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Benefits of Trimetazidine in MAFLD Pateints

Sponsor
October 6 University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06140953
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
20.7
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: conventional treatment
  • Drug: Furosemide or other alternatives , Niaspan or other alternatives
  • Drug: Trimetazidine
 Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Potential Benefits of Trimetazidine in the Management of Pateints With Metabolic Associated Fatty Liver Disease ( MAFLD)
Anticipated Study Start Date :
Dec 10, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: control group (conventional treatment)

control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy

Drug: conventional treatment
conventional treatment will be taken in control group
Other Names:
  • conventional treatment ( anti diabetic drugs and antihyperlipidimic drugs )

    • Drug: Furosemide or other alternatives , Niaspan or other alternatives
    conventional treatment will be taken in control group
    Other Names:
  • conventional therapy

    		•
    Experimental: interventions: drug trimetazidine

    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
    conventional treatment will be taken in control group
    Other Names:
  • conventional treatment ( anti diabetic drugs and antihyperlipidimic drugs )

    • Drug: Furosemide or other alternatives , Niaspan or other alternatives
    conventional treatment will be taken in control group
    Other Names:
  • conventional therapy

    • Drug: Trimetazidine
    trimetazidine and conventional therapy
    Other Names:
  • furosemide or other alternative , niaspan or other alternative

    		•

    Outcome Measures

    Primary Outcome Measures

    1. incidence in mafld ["1 Year "]

      Highly sensitive CRP in mg\L by ELIZA.

    2. incidence in mafld ["1 Year "]

      Fibro scan in MHzby fibroscan apparatus

    3. incidence in mafld ["1 Year "]

      ALT,AST in unit\liter by blood test.

    Secondary Outcome Measures

    1. incidence of mafld [" 1 Year"]

      Decrease in LDL in mg\dl,

    2. incidence of mafld ["1 Year "]

      Triglyceride and total cholesterolin mg\dl

    3. incidence of mafld ["1 year "]

      HOMA-IR in mg\dl

    4. incidence of mafld ["1 Year "]

      IL6,TNF alpha in mg\l by eliza

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maha Youssif Fekry Giza October 6 Egypt 12573

    Sponsors and Collaborators

    • October 6 University

    Investigators

    • Principal Investigator: Hoda m rabea, Assistant Professor, Beni-suaf university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maha youssif, principal investigator, October 6 University
    ClinicalTrials.gov Identifier:
    NCT06140953
    Other Study ID Numbers:
    • REC-H-phBSU-23059
    First Posted:
    Nov 21, 2023
    Last Update Posted:
    Nov 21, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Maha youssif, principal investigator, October 6 University
    trimetazidine in mafld
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Niacin
    Nicotinic Acids
    Hypoglycemic Agents
    Furosemide
    Trimetazidine

    Study Results

    No Results Posted as of Nov 21, 2023