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Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD
the study will evaluate the possible benefits of trimetazidine when added to pateints with metabolic associated fatty liver disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group (conventional treatment + placebo tablet) | Placebo Comparator | placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy |
|
| intervention group: drug trimetazidine | Experimental | trimetazidine 20 mg three times Aday plus lifestyle modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimetazidine | Drug | trimetazidine at dose 20 mg three times daily to be taken by intervention group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Highly sensitive CRP | Highly sensitive CRP in mg\dl by chemiillusence. | measured at baseline and at six months |
| liver Fibrosis and steatosis in db./m | liver Fibrosis and steatosis in db./m fibro scan and fibro cap apparatus | measured at baseline and at six months |
| ALT and AST | ALT, AST in IU/L by blood test. | measured at baseline and at six months |
| Controlled attenuation parameter (CAP) | A measure of hepatic fat accumulation using transient elastography (Fibro Scan); values typically range from 100 to 400 dB/m, lower values indicate improvement Unit of measure: dB/m. | measured at baseline and at six months |
| FAST Score | Fibro Scan-AST score; anon-invasive score to assess the risk of progressive MASH (Metabolic dysfunction-associated steatohepatitis). lower scores indicate improvement Unit of measure: Unitless index (range 0-1) | at baseline and at six months |
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol | Decrease in LDL in mg\dl, | measured at baseline and at six months |
| Triglyceride and total cholesterol | Triglyceride and total cholesterol in mg\dl |
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Inclusion Criteria: participants were included if they met MASLD diagnostic criteria, which required imaging-confirmed hepatic steatosis (via abdominal ultrasound and CAP), along with metabolic factors (BMI ≥25 kg/m², diabetes/dysglycemia, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dL, or reduced HDL-cholesterol)
Exclusion Criteria: The study excluded those with
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| Name | Affiliation | Role |
|---|---|---|
| Hoda m rabea, Assistant Professor | Beni-suaf university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef university | Banī Suwayf | Beni Suweif Governorate | 62511 | Egypt |
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| ID | Term |
|---|---|
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Conventional therapy | Drug | conventional therapy |
|
| Placebo | Drug | placebo tablet (inert substance has the same shape and color of intervention) to be taken by control group only |
|
| measured at baseline and at six months |
| HOMA-IR | HOMA-IR | measured at baseline and at six months |
| IL6 and TNF alpha | IL6 and TNF alpha in pg./ml by Eliza | measured at baseline and at six months |