Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability
NCT ID: NCT01957319
Last Updated: 2013-10-08
Study Results
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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COMPLETED
PHASE3
72 participants
INTERVENTIONAL
2010-02-28
2013-07-31
Brief Summary
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Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.
Patients and Methods: In this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (Group A) with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Silybin - vitamin E - phospholipids complex
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months.
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg
placebo
sugar pill
sugar pill
Interventions
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Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg
sugar pill
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
65 Years
ALL
No
Sponsors
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University of Catania
OTHER
Responsible Party
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Mariano Malaguarnera
Associate Professor
Locations
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University of Catania, Cannizzaro Hospital
Catania, , Italy
Countries
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References
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Malaguarnera G, Bertino G, Chisari G, Motta M, Vecchio M, Vacante M, Caraci F, Greco C, Drago F, Nunnari G, Malaguarnera M. Silybin supplementation during HCV therapy with pegylated interferon-alpha plus ribavirin reduces depression and anxiety and increases work ability. BMC Psychiatry. 2016 Nov 15;16(1):398. doi: 10.1186/s12888-016-1115-z.
Other Identifiers
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12/1997
Identifier Type: -
Identifier Source: org_study_id