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Recruiting NCT06067698

NCT06067698 Alpha Lipoic Acid in Ulcerative Colitis

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Clinical Trial Summary
NCT ID NCT06067698
Status Recruiting
Phase
Sponsor Tanta University
Condition Ulcerative Colitis
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2023-10-01
Primary Completion 2025-04-01

Trial Parameters

Condition Ulcerative Colitis
Sponsor Tanta University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-01
Completion 2025-04-01
Interventions
"Mesalamine" and "alpha-lipoic acid""Mesalamine" and "Placebo"

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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.

Eligibility Criteria

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), se

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