Cilostazol in the Treatment of Nonalcoholic Fatty Liver Disease

NCT ID: NCT07238985

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2026-11-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Standard therapy

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Standard therapy

Intervention Type: 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).

Cilostazol

Intervention Type: 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

Interventions

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).

Intervention Type: OTHER

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mostafa Bahaa

Damietta, New Damietta, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mostafa Bahaa, PhD

Role: primary

mbahaa@horus.edu.eg

0201025538337

Other Identifiers

74596

Identifier Type: -

Identifier Source: org_study_id