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

Fatty Liver Clinical Trial

— MAFLD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05966025
• Other study ID #: REC-H-PhBSU-23006
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 28, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: October 6 University
• Contact: Maha y fekry, beclore
• Phone: 01111349592
• Email: maha.youssif.ph[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver Disease
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Itopride
itopride will be taken by pateints one time per day by dose 100 mg
• conventional therapy
will taken by patient in control group

Locations

Country	Name	City	State
Egypt	Maha Youssif Fekry	Giza

Sponsors (2)

Lead Sponsor	Collaborator
October 6 University	Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of mafld	Decrease LDL in mg\dl, Triglyceride and total cholesterolin mg\dl ,HOMA-IR in mg\dl, IL6,TNF alpha in mg\l by eliza	" 1 Year"