"Mesalamine" and "alpha-lipoic acid""Mesalamine" and "Placebo"
"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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥18 years old.
* 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 severe ulcerative colitis.
* 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).
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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