Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
MAFLD
Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease
1 other identifier
interventional
60
1 country
1
Brief Summary
Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2023
CompletedFirst Posted
Study publicly available on registry
July 28, 2023
CompletedStudy Start
First participant enrolled
December 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 31, 2023
October 1, 2023
11 months
July 14, 2023
October 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence of MAFLD
Highly sensitive CRP in mg\\L by ELIZA, Fibro scan in MHzby fibroscan apparatus, ALT,AST in unit\\liter by blood test
"1 Year "
Secondary Outcomes (1)
Incidence of mafld
" 1 Year"
Study Arms (2)
control group
EXPERIMENTAL• control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy
interventions: drug itopride
EXPERIMENTAL• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy
Interventions
itopride will be taken by pateints one time per day by dose 100 mg
will taken by patient in control group
Eligibility Criteria
You may qualify if:
- Patients presented to hepatology clinic . -Patients are diagnosed by ultrasonography and laboratory tests for liver and lipids. - -
- Patients with comorbidites like hypertension,diabetes,dyslipidemia
You may not qualify if:
- acute systemic disease
- cystic fibrosis, coeliac disease
- suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency
- metabolic inherited diseases
- autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone).
- Patients were also excluded if body weight and carbohydrate metabolism were altered by the use of parenteral nutrition
- protein malnutrition
- previous gastrointestinal surgery
- structural abnormalitiesof the gastrointestinal tract or neurological impairment.
- the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1
- Patient with age below 18 or above 60
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- October 6 Universitylead
- Beni-Suef Universitycollaborator
Study Sites (1)
Maha Youssif Fekry
Giza, 12573, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hoda m rabea, A Professor
Beni-suaf university
- PRINCIPAL INVESTIGATOR
Yasmine m madney, Lecturer
Beni-suaf university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Maha Youssif Fekry
Study Record Dates
First Submitted
July 14, 2023
First Posted
July 28, 2023
Study Start
December 28, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
October 31, 2023
Record last verified: 2023-10