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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02973295 |
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Date of registration:
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04/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Silymarin in NAFLD
SINF |
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Scientific title:
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Silymarin® - Efficacy in Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) Controlled by Laboratory and and Elastographic Parameters |
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Date of first enrolment:
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September 20, 2019 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02973295 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Goran Hauser, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Hospital Centre Rijek, Croatia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- NAFLD patients
- signed informed consent
- possibility to follow instruction and the protocol
Exclusion Criteria:
- chronic B or C hepatitis
- usage of hepatotoxic drugs in the period of 6 months before inclusion
- chronic kidney insufficiency (grade 4 and 5), hemodialysis
- any other chronic liver disease
- opioid dependancy
- any malignancy
- HIV seropositivity
- alcohol abuse
- pregnancy
- inability to follow the protocol
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-Alcoholic Fatty Liver Disease
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Intervention(s)
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Drug: Silymarin
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Other: Placebo Oral Capsule
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Primary Outcome(s)
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Change (Reduction) of parameters of liver steatosis defined by CAP (Controlled Attenuation Parameter) and liver fibrosis defined by LSM (liver stiffness measurements) during the 6 months period
[Time Frame: 0 week (Initiation) and during 24-25 week (End of the Study)]
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Secondary Outcome(s)
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Change in lipidogram in period of 6 months
[Time Frame: 0 week (Initiation) and during 24-25 week (End of the Study)]
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Change in insulin resistance in period of 6 months
[Time Frame: 0 week (Initiation) and during 24-25 week (End of the Study)]
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Change in liver enzymes in period of 6 months
[Time Frame: 0 week (Initiation) and during 24-25 week (End of the Study)]
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Secondary ID(s)
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KBCRi/2016-GH01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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