Cilostazol in the Treatment of Nonalcoholic Fatty Liver Disease

NCT07238985 | Recruiting Phase 1

• 1 other identifier: 74596
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (1)

• The change in the degree of steatosis in the ultra sound and the change in fibrosis risk scores are the primary endpoint.

  The change in the degree of steatosis in the ultra sound and the change in fibrosis risk scores are the primary endpoint.

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

25 patients received the standard conventional therapy in addition to placebo for 3 months.

Other: Standard therapy

Cilostazole group

ACTIVE COMPARATOR

25 patients were given the standard conventional therapy plus cilostazol 100 mg two times daily.

Other: Standard therapy; Drug: Cilostazol

Interventions

Standard therapy OTHER

• 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).

Cilostazole group; Control group

Cilostazol DRUG

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

Cilostazole group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Mostafa Bahaa

Damietta, New Damietta, 34518, Egypt

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Interventions

Standard of Care; Cilostazol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

EG (1)