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

NCT04761848 — Phase 1 / Phase 2, Withdrawn, Sadat City University

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

Registry	NCT04761848
Status	Withdrawn - Institutional and funding constrains
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Sponsor	Sadat City University (Other)
Conditions	Fatty Liver, Nonalcoholic
Interventions	Cilostazol 50 MG, Placebo (Drug)
Dates	start 2021-02-16, primary completion 2024-10-31 (estimated), completion 2024-12-31 (estimated), first posted 2021-02-21, last updated 2025-07-14
Locations	1 site in Egypt

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Cilostazol	Experimental	Drug: Cilostazol 50 MG
Placebo	Placebo comparator	Drug: Placebo

Cilostazol 50 MG (Drug): Cilostazol 50 MG tablet twice daily
Placebo (Drug): Placebo tablet twice daily

+Outcome measures

Primary outcomes

Hepatic transaminases [week 12]: Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
Serum ferritin [week 12]: Serum ferritin

Secondary outcomes

Lipid profile [week 12]: 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 [week 12]: Hb A1c (%)
Serum stem cell transforming factor beta [12 weeks]: Serum stem cell transforming factor beta
Adverse effects [12 weeks]: Adverse effects
FAM19A5 serum level [12 weeks]: FAM19A5 serum level

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
Faculty of Pharmacy	Shibīn al Kawm, Menoufia	Egypt