Status:

RECRUITING

Alpha Lipoic Acid in Ulcerative Colitis

Lead Sponsor:

Tanta University

Conditions:

Ulcerative Colitis

Ulcerative Colitis (UC)

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

October 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2025

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06067698

Start Date

October 1 2023

End Date

April 1 2025

Last Update

February 6 2025

Active Locations (1)

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1

Tanat university hospital

Tanta, Egypt