Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)

October 6 University

Status and phase: Not yet enrolling; Phase 2

Conditions: Fatty Liver; Fatty Liver Disease

Treatments: Drug: conventional therapy; Drug: Itopride

Study type: Interventional

Funder types: Other

Identifiers

NCT05966025

REC-H-PhBSU-23006

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

control group

Experimental group

Description:

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

Treatment:

Drug: conventional therapy

interventions: drug itopride

Experimental group

Description:

• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy

Treatment:

Drug: Itopride

Drug: conventional therapy