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

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ClinicalTrials.gov Identifier: NCT04761848
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Mahmoud Samy Abdallah, 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

Condition or disease Intervention/treatment Phase
Fatty Liver, Nonalcoholic Drug: Cilostazol 50 MG Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease: A Randomized, Controlled Trial.
Actual Study Start Date : February 16, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
Drug Information available for: Cilostazol

Arm Intervention/treatment
Experimental: Cilostazol Drug: Cilostazol 50 MG
Cilostazol 50 MG tablet twice daily

Placebo Comparator: Placebo Drug: Placebo
Placebo tablet twice daily




Primary Outcome Measures :
  1. Hepatic transaminases [ Time Frame: week 12 ]
    Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L

  2. Serum ferritin [ Time Frame: week 12 ]
    Serum ferritin


Secondary Outcome Measures :
  1. Lipid profile [ Time Frame: 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.

  2. Glycated haemoglobin [ Time Frame: week 12 ]
    Hb A1c (%)

  3. Serum stem cell transforming factor beta [ Time Frame: 12 weeks ]
    Serum stem cell transforming factor beta

  4. Adverse effects [ Time Frame: 12 weeks ]
    Adverse effects

  5. FAM19A5 serum level [ Time Frame: 12 weeks ]
    FAM19A5 serum level



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761848


Locations
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Egypt
Faculty of Pharmacy Recruiting
Shibīn Al Kawm, Menoufia, Egypt, 13829
Contact: Mahmoud S Abdallah, PhD    01063340887    Mahmoud.samy@fop.usc.edu.eg   
Contact    +201063340887    Mahmoud.samy@fop.usc.edu.eg   
Sponsors and Collaborators
Sadat City University
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Responsible Party: Mahmoud Samy Abdallah, Lecturer of Clinical Pharmacy, Sadat City University
ClinicalTrials.gov Identifier: NCT04761848    
Other Study ID Numbers: 10/2021IRI
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors