Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability

Phase 3

Completed

• Conditions: Work Ability; Depression
• Interventions: Drug: sugar pill; Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg

• Registration Number: NCT01957319
• Lead Sponsor: University of Catania

Brief Summary

Background: Hepatitis C virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life.

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

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-09-30
• Last Update Submitted: 2013-09-30
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• HCV infection

Exclusion Criteria

• cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy hemoglobinopathies hemocromatosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	sugar pill	sugar pill
Silybin - vitamin E - phospholipids complex	Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg	Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months.

Primary Outcome Measures

Name	Time	Method
Work ability index	12 months	Administration of questionnaire(Work ability Index - WAI)The work ability index is a tool to record the work ability of employees. It aims at identifying, at an early stage, health risks of early retirement an counteracting them. The questionnaire is aimed at: 1) the estimated current and future work ability; 2) diagnosed illness and the number of absenteeism days in the previous year; 3) the estimated sickness-related deterioration in the work performance; 4) mental ability reserves. The WAI evaluates current work ability compared with lifetime and in relation to the demands of the job, number of current diseases diagnosed by a physician, estimated work impairment due to diseases.

Secondary Outcome Measures

Name	Time	Method
depression	12 months

Trial Locations

Locations (1)

University of Catania, Cannizzaro Hospital; 🇮🇹 Catania, Italy