Ulcerative Colitis, Ulcerative Colitis (UC)
Conditions
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 anti-inflammatory drug which can help to improve disease.
Interventions
DRUGMesalamine and alpha-lipoic acid
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
DRUGMesalamine and Placebo
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in both health related quality of life | 3 months from start of treatment | The Short Inflammatory Bowel Disease Questionnaire to evaluate quality of life to the patient through score from 1 to 7 whether higher scores mean a better outcome and lower score mean a worse outcome |
| Change in disease severity | 3 months from start of treatment | Partial Mayo Scoring Index which evaluate severity through total score whether higher scores mean a worse and lower score mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal calprotectin as biological parameters | 3 months from start of treatment | measure Fecal calprotectin which lower result means a better outcome |
| Change in reduced glutathione as biological parameters | 3 months from start of treatment | measure reduced glutathione which lower result means a better outcome |
| Change in interleukin-6 as biological parameters | 3 months from start of treatment | measure interleukin-6 which lower result mean better outcome. |
| Change in Transforming growth factor - beta 1 as biological parameters | 3 months from start of treatment | measure Transforming growth factor - beta 1 which lower result mean better outcome. |
Countries
Egypt
Contacts
Primary ContactAhmed Farouk
Outcome results
None listed