search
Back to results

Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease

Primary Purpose

Fatty Liver, Nonalcoholic

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Cilostazol 50 MG
Placebo
Sponsored by
Sadat City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver, Nonalcoholic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults between 18 and 60 years of age, both men and women,
  • Clinical diagnosis of NAFLD, confirmed by imaging exams,
  • Patients who present levels above the reference values of ALT, AST and ferritin.

Exclusion Criteria:

  • Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation.
  • Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification)
  • Patients with schistosomiasis;
  • Hemochromatosis
  • Wilson's disease
  • Viral or autoimmune hepatitis
  • HIV virus carriers
  • Woman who is breastfeeding
  • Users of illicit drugs
  • Patients with an intake of more than 20 g / day of alcohol and / or past alcoholism with abstention less than 6 months;
  • Patients with ingestion of medications such as steroids, estrogens, amiodarone, warfarin, anti-convulsants, antipsychotics, tamoxifen or other chemotherapeutic agents in the last 6 months
  • Patients with clinically manifest infections or inflammation, surgery, trauma or hospitalization in the last 30 days
  • Chronic non-hepatic degenerative diseases (sclerosis, Parkinson's disease or -Alzheimer's disease)
  • Patients who do not participate in all stages of the research.

Sites / Locations

  • Faculty of PharmacyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cilostazol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Hepatic transaminases
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
Serum ferritin
Serum ferritin

Secondary Outcome Measures

Lipid profile
Total cholesterol (mg/dL), LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL), VLDL-cholesterol (mg/dL) and triglycerides (mg/dL) will be measured before and after the intervention.
Glycated haemoglobin
Hb A1c (%)
Serum stem cell transforming factor beta
Serum stem cell transforming factor beta
Adverse effects
Adverse effects
FAM19A5 serum level
FAM19A5 serum level

Full Information

First Posted
February 16, 2021
Last Updated
January 16, 2023
Sponsor
Sadat City University
search

1. Study Identification

Unique Protocol Identification Number
NCT04761848
Brief Title
Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease
Official Title
Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease: A Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sadat City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the current study is to evaluate the safety and efficay of cilostazol in treatment of patients with fatty liver disease. Several previous reports have shown that cilostazol ameliorates lipid imbalances in NAFLD. Cilostazol appeared to exert beneficial effects against NAFLD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Nonalcoholic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cilostazol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cilostazol 50 MG
Intervention Description
Cilostazol 50 MG tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet twice daily
Primary Outcome Measure Information:
Title
Hepatic transaminases
Description
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
Time Frame
week 12
Title
Serum ferritin
Description
Serum ferritin
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Lipid profile
Description
Total cholesterol (mg/dL), LDL-cholesterol (mg/dL), HDL-cholesterol (mg/dL), VLDL-cholesterol (mg/dL) and triglycerides (mg/dL) will be measured before and after the intervention.
Time Frame
week 12
Title
Glycated haemoglobin
Description
Hb A1c (%)
Time Frame
week 12
Title
Serum stem cell transforming factor beta
Description
Serum stem cell transforming factor beta
Time Frame
12 weeks
Title
Adverse effects
Description
Adverse effects
Time Frame
12 weeks
Title
FAM19A5 serum level
Description
FAM19A5 serum level
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults between 18 and 60 years of age, both men and women, Clinical diagnosis of NAFLD, confirmed by imaging exams, Patients who present levels above the reference values of ALT, AST and ferritin. Exclusion Criteria: Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation. Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification) Patients with schistosomiasis; Hemochromatosis Wilson's disease Viral or autoimmune hepatitis HIV virus carriers Woman who is breastfeeding Users of illicit drugs Patients with an intake of more than 20 g / day of alcohol and / or past alcoholism with abstention less than 6 months; Patients with ingestion of medications such as steroids, estrogens, amiodarone, warfarin, anti-convulsants, antipsychotics, tamoxifen or other chemotherapeutic agents in the last 6 months Patients with clinically manifest infections or inflammation, surgery, trauma or hospitalization in the last 30 days Chronic non-hepatic degenerative diseases (sclerosis, Parkinson's disease or -Alzheimer's disease) Patients who do not participate in all stages of the research.
Facility Information:
Facility Name
Faculty of Pharmacy
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abdallah, PhD
Phone
01063340887
Email
Mahmoud.samy@fop.usc.edu.eg
Phone
+201063340887
Email
Mahmoud.samy@fop.usc.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease

We'll reach out to this number within 24 hrs