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The exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Due to genetic, immune, and environmental factors, UC is highly dependent on cellular immune reactions and exaggerated inflammatory responses. The release of several cytokines, kinins, leukotrienes, platelet-activating factor (PAF), and reactive oxygen species is connected to immunological activity (ROS). Additionally, many of the cytokines will start an acute phase response, making the inflammation worse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | this group will take mesalamine 1 g three times daily | |
| Pentoxifylline group | Active Comparator | his group will take mesalamine 1 g three times daily plus pentoxifylline 400 mg two times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentoxifylline 400 MG | Drug | Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics. PTX exerts anti-inflammatory effects by inhibiting phosphodiesterase and activating the adenosine 2 receptor |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in health related quality of life | Short Form 36 Health Survey (SF-36) will assess the quality of life. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the level of measured biomarkers. | changes in the level of measured biomarkers through assessment serum level of TNF- alpha, serum IL-10, and gene expression of zonula occuldin-1(ZO-1). | 6 months |
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Inclusion Criteria:
Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception
Exclusion Criteria:
- Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Known allergy to the studied medications
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| Name | Affiliation | Role |
|---|---|---|
| Mostafa M Bahaa, PhD | Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Mansoura University | Al Mansurah | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39192162 | Derived | Bahaa MM, Hegazy SK, Maher MM, Bahgat MM, El-Haggar SM. Pentoxifylline in patients with ulcerative colitis treated with mesalamine by modulation of IL-6/STAT3, ZO-1, and S1P pathways: a randomized controlled double-blinded study. Inflammopharmacology. 2024 Oct;32(5):3247-3258. doi: 10.1007/s10787-024-01560-6. Epub 2024 Aug 27. |
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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 |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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double-blinded
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |