Clinical trial

Evaluation of the Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease

Name
REC-H-PhBSU-23006
Description
Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD
Trial arms
Trial start
2023-12-28
Estimated PCD
2024-12-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Itopride
itopride will be taken by pateints one time per day by dose 100 mg
Arms:
interventions: drug itopride
conventional therapy
will taken by patient in control group
Arms:
control group, interventions: drug itopride
Other names:
Anti hypertensive druds, anti hyperlipidemic drugs
Size
60
Primary endpoint
incidence of MAFLD
"1 Year "
Eligibility criteria
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 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 * 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 * probiotics or anti-secretory drugs capable of causing achlorhydria within 2 months preceding enrolmentwere also considered exclusion criteria. * Patient with age below 18 or above 60
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-10-31

1 organization

2 products

2 indications

Product
Itopride
Indication
Fatty Liver