Complex Imaging Assessment of Steatosis (SteatoSPC)

University of Medicine and Pharmacy Craiova

Status and phase: Unknown; Phase 4

Conditions: Fatty Liver

Treatments: Dietary Supplement: Combination Silimarin, Phyllanthus niruri and Choline

Study type: Interventional

Funder types: Other

Identifiers

NCT02669641

SteatoSPC

1334/17.12.2015 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• steatosis described on abdominal ultrasound

Exclusion criteria

• chronic viral hepatitis
• liver cancer
• abusive alcohol consumption

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Steatosis

Experimental group

Description:

Patients with diagnosed steatosis in treatment with combination Silimarin, Phyllanthus Niruri and Choline

Treatment:

Dietary Supplement: Combination Silimarin, Phyllanthus niruri and Choline