NCT02669641

Complex Imaging Assessment of Steatosis

Complex Imaging Assessment of Steatosis in Patients Under Treatment With Combination Silimarin, Phyllanthus Niruri and Choline

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Medicine and Pharmacy Craiova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fatty Liver

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Combination Silimarin, Phyllanthus niruri and Choline	Combination of one capsule: Phyllanthus niruri (225 mg), Silybum marianum (150 mg), Choline (60 mg) The dose: 3 capsules per day.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2016-02-01
• Last updated: 2016-02-01

Locations

1 site across 1 country: Romania