Potential Benefits of Itopride in the Management of Patie... | NCT05966025

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

NCT05966025

Sponsor

October 6 University

Status

Unknown status

Last Update Posted

Oct 31, 2023Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Fatty Liver Disease
Fatty Liver

Interventions

Itopride
conventional therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2023Estimated

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jul 14, 2023

First Submission Date that Met QC Criteria

Jul 20, 2023

First Posted Date

Jul 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2023

Last Update Posted Date

Oct 31, 2023Actual

Name	Class
Beni-Suef University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Experimental	• control group Weight reduction and life style modification(modification in diet like decrease lipids intak).pateints will recieve their conventional therapy	Drug: conventional therapy
interventions: drug itopride	Experimental	• itopride group Weight reduction and life style modification and receive (itopride) 100 mg once dialy for 24 weeks plus their conventional therapy	Drug: Itopride Drug: conventional therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Itopride	Drug	itopride will be taken by pateints one time per day by dose 100 mg	interventions: drug itopride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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"

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maha y fekry, beclore	Contact	01111349592	october 6	maha.youssif.ph@o6u.edu.eg
Engy ah wahsh, Lecturer	Contact	01003095692	october 6	engywahsh@o6u.edu.eg

Overall Officials

Name	Affiliation	Role
Hoda m rabea, A Professor	Beni-suaf university	Principal Investigator
Yasmine m madney, Lecturer	Beni-suaf university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maha Youssif Fekry		Giza		12573	Egypt

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D005234	Fatty Liver

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases