Benefits of Trimetazidine in MASLD Patients

NCT ID: NCT06140953

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-10

Study Completion Date

2024-11-30

Brief Summary

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Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD

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

Conditions

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Metabolic Associated Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo group (conventional treatment + placebo tablet)

placebo tablet (inert substance) + Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy

Group Type PLACEBO_COMPARATOR

Conventional therapy

Intervention Type DRUG

conventional therapy

Placebo

Intervention Type DRUG

placebo tablet (inert substance has the same shape and color of intervention) to be taken by control group only

intervention group: drug trimetazidine

trimetazidine 20 mg three times Aday plus lifestyle modification

Group Type EXPERIMENTAL

Trimetazidine

Intervention Type DRUG

trimetazidine at dose 20 mg three times daily to be taken by intervention group

Conventional therapy

Intervention Type DRUG

conventional therapy

Interventions

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Trimetazidine

trimetazidine at dose 20 mg three times daily to be taken by intervention group

Intervention Type DRUG

Conventional therapy

conventional therapy

Intervention Type DRUG

Placebo

placebo tablet (inert substance has the same shape and color of intervention) to be taken by control group only

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* alternative steatosis causes (alcohol intake \>50 g/day women or \>60 g/day men
* drug-induced injury, hepatitis C, Wilson disease).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Maha youssif

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hoda m rabea, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Beni-suaf university

Locations

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Beni-Suef university

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC-H-phBSU-23059

Identifier Type: -

Identifier Source: org_study_id

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