Status:
COMPLETED
Efficacy of Phosphatidylcholine in NAFLD
Lead Sponsor:
Nehal Abou Seada
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study evaluates efficacy of Phosphatidylcholine in addition to life style modification and patient health education by clinical Pharmacist in the Management of Non Alcoholic Fatty Liver NAFLD. Al...
Detailed Description
As a result of increasing rates of obesity Non Alcoholic Fatty Liver (NAFLD) is the most common liver disorder affecting 17-46% of adults and parallels the prevalence of Metabolic Syndrome (MetS) and ...
Eligibility Criteria
Inclusion
- Patients were included in the study when the following criteria to were fulfilled :
- fatty liver upon Ultrasonography (US) /Computed Tomography (CT) /Magnetic Resonance Imaging (MRI) with either incidental increased Alanine Aminotransferase (ALT)
- the presence of risk factors related to NAFLD + increased ALT
- symptomatic liver disease +/- hepatomegaly, +/- increased ALT
- homeostasis model assessment-insulin resistance HOMA IR score \> 3
- presence of liver steatosis or stiffness measured by transient elastography
- eligible patients had at least one of the following metabolic comorbidities: hypertension, Type 2 Diabetes Mellitus, overweight/obesity (BMI\>27 kg/m2) serum cholesterol of \> 200 mg/d
- Patients were excluded from the study if showing evidence :
Exclusion
- if showing evidence of alcoholic or chronic liver disease
- Hepatocellular Carcinoma, autoimmune hepatitis
- end stage liver disease
- treatment with other hepatoprotectants
- other concomitant EPL within 30 days of study initiation
- pregnancy or lactation
Key Trial Info
Start Date :
January 2 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04411862
Start Date
January 2 2016
End Date
July 1 2019
Last Update
June 4 2020
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