Benefits of Trimetazidine in MAFLD Pateints

Non-Alcoholic Fatty Liver Disease Clinical Trial

— MAFLD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140953
• Other study ID #: REC-H-phBSU-23059
• Status: Recruiting
• Phase: Phase 2
• Start date: December 10, 2023
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: October 6 University
• Contact: Maha y fekry, beclore
• Phone: 01111349592
• Email: maha.youssif.ph[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• conventional treatment
conventional treatment will be taken in control group
• Furosemide or other alternatives , Niaspan or other alternatives
conventional treatment will be taken in control group
• Trimetazidine
trimetazidine and conventional therapy

Locations

Country	Name	City	State
Egypt	Maha Youssif Fekry	Giza	October 6

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence in mafld	Highly sensitive CRP in mg\L by ELIZA.	"1 Year "
Primary	incidence in mafld	Fibro scan in MHzby fibroscan apparatus	"1 Year "
Primary	incidence in mafld	ALT,AST in unit\liter by blood test.	"1 Year "
Secondary	incidence of mafld	Decrease in LDL in mg\dl,	" 1 Year"
Secondary	incidence of mafld	Triglyceride and total cholesterolin mg\dl	"1 Year "
Secondary	incidence of mafld	HOMA-IR in mg\dl	"1 year "
Secondary	incidence of mafld	IL6,TNF alpha in mg\l by eliza	"1 Year "