The Effects of Ginger on Biochemical Markers and Imaging Studies of Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in ALT (liver transaminases) level
研究概览
简要总结
The investigators want to evaluate the effects and safety of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
详细描述
Ginger (Zingiber officinale Roscoe) has been cultivated for medicinal and culinary purposes for at least two millennia. It contains several hundred valuable compounds and new constituents are still being found. Ginger's high antioxidant value has proved highly effective with its ability to scavenge a number of free radicals and protect cell membrane lipids from oxidation in a dose-dependent manner.
In a randomized double-blind placebo-controlled clinical trial, the investigators want to investigate the effects of ginger in treatment of nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Controlled type 2 diabetes mellitus (HbA1c<7%)
- •Age: 20-65 years
- •Body mass index: 18-35 kg/m2
- •Serum ALT level: >60 U/Lit. in males, >38 U/Lit. in females
- •Grade >=2 fatty liver in liver sonography
排除标准
- •Pregnancy
- •Acute or chronic liver failure
- •Acute or chronic renal failure
- •Autoimmune or viral hepatitis
- •Wilson's disease
- •Alcoholism
- •Malignancy
- •Hypothyroidism or hyperthyroidism
- •Drug used in last three months: OCP, vitamin E, ursodeoxycholic acid, glucocorticoids.
研究组 & 干预措施
Ginger
Ginger powder capsule 500 mg
干预措施: Ginger (Drug)
Placebo
Placebo powder capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Change in ALT (liver transaminases) level
时间窗: Baseline and 3 months
Change in the concentration of ALT (liver transaminases)
Change in score of fatty liver in fibroscan
时间窗: Baseline and 3 months
Change in score of fatty liver in fibroscan (elastography)
次要结局
- Change in AST (liver transaminases) level(Baseline and 3 months)
- Change in Gama GT (γ-glutamyl transpeptidase) levels(Baseline and 3 months)
- Number of patients with adverse events(4 months)
研究者
Mesbah Shams, MD
Associate professor of Internal Medicine & Endocrinology
Shiraz University of Medical Sciences