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

Fatty Liver, Nonalcoholic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04761848
• Other study ID #: 10/2021IRI
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 16, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Sadat City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Cilostazol 50 MG
Cilostazol 50 MG tablet twice daily
• Placebo
Placebo tablet twice daily

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic transaminases	Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L	week 12
Primary	Serum ferritin	Serum ferritin	week 12
Secondary	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
Secondary	Glycated haemoglobin	Hb A1c (%)	week 12
Secondary	Serum stem cell transforming factor beta	Serum stem cell transforming factor beta	12 weeks
Secondary	Adverse effects	Adverse effects	12 weeks
Secondary	FAM19A5 serum level	FAM19A5 serum level	12 weeks