Clinical Study Evaluating the Efficacy and Safety of Alpha-lipoic Acid in Patients With Ulcerative Colitis Treated With Mesalamine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in disease severity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
Group (Placebo)
(Placepo group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo once daily
干预措施: "Mesalamine" and "Placebo" (Drug)
Group (Alpha lipoic acid)
(Alpha-lipoic acid group; n=30) which will receive mesalamine 1000 mg three times daily plus alpha-lipoic acid 600 mg
干预措施: "Mesalamine" and "alpha-lipoic acid" (Drug)
结局指标
主要结局
Change in disease severity
时间窗: 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.
Change in both health related quality of life
时间窗: 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
次要结局
- Change in "reduced glutathione" as biological parameters(3 months from start of treatment)
- Change in "interleukin-6" as biological parameters(3 months from start of treatment)
- Change in "Transforming growth factor - beta 1" as biological parameters(3 months from start of treatment)
- Change in "fecal calprotectin" as biological parameters(3 months from start of treatment)
研究者
Ahmed Elsayed Farouk
Clinical pharmacy manager
Tanta University