Alpha Lipoic Acid in Ulcerative Colitis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Group (Placebo) (Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily |
Drug: "Mesalamine" and "Placebo"
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
|
| Active Comparator: Group (Alpha lipoic acid) (Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg |
Drug: "Mesalamine" and "alpha-lipoic acid"
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
|
Outcome Measures
Primary Outcome Measures
- Change in both health related quality of life [3 months from start of treatment]
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
- Change in disease severity [3 months from start of treatment]
Partial Mayo Scoring Index which evaluate severity through total score whether higher scores mean a worse and lower score mean a better outcome.
Secondary Outcome Measures
- Change in "fecal calprotectin" as biological parameters [3 months from start of treatment]
measure Fecal calprotectin which lower result means a better outcome
- Change in "reduced glutathione" as biological parameters [3 months from start of treatment]
measure reduced glutathione which lower result means a better outcome
- Change in "interleukin-6" as biological parameters [3 months from start of treatment]
measure interleukin-6 which lower result mean better outcome.
- Change in "Transforming growth factor - beta 1" as biological parameters [3 months from start of treatment]
measure Transforming growth factor - beta 1 which lower result mean better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years old.
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Both male and female sex.
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Newly diagnosed patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline for diagnosing Ulcerative Colitis in Adults.26
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Patients treated with 5-aminosalisylic acid (mesalamine).
Exclusion Criteria:
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Patients with severe ulcerative colitis.
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Patients with colorectal cancer.
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Patients on rectal or systemic steroids.
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Patients on immunosuppressants or biological therapies.
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Patients with previously failed treatment with sulphasalazine.
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Patients with known allergy to study medications.
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History of complete or partial colectomy.
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Patients with significant liver disease (fibrosis, cirrhosis, NASH, NAFLD).
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Patients with other inflammatory diseases.
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Patients with thyroid diseases.
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Patients with arrhythmia, ischemic heart disease, and heart failure.
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Patients with diabetes.
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Patients on antioxidants supplement (vitamin A, C, E), selenium, co-enzyme Q.
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Patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy (drug-drug interaction).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tanta University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 36264MS206/6/23