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
Organization
October 6 UniversityProduct
ItoprideIndication
Fatty Liver DiseaseIndication
Fatty LiverProduct
Conventional therapy