Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect of Nigella Sativa on Liver Triglyceride Concentration
研究概览
简要总结
The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.
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 (Investigator)
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
- •Patients suffering from Steatohepatitis
- •Patients suffering from Liver Steatosis
排除标准
- •Patients suffering from viral hepatitis
- •Patients with HIV infection
- •Patients suffering from Wilsons Disease
研究组 & 干预措施
Patients receiving a placebo tablet
Twenty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest placebo capsules twice a day, that look like the capsules of those receiving the Nigella Sativa.
干预措施: Placebo (Dietary Supplement)
Nigella Sativa Supplement
Fifty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest capsules containing 2 grams of Nigella Sativa divided into 1 grams twice a day.
干预措施: Nigella Sativa (Dietary Supplement)
结局指标
主要结局
Effect of Nigella Sativa on Liver Triglyceride Concentration
时间窗: One year
The difference in change in the average liver triglyceride concentration will be measured by MRI Spectroscopy between the Nigella Sativa arm and the placebo arm, at start and end of the study.
次要结局
- Effect of Nigella Sativa on Improvement in NASH Activity Index(One year)
- Effect of Nigella Sativa on Fibrosis Staging(One year)