Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)

Study Overview
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Brief Summary
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Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD

Detailed Description
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the study will evaluate the possible benefits of itopride when added to pateints with metabolic associated fatty liver disease

Official Title
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Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease

Conditions
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Fatty Liver Disease, Fatty Liver

Intervention / Treatment
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* Drug: Itopride
* Drug: conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presented to hepatology clinic . -Patients are diagnosed by ultrasonography and laboratory tests for liver and lipids. - - Patients with comorbidites like hypertension,diabetes,dyslipidemia Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>• control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy | Drug: conventional therapy<br>* will taken by patient in control group<br>* Other names: Anti hypertensive druds, anti hyperlipidemic drugs;|
| Experimental: interventions: drug itopride<br>• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy | Drug: Itopride<br>* itopride will be taken by pateints one time per day by dose 100 mg<br>Drug: conventional therapy<br>* will taken by patient in control group<br>* Other names: Anti hypertensive druds, anti hyperlipidemic drugs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of MAFLD | Highly sensitive CRP in mg\L by ELIZA, Fibro scan in MHzby fibroscan apparatus, ALT,AST in unit\liter by blood test | 1 Year  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of mafld | Decrease LDL in mg\dl, Triglyceride and total cholesterolin mg\dl ,HOMA-IR in mg\dl, IL6,TNF alpha in mg\l by eliza |  1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Itopride in Mafld