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Recruiting NCT07238985

Cilostazol in the Treatment of Nonalcoholic Fatty Liver Disease

Phase I / Phase II Interventional Fatty Liver

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard therapy, Cilostazol.
Who it may be relevant to
Registry conditions: Fatty Liver. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating the Safety and Efficacy of Cilostazol in the Treatment of Nonalcoholic Fatty Liver Disease Patients.

Overview

Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries (1). NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. NAFLD is characterized by excessive hepatic fat accumulation without other recognized causes of increased fat content (e.g., alcohol, virus, drugs, and autoimmunity). According to the Clinical Practice Guidelines of the European Association for the Study of the Liver, the diagnosis of NAFLD requires the exclusion of daily alcohol consumption \>30 g for men and \>20 g for women

Interventions

  • Other Standard therapy
    • The standard conventional therapy in both groups included regular exercise in the form of any physical activity as walking, cycling, etc. for 30-45 minutes minimum 5 days per week in addition to calorie restriction in overweight and obese patients (1200-1500 and 1000-1200 kcal/day for men and women, respectively).
  • Drug Cilostazol
    Cilostazol is a 2-hydroxyquinolone derivative and a drug approved for improving the claudication distance. Other studies have shown that Cilostazol can ameliorate hepatic steatosis, but the specific mechanism is still unknown

Primary outcome measures

  • The change in the degree of steatosis in the ultra sound and the change in fibrosis risk scores are the primary endpoint. [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).

Exclusion criteria

Pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake > 30 g per day in men and > 20 g per day in women).

Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis.

Patients suffering from chronic kidney disease, hyper/hypoparathyroidism, and congestive heart failure patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Mostafa Bahaa — Damietta

Identifiers

NCT: NCT07238985 · 74596

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗