Complex Imaging Assessment of Steatosis

NCT ID: NCT02669641

Last Updated: 2016-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Fatty Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Steatosis

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

Group Type EXPERIMENTAL

Combination Silimarin, Phyllanthus niruri and Choline

Intervention Type DIETARY_SUPPLEMENT

Combination of one capsule: Phyllanthus niruri (225 mg), Silybum marianum (150 mg), Choline (60 mg) The dose: 3 capsules per day.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Stoptoxin Forte

Eligibility Criteria

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Inclusion Criteria

* steatosis described on abdominal ultrasound

Exclusion Criteria

* chronic viral hepatitis
* liver cancer
* abusive alcohol consumption
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fiterman Pharma SRL

UNKNOWN

Sponsor Role collaborator

University of Medicine and Pharmacy Craiova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ioana Andreea Gheonea, Lecturer

Role: STUDY_DIRECTOR

University of Medicine and Pharmacy Craiova

Locations

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Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Romania

Craiova, Please Select, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Ioana Andreea Gheonea, Lecturer

Role: CONTACT

+40751268732

Dan Ionut Gheonea, Assoc. Prof.

Role: CONTACT

+40751268731

Facility Contacts

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Ioana Andreea Gheonea, Lecturer

Role: primary

+40751268732

Dan Ionut Gheonea, Assoc. Prof.

Role: backup

+40751268731

References

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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.

Reference Type BACKGROUND
PMID: 26751488 (View on PubMed)

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. doi: 10.3748/wjg.v16.i14.1720.

Reference Type BACKGROUND
PMID: 20380003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26224591 (View on PubMed)

Other Identifiers

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1334/17.12.2015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SteatoSPC

Identifier Type: -

Identifier Source: org_study_id

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