SteatoSPC: Complex Imaging Assessment of Steatosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Steatosis Patients with diagnosed steatosis in treatment with combination Silimarin, Phyllanthus Niruri and Choline |
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:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- steatosis described on abdominal ultrasound
Exclusion Criteria:
-
chronic viral hepatitis
-
liver cancer
-
abusive alcohol consumption
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Romania | Craiova | Please Select | Romania | 200349 |
Sponsors and Collaborators
- University of Medicine and Pharmacy Craiova
- Fiterman Pharma SRL
Investigators
- Study Director: Ioana Andreea Gheonea, Lecturer, University of Medicine and Pharmacy Craiova
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Bannas P, Kramer H, Hernando D, Agni R, Cunningham AM, Mandal R, Motosugi U, Sharma SD, Munoz del Rio A, Fernandez L, Reeder SB. Quantitative magnetic resonance imaging of hepatic steatosis: Validation in ex vivo human livers. Hepatology. 2015 Nov;62(5):1444-55. doi: 10.1002/hep.28012. Epub 2015 Sep 28.
- Gheonea DI, Săftoiu A, Ciurea T, Gorunescu F, Iordache S, Popescu GL, Belciug S, Gorunescu M, Săndulescu L. Real-time sono-elastography in the diagnosis of diffuse liver diseases. World J Gastroenterol. 2010 Apr 14;16(14):1720-6.
- Kirpich IA, Miller ME, Cave MC, Joshi-Barve S, McClain CJ. Alcoholic Liver Disease: Update on the Role of Dietary Fat. Biomolecules. 2016 Jan 6;6(1):1. doi: 10.3390/biom6010001. Review.
- SteatoSPC
- 1334/17.12.2015