Alpha Lipoic Acid in Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Mesalamine; Thioctic Acid

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), selenium, co-enzyme Q.

• Patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy (drug-drug interaction).