Alpha Lipoic Acid in Ulcerative Colitis
Recruiting · NCT06067698 · Interventional (participants receive a specific treatment) · Lead sponsor: Tanta University
View the official record on ClinicalTrials.gov →Interventions studied
"Mesalamine" and "Placebo""Mesalamine" and "alpha-lipoic acid"
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed.
- Tanat university hospital - Tanta, Egypt