Complex Imaging Assessment of Steatosis

Fatty Liver Clinical Trial

— SteatoSPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02669641
• Other study ID #: SteatoSPC
• Secondary ID: 1334/17.12.2015
• Status: Recruiting
• Phase: Phase 4
• First received: January 23, 2016
• Last updated: January 27, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: University of Medicine and Pharmacy Craiova
• Contact: Ioana Andreea Gheonea, Lecturer
• Phone: +40751268732
• Email: iagheonea[@]gmail.com
• Is FDA regulated: No
• Health authority: Romania: National Authority for Scientific Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• steatosis described on abdominal ultrasound

Exclusion Criteria:

• chronic viral hepatitis

• liver cancer

• abusive alcohol consumption

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver

Intervention

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.

Locations

Country	Name	City	State
Romania	Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Romania	Craiova	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy Craiova	Fiterman Pharma SRL

Country where clinical trial is conducted

Romania, 

References & Publications (3)

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. — View Citation

Gheonea DI, Saftoiu A, Ciurea T, Gorunescu F, Iordache S, Popescu GL, Belciug S, Gorunescu M, Sandulescu L. Real-time sono-elastography in the diagnosis of diffuse liver diseases. World J Gastroenterol. 2010 Apr 14;16(14):1720-6. — View Citation

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). pii: E1. doi: 10.3390/biom6010001. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat-fraction	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.	6 months after specific treatment	No

External Links

•   The official website