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

NCT04761848 | Withdrawn Phase 1

• 1 other identifier: 10/2021IRI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Fatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (2)

• Hepatic transaminases

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

  week 12

• Serum ferritin

  Serum ferritin

  week 12

Secondary Outcomes (5)

• Lipid profile

  week 12

• Glycated haemoglobin

  week 12

• Serum stem cell transforming factor beta

  12 weeks

• Adverse effects

  12 weeks

• FAM19A5 serum level

  12 weeks

Study Arms (2)

Cilostazol

EXPERIMENTAL

Drug: Cilostazol 50 MG

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cilostazol 50 MG DRUG

Cilostazol 50 MG tablet twice daily

Cilostazol

Placebo DRUG

Placebo tablet twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Pharmacy

Shibīn al Kawm, Menoufia, 13829, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: February 16, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)