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

NCT ID: NCT05966025

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-28

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Fatty Liver Disease Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

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

Group Type EXPERIMENTAL

conventional therapy

Intervention Type DRUG

will taken by patient in control group

interventions: drug itopride

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

Group Type EXPERIMENTAL

Itopride

Intervention Type DRUG

itopride will be taken by pateints one time per day by dose 100 mg

conventional therapy

Intervention Type DRUG

will taken by patient in control group

Interventions

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Itopride

itopride will be taken by pateints one time per day by dose 100 mg

Intervention Type DRUG

conventional therapy

will taken by patient in control group

Intervention Type DRUG

Other Intervention Names

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Anti hypertensive druds, anti hyperlipidemic drugs

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role collaborator

October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Maha youssif

Maha Youssif Fekry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hoda m rabea, A Professor

Role: PRINCIPAL_INVESTIGATOR

Beni-suaf university

Yasmine m madney, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Beni-suaf university

Locations

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Maha Youssif Fekry

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Maha y fekry, beclore

Role: CONTACT

01111349592 ext. october 6

Engy ah wahsh, Lecturer

Role: CONTACT

01003095692 ext. october 6

Facility Contacts

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maha y fekry, beclore

Role: primary

01111349592 ext. october6

Engy ah wahsh, lec o6u

Role: backup

01003095692 ext. october6

Other Identifiers

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REC-H-PhBSU-23006

Identifier Type: -

Identifier Source: org_study_id

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