Using alpha-lipoic acid to treat ulcerative colitis
Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
This study is testing if adding alpha-lipoic acid to the usual medication for mild to moderate ulcerative colitis can help patients feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tanta) |
| Trial ID | NCT06067698 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of alpha-lipoic acid as an additional treatment alongside mesalamine for patients with mild to moderate ulcerative colitis. The approach focuses on the antioxidant and anti-inflammatory properties of alpha-lipoic acid, which may help improve the condition. Participants will be randomly assigned to receive either mesalamine with alpha-lipoic acid or mesalamine with a placebo. The study aims to determine if this combination can enhance treatment outcomes for patients newly diagnosed with this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed mild to moderate ulcerative colitis who are being treated with mesalamine.
Not a fit: Patients with severe ulcerative colitis or those with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing mild to moderate ulcerative colitis.
How similar studies have performed: While the specific combination of alpha-lipoic acid and mesalamine is novel, similar studies exploring antioxidant therapies in inflammatory bowel diseases have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Tanta
- Tanat university hospital — Tanta, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Farouk
- Email: ahmed.farouk.pharmacist@gmail.com
- Phone: +201067988063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.