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
|Condition or disease||Intervention/treatment||Phase|
|Fatty Liver||Dietary Supplement: Combination Silimarin, Phyllanthus niruri and Choline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Contact: Ioana Andreea Gheonea, Lecturerfirstname.lastname@example.org|
|Contact: Dan Ionut Gheonea, Assoc. Prof.||+email@example.com|
|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 firstname.lastname@example.org|
|Contact: Dan Ionut Gheonea, Assoc. Prof. +40751268731 email@example.com|
|Study Director:||Ioana Andreea Gheonea, Lecturer||University of Medicine and Pharmacy Craiova|