Actively Recruiting
Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
Led by Tanta University · Updated on 2025-02-06
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of alpha-lipoic acid combined with mesalamine in patients with mild to moderate ulcerative colitis. This study focuses on alpha-lipoic acid's antioxidant and anti-inflammatory properties, which may help improve the condition. The trial is designed as a randomized, single-blind study led by Tanta University. Participants will be randomly assigned to one of two groups. One group receives mesalamine 1000 mg three times daily plus a placebo once daily, while the other group receives mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg once daily. The treatment lasts for three months. During the study, participants will be monitored for changes in health-related quality of life and disease severity after three months of treatment. Biological markers such as fecal calprotectin, reduced glutathione, interleukin-6, and transforming growth factor-beta 1 will also be measured. The study includes regular assessments to track safety and effectiveness throughout the treatment period.
CONDITIONS
Brief Title
Alpha Lipoic Acid in Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Clinical Guideline for diagnosing Ulcerative Colitis in Adults
- Patients treated with 5-aminosalisylic acid (mesalamine)
You will not qualify if you...
- 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 including 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 antioxidant supplements such as vitamin A, C, E, selenium, co-enzyme Q
- Patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy due to possible drug interactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive mesalamine three times daily and either alpha-lipoic acid or placebo once daily.
Trial Site Locations
Total: 1 location
1
Tanat university hospital
Tanta, Egypt
Actively Recruiting
Research Team
A
Ahmed Farouk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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