Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease
Phase 1
Active, not recruiting
- Conditions
- Fatty Liver, Nonalcoholic
- Interventions
- Drug: Placebo
- Registration Number
- NCT04761848
- Lead Sponsor
- Sadat City University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cilostazol Cilostazol 50 MG - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Hepatic transaminases week 12 Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
Serum ferritin week 12 Serum ferritin
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Faculty of Pharmacy
🇪🇬Shibīn Al Kawm, Menoufia, Egypt