Complex Imaging Assessment of Steatosis

Phase 4

• Conditions: Fatty Liver
• Interventions: Dietary Supplement: Combination Silimarin, Phyllanthus niruri and Choline

• Registration Number: NCT02669641
• Lead Sponsor: University of Medicine and Pharmacy Craiova

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 Description

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.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-23
• Study First Submitted QC: 2016-01-27
• Last Update Submitted: 2016-01-27
• Study First Posted: 2016-02-01
• Last Update Posted: 2016-02-01
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• steatosis described on abdominal ultrasound

Exclusion Criteria

• chronic viral hepatitis
• liver cancer
• abusive alcohol consumption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Steatosis	Combination Silimarin, Phyllanthus niruri and Choline	Patients with diagnosed steatosis in treatment with combination Silimarin, Phyllanthus Niruri and Choline

Primary Outcome Measures

Name	Time	Method
Fat-fraction	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.

Trial Locations

Locations (1)

Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Romania; 🇷🇴 Craiova, Please Select, Romania