Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence of MAFLD
研究概览
简要总结
Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD
详细描述
the study will evaluate the possible benefits of itopride when added to pateints with metabolic associated fatty liver disease
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presented to hepatology clinic . -Patients are diagnosed by ultrasonography and laboratory tests for liver and lipids. - -
- •Patients with comorbidites like hypertension,diabetes,dyslipidemia
排除标准
- •Exclusion criteria included the presence of liver disease due to any of the following: viral hepatitis (HBV, HCV)
- •acute systemic disease
- •cystic fibrosis, coeliac disease
- •suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency
- •metabolic inherited diseases
- •autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone).
- •Patients were also excluded if body weight and carbohydrate metabolism were altered by the use of parenteral nutrition
- •protein malnutrition
- •previous gastrointestinal surgery
- •structural abnormalitiesof the gastrointestinal tract or neurological impairment.
- •the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1
- •probiotics or anti-secretory drugs capable of causing achlorhydria within 2 months preceding enrolmentwere also considered exclusion criteria.
- •Patient with age below 18 or above 60
研究组 & 干预措施
control group
• control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy
干预措施: conventional therapy (Drug)
interventions: drug itopride
• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy
干预措施: Itopride (Drug)
interventions: drug itopride
• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy
干预措施: conventional therapy (Drug)
结局指标
主要结局
incidence of MAFLD
时间窗: "1 Year "
Highly sensitive CRP in mg\\L by ELIZA, Fibro scan in MHzby fibroscan apparatus, ALT,AST in unit\\liter by blood test
次要结局
- Incidence of mafld(" 1 Year")
研究者
Maha youssif
Maha Youssif Fekry
October 6 University