Clinical trial
Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
Name
36264MS206/6/23
Description
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.
Trial arms
Trial start
2023-10-01
Estimated PCD
2024-07-01
Trial end
2024-10-01
Status
Not yet recruiting
Treatment
"Mesalamine" and "alpha-lipoic acid"
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
Arms:
Group (Alpha lipoic acid)
"Mesalamine" and "Placebo"
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
Arms:
Group (Placebo)
Size
60
Primary endpoint
Change in both health related quality of life
3 months from start of treatment
Change in disease severity
3 months from start of treatment
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), selenium, co-enzyme Q.
* Patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy (drug-drug interaction).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-10-10
1 organization
Organization
Tanta University