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
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in both health related quality of life
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
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (受试者)
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 (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)
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)
结局指标
主要结局
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
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.
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
研究点 (2)
标识符
- NCT 编号
- NCT06067698
- 其他研究编号
- 36264MS206/6/23
日期
- 首次提交
- (3年前)
- 首次发布
- (2年前)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否