Evaluation of the Effect of Rutin and Vitamin C in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- • Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12.
研究概览
简要总结
暂无简介。
详细描述
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a common liver disorder with risks of progression to fibrosis, cirrhosis, and hepatocellular carcinoma.
Its global prevalence is high, driven by oxidative stress and impaired antioxidant defenses, while no approved pharmacological treatments currently exist. Nutritional agents such as vitamin C and rutin show promise in improving liver function and reducing oxidative damage.
This study will evaluate their combined effects in addressing MASLD's multifactorial pathology.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Metabolic-Associated Steatotic Liver Disease (MASLD).
排除标准
- •HCV infection.
- •HBV infection.
- •Patients with a history of significant alcohol consumption.
- •Autoimmune hepatitis.
- •Celiac disease (CD).
- •Wilson's disease (WD).
- •Haemochromatosis.
- •Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, steroids and immunosuppressive agents, oral contraceptive pills, or drugs that can affect liver profile.
- •Hypo or hyper thyroidism.
- •Bypass surgeries.
- •TPN (Total Parenteral Nutrition).
- •Pregnant individuals or patients planning to become pregnant.
研究组 & 干预措施
Ruta C group
Drug: Rutin + Vitamin C - Oral, two tablets containing 60 mg Rutin + 160 mg Vitamin C, three times daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise).
干预措施: Rutin + Vitamin C (Drug)
结局指标
主要结局
• Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12.
时间窗: 12 weeks
Serum TNF-α, a key biomarker of inflammation in MASLD
次要结局
- • Change in serum malondialdehyde (MDA) levels from baseline to week 12.(12 weeks)
研究者
Shaimaa salem
Ain Shams University
Ain Shams University