Alpha Lipoic Acid in Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Mesalamine and alpha-lipoic acid
* Drug: Mesalamine and Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group (Placebo)<br>(Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily | Drug: Mesalamine and Placebo<br>* Mesalamine 1000 mg every 8 hrs. + Placebo once daily for 3 months<br>|
| Active Comparator: Group (Alpha lipoic acid)<br>(Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg | Drug: Mesalamine and alpha-lipoic acid<br>* Mesalamine 1000 mg every 8 hrs. + alpha-lipoic acid 600 mg once daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in both health related quality of life | 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 | 3 months from start of treatment | 
| Change in disease severity | Partial Mayo Scoring Index which evaluate severity through total score whether higher scores mean a worse and lower score mean a better outcome. | 3 months from start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fecal calprotectin as biological parameters | measure Fecal calprotectin which lower result means a better outcome | 3 months from start of treatment | 
| Change in reduced glutathione as biological parameters | measure reduced glutathione which lower result means a better outcome | 3 months from start of treatment | 
| Change in interleukin-6 as biological parameters | measure interleukin-6 which lower result mean better outcome. | 3 months from start of treatment | 
| Change in Transforming growth factor - beta 1 as biological parameters | measure Transforming growth factor - beta 1 which lower result mean better outcome. | 3 months from start of treatment |