Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Liver stiffness change
研究概览
简要总结
This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Two group use capsules which contain TFG or placebo, respectively.
详细描述
This study design to examine performance of trigonella foenum-graecum in treatment of non-alcoholic fatty liver disease. Patients 18-70 year old with the levels of ALT and AST greater than 1.5 and less than 10 times normal level, and ultrasound evidence confirm fatty liver disease include in study. Patients with alcohol consumption, other liver disease and taking medications that cause liver injury, exclude. Base on inclusion and exclusion criteria, 50 patients select and then randomize into intervention and control groups. Control group, in addition to diet and exercise recommendations take placebo capsules for 3 months. Intervention group, in addition to diet and exercise recommendations, use capsules containing hydro-alcoholic extract of fenugreek 1g/d for 3 months. At baseline and 6 and 12 weeks after intervention, the investigators measure FBS, insulin, insulin resistance, Albumin, Aspartate transaminase, Alanine Aminotransferase, Alkaline phosphatase, Total bilirubin, Direct bilirubin, HbA1c, total cholesterol, LDL, HDL, TG, High sensitivity C reactive protein and Creatinine. At baseline and 12 weeks after intervention fibroscan perform to evaluate the amount of fat in liver. In order to decrease bias, patient, physician who performs fibroscan and the person analyzing the data are blind to group drugs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Drug: Trigonella Foenum-graecum
in this group patients use Trigonella Foenum-graecum seed extract twice daily.
干预措施: Trigonella Foenum-graecum Seed Extract (Drug)
结局指标
主要结局
Liver stiffness change
时间窗: At baseline and 12 weeks after intervention
Assessment by Fibroscan
次要结局
未报告次要终点
研究者
Amir Hossein Babaei
Students of Medicine
Shiraz University of Medical Sciences
