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Complex Imaging Assessment of Steatosis (SteatoSPC)

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ClinicalTrials.gov Identifier: NCT02669641
Recruitment Status : Unknown
Verified January 2016 by University of Medicine and Pharmacy Craiova.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
Fiterman Pharma SRL
Information provided by (Responsible Party):
University of Medicine and Pharmacy Craiova

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
Fatty Liver Dietary Supplement: Combination Silimarin, Phyllanthus niruri and Choline 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complex Imaging Assessment of Steatosis in Patients Under Treatment With Combination Silimarin, Phyllanthus Niruri and Choline
Study Start Date : January 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016


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 Name: Stoptoxin Forte




Primary Outcome Measures :
  1. Fat-fraction [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • steatosis described on abdominal ultrasound

Exclusion Criteria:

  • chronic viral hepatitis
  • liver cancer
  • abusive alcohol consumption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669641


Contacts
Contact: Ioana Andreea Gheonea, Lecturer +40751268732 iagheonea@gmail.com
Contact: Dan Ionut Gheonea, Assoc. Prof. +40751268731 digheonea@gmail.com

Locations
Romania
Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Romania Recruiting
Craiova, Please Select, Romania, 200349
Contact: Ioana Andreea Gheonea, Lecturer    +40751268732    iagheonea@gmail.com   
Contact: Dan Ionut Gheonea, Assoc. Prof.    +40751268731    digheonea@gmail.com   
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

Additional Information:
Publications:
Responsible Party: University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier: NCT02669641     History of Changes
Other Study ID Numbers: SteatoSPC
1334/17.12.2015 ( Other Grant/Funding Number: UMF Craiova )
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Medicine and Pharmacy Craiova:
Steatosis, Fatty liver, Steatohepatitis

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Choline
Silymarin
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs