Clinical Trial: Complex Imaging Assessment of Steatosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Complex Imaging Assessment of Steatosis in Patients Under Treatment With Combination Silimarin, Phyllanthus Niruri and Choline
Brief Summary: The main objective is the assessment of MRI (Magnetic Resonance Imaging) Spectroscopy in patients diagnosed with hepatic steatosis in treatment with combination Silimarin, Phyllanthus Niruri and Choline.
Detailed Summary: In the study will be included patients with alcoholic and non-alcoholic steatohepatitis evaluated in Research Center of Gastroenterology and Hepatology and Gastroenterology Clinic of University of Medicine and Pharmacy of Craiova. All the patients will undergo MRI and MRI Spectroscopy (3 Tesla) using PHILIPS INGENIA 3T System for exact steatosis quantification. The eligible patients will be treated with combination Silimarin, Phyllanthus Niruri and Choline (Stoptoxin Forte) for 6 months (in conformity Product Characteristics). After the treatment a new IRM Spectroscopy examination will be performed. All the acquired data will be analyzed and published.
Sponsor: University of Medicine and Pharmacy Craiova
Current Primary Outcome: Fat-fraction [ Time Frame: 6 months after specific treatment ]
MRI Spectroscopy is the most direct non-invasive MR-based method to separate the liver signal into its water and fat components and calculate a signal fat-fraction.
To calculate the fat fraction record the area of lipid peak, the area of the water peak and the fat fraction is lipid area/(lipid area+ water area)×100.
The signal fat-fraction with MRI Spectroscopy has a dynamic range of 0-100%. Steatosis grades are categorized into broad brackets of severity: grade 0 (normal) = up to 5% of cells affected, grade 1 (mild) = 5-33% of cells affected, grade 2 (moderate) = 34-66% of cells affected, and grade 3 (severe) ≥67% of cells affected.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Medicine and Pharmacy Craiova
Dates:
Date Received: January 23, 2016
Date Started: January 2016
Date Completion: December 2016
Last Updated: January 27, 2016
Last Verified: January 2016
