Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-10-01
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group (Placebo)
(Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily
"Mesalamine" and "Placebo"
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
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
"Mesalamine" and "alpha-lipoic acid"
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
Interventions
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"Mesalamine" and "alpha-lipoic acid"
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
"Mesalamine" and "Placebo"
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
Eligibility Criteria
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Inclusion Criteria
* Both male and female sex.
* 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
* Patients treated with 5-aminosalisylic acid (mesalamine).
Exclusion Criteria
* Patients with colorectal cancer.
* Patients on rectal or systemic steroids.
* Patients on immunosuppressants or biological therapies.
* Patients with previously failed treatment with sulphasalazine.
* Patients with known allergy to study medications.
* History of complete or partial colectomy.
* Patients with significant liver disease (fibrosis, cirrhosis, NASH, NAFLD).
* Patients with other inflammatory diseases.
* Patients with thyroid diseases.
* Patients with arrhythmia, ischemic heart disease, and heart failure.
* Patients with diabetes.
* Patients on antioxidants supplement (vitamin A, C, E), selenium, co-enzyme Q.
* Patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy (drug-drug interaction).
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Ahmed Elsayed Farouk
Clinical pharmacy manager
Locations
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Tanat university hospital
Tanta, , Egypt
Countries
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Central Contacts
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Other Identifiers
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36264MS206/6/23
Identifier Type: -
Identifier Source: org_study_id
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