Alpha Lipoic Acid in Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: "Mesalamine" and "alpha-lipoic acid", "Mesalamine" and "Placebo".
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis, Ulcerative Colitis (UC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
Overview
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
- Drug "Mesalamine" and "alpha-lipoic acid"
Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months - Drug "Mesalamine" and "Placebo"
Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
Primary outcome measures
- Change in both health related quality of life [Time frame: 3 months from start of treatment]
- Change in disease severity [Time frame: 3 months from start of treatment]
Secondary outcome measures (4)
- Change in "fecal calprotectin" as biological parameters [Time frame: 3 months from start of treatment]
- Change in "reduced glutathione" as biological parameters [Time frame: 3 months from start of treatment]
- Change in "interleukin-6" as biological parameters [Time frame: 3 months from start of treatment]
- Change in "Transforming growth factor - beta 1" as biological parameters [Time frame: 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanat university hospital — Tanta
Identifiers
NCT: NCT06067698 · 36264MS206/6/23