Trial | NCT02669641  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
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 Started
Jan 31
2016
Primary Completion
Jun 30
2016
Anticipated
Study Completion
Dec 31
2016
Anticipated
Last Update
Feb 01
2016
Estimate

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.

  • Other names: Stoptoxin Forte

Steatosis Experimental

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

Criteria 

Inclusion Criteria:

steatosis described on abdominal ultrasound

Exclusion Criteria:

chronic viral hepatitis
liver cancer
abusive alcohol consumption
No Results Posted