NCT02669641

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

January 23, 2016

Last Update Submit

January 27, 2016

Conditions

Fatty Liver

Keywords

Steatosis, Fatty liver, Steatohepatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Steatosis

EXPERIMENTAL

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

Dietary Supplement: Combination Silimarin, Phyllanthus niruri and Choline

Interventions

Combination Silimarin, Phyllanthus niruri and CholineDIETARY_SUPPLEMENT

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

Also known as: Stoptoxin Forte
Steatosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • steatosis described on abdominal ultrasound

You may not qualify if:

  • chronic viral hepatitis
  • liver cancer
  • abusive alcohol consumption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Craiova, Please Select, 200349, Romania

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26751488BACKGROUND

  • 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.

    PMID: 20380003BACKGROUND

  • 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.

    PMID: 26224591BACKGROUND

MeSH Terms

Conditions

Fatty Liver

Interventions

Choline

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Study Officials

  • Ioana Andreea Gheonea, Lecturer

    University of Medicine and Pharmacy Craiova

    STUDY DIRECTOR

Central Study Contacts

Ioana Andreea Gheonea, Lecturer

CONTACT

+40751268732iagheonea@gmail.com

Dan Ionut Gheonea, Assoc. Prof.

CONTACT

+40751268731digheonea@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2016

First Posted

February 1, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

RO(1)