Benefits of Trimetazidine in MAFLD Pateints

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

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

Official Title
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Evaluation of Potential Benefits of Trimetazidine in the Management of Pateints With Metabolic Associated Fatty Liver Disease ( MAFLD)

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: conventional treatment
* Drug: Furosemide or other alternatives , Niaspan or other alternatives
* Drug: Trimetazidine


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, insuline resistance , increase in west circumstanses 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 alcoholism pateints autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone) the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1 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 (conventional treatment)<br>control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy | Drug: conventional treatment<br>* conventional treatment will be taken in control group<br>* Other names: conventional treatment ( anti diabetic drugs and antihyperlipidimic drugs );Drug: Furosemide or other alternatives , Niaspan or other alternatives<br>* conventional treatment will be taken in control group<br>* Other names: conventional therapy;|
| Experimental: interventions: drug trimetazidine<br>trinetazidine group Weight reduction and life style modification and receive (trimetazidine) 20 mg three times dialy for 24 weeks plus their conventional treatment | Drug: conventional treatment<br>* conventional treatment will be taken in control group<br>* Other names: conventional treatment ( anti diabetic drugs and antihyperlipidimic drugs );Drug: Furosemide or other alternatives , Niaspan or other alternatives<br>* conventional treatment will be taken in control group<br>* Other names: conventional therapy;Drug: Trimetazidine<br>* trimetazidine and conventional therapy<br>* Other names: furosemide or other alternative , niaspan or other alternative;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of mafld | Decrease in LDL in mg\dl, |  1 Year | 
| incidence of mafld | Triglyceride and total cholesterolin mg\dl | 1 Year  | 
| incidence of mafld | HOMA-IR in mg\dl | 1 year  | 
| incidence of mafld | 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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trimetazidine in mafld