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

NCT ID: NCT04761848

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cilostazol

Group Type: EXPERIMENTAL

Cilostazol 50 MG

Intervention Type: DRUG

Cilostazol 50 MG tablet twice daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet twice daily

Interventions

Cilostazol 50 MG

Cilostazol 50 MG tablet twice daily

Intervention Type: DRUG

Placebo

Placebo tablet twice daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sadat City University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Samy Abdallah

Lecturer of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Pharmacy

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

Other Identifiers

10/2021IRI

Identifier Type: -

Identifier Source: org_study_id