Complex Imaging Assessment of Steatosis

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02669641

Acronym

SteatoSPC

Enrollment

Registered

2016-02-01

Start date

2016-01-31

Completion date

2016-12-31

Last updated

2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

Steatosis, Fatty liver, Steatohepatitis

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.

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.

Interventions

DIETARY_SUPPLEMENTCombination 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* steatosis described on abdominal ultrasound

Exclusion criteria

* chronic viral hepatitis * liver cancer * abusive alcohol consumption

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Romania

Contacts

Primary ContactIoana Andreea Gheonea, Lecturer

iagheonea@gmail.com+40751268732

Backup ContactDan Ionut Gheonea, Assoc. Prof.

digheonea@gmail.com+40751268731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026