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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 February 2016
Main ID:  NCT02669641
Date of registration: 23/01/2016
Prospective Registration: No
Primary sponsor: University of Medicine and Pharmacy Craiova
Public title: Complex Imaging Assessment of Steatosis SteatoSPC
Scientific title: Complex Imaging Assessment of Steatosis in Patients Under Treatment With Combination Silimarin, Phyllanthus Niruri and Choline
Date of first enrolment: January 2016
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02669641
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Romania
Contacts
Name:     Ioana Andreea Gheonea, Lecturer
Address: 
Telephone:
Email:
Affiliation:  University of Medicine and Pharmacy Craiova
Name:     Ioana Andreea Gheonea, Lecturer
Address: 
Telephone: +40751268732
Email: iagheonea@gmail.com
Affiliation: 
Name:     Ioana Andreea Gheonea, Lecturer
Address: 
Telephone: +40751268732
Email: iagheonea@gmail.com
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- steatosis described on abdominal ultrasound

Exclusion Criteria:

- chronic viral hepatitis

- liver cancer

- abusive alcohol consumption



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Fatty Liver
Intervention(s)
Dietary Supplement: Combination Silimarin, Phyllanthus niruri and Choline
Primary Outcome(s)
Fat-fraction [Time Frame: 6 months after specific treatment]
Secondary Outcome(s)
Secondary ID(s)
1334/17.12.2015
SteatoSPC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fiterman Pharma SRL
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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