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Clinical trial

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

ID
Name
REC-H-phBSU-23059
Description
Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MAFLD
Trial arms
Trial start
2023-12-10
Estimated PCD
2024-06-01
Trial end
2025-09-01
Status
Recruiting
Phase
Early phase I
Treatment
conventional treatment
conventional treatment will be taken in control group
Arms:
control group (conventional treatment), interventions: drug trimetazidine
Other names:
conventional treatment ( anti diabetic drugs and antihyperlipidimic drugs )
Furosemide or other alternatives , Niaspan or other alternatives
conventional treatment will be taken in control group
Arms:
control group (conventional treatment), interventions: drug trimetazidine
Other names:
conventional therapy
Trimetazidine
trimetazidine and conventional therapy
Arms:
interventions: drug trimetazidine
Other names:
furosemide or other alternative , niaspan or other alternative
Size
60
Primary endpoint
incidence in mafld
"1 Year "
incidence in mafld
"1 Year "
incidence in mafld
"1 Year "
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-11-21

1 organization

3 products

1 indication

Organization
October 6 University
Product
Conventional Treatment
Indication
Nonalcoholic Fatty Liver Disease
Product
Furosemide
Product
Trimetazidine