Tanat university hospital
Tanta, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT06067698
Alpha Lipoic Acid in Ulcerative Colitis
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
"Mesalamine" and "alpha-lipoic acid"
DrugMesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months
"Mesalamine" and "Placebo"
DrugMesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months
Primary outcomes
-
Change in both health related quality of life
Time frame: 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
Time frame: 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 outcomes
-
Change in "fecal calprotectin" as biological parameters
Time frame: 3 months from start of treatment
measure Fecal calprotectin which lower result means a better outcome
-
Change in "reduced glutathione" as biological parameters
Time frame: 3 months from start of treatment
measure reduced glutathione which lower result means a better outcome
-
Change in "interleukin-6" as biological parameters
Time frame: 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
Time frame: 3 months from start of treatment
measure Transforming growth factor - beta 1 which lower result mean better outcome.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Tanta University
Other
Registry information
Official study title
Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Oct 5, 2023
- Registry last updated
- Feb 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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