S, Alsegiani AS, Eldesoqui M, Bahaa MM. The adjunctive role of metformin in patients with mild to moderate ulcerative colitis: a randomized controlled study. Front Pharmacol. 2025 Mar 19;16:1507009. doi: 10.3389/fphar.2025.1507009. eCollection 2025. | |
| 38917525 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| El-Haggar SM, Hegazy SK, Maher MM, Bahgat MM, Bahaa MM. Repurposing metformin as adjuvant therapy in patients with ulcerative colitis treated with mesalamine: A randomized controlled double-blinded study. Int Immunopharmacol. 2024 Sep 10;138:112541. doi: 10.1016/j.intimp.2024.112541. Epub 2024 Jun 24. |