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

Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease: A Randomized, Controlled Trial.

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

Study Overview

• Status: Withdrawn
• Conditions: Fatty Liver, Nonalcoholic
• Intervention / Treatment: Drug: Placebo; Drug: Cilostazol 50 MG

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 13829
      • Faculty of pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablet twice daily
Experimental: Cilostazol	Drug: Cilostazol 50 MG; Cilostazol 50 MG tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic transaminases	Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L	week 12
Serum ferritin	Serum ferritin	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 12
Glycated haemoglobin	Hb A1c (%)	week 12
Serum stem cell transforming factor beta	Serum stem cell transforming factor beta	12 weeks
Adverse effects	Adverse effects	12 weeks
FAM19A5 serum level	FAM19A5 serum level	12 weeks

Collaborators and Investigators

• Sponsor: Sadat City University

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Protective Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Vasodilator Agents; Neuroprotective Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: 10/2021IRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No