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This study aims at evaluating the efficacy and safety of alpha-lipoic acid as adjuvant therapy to mesalamine in patients with mild to moderate ulcerative colitis due to its effect as anti-oxidant and anti-inflammatory drug which can help to improve disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (Placebo) | Placebo Comparator | (Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily |
|
| Group (Alpha lipoic acid) | Active Comparator | (Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Mesalamine" and "alpha-lipoic acid" | Drug | Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in both health related quality of life | The Short Inflammatory Bowel Disease Questionnaire to evaluate quality of life to the patient through score from 1 to 7 whether higher scores mean a better outcome and lower score mean a worse outcome | 3 months from start of treatment |
| Change in disease severity | Partial Mayo Scoring Index which evaluate severity through total score whether higher scores mean a worse and lower score mean a better outcome. | 3 months from start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in "fecal calprotectin" as biological parameters | measure Fecal calprotectin which lower result means a better outcome | 3 months from start of treatment |
| Change in "reduced glutathione" as biological parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Farouk | Contact | +201067988063 | ahmed.farouk.pharmacist@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanat university hospital | Recruiting | Tanta | 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 |
|---|---|
| D019804 | Mesalamine |
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| "Mesalamine" and "Placebo" | Drug | Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months |
|
measure reduced glutathione which lower result means a better outcome
| 3 months from start of treatment |
| Change in "interleukin-6" as biological parameters | measure interleukin-6 which lower result mean better outcome. | 3 months from start of treatment |
| Change in "Transforming growth factor - beta 1" as biological parameters | measure Transforming growth factor - beta 1 which lower result mean better outcome. | 3 months from start of treatment |
| 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 |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |