Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy

Phase 3

Completed

• Conditions: Work Stress; Work Ability; Work Performance
• Interventions: Other: Placebo; Drug: Acetyl-L-carnitine

• Registration Number: NCT02173132
• Lead Sponsor: University of Catania

Brief Summary

This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress, Work Ability and Work Performance in subjects with Hepatic Encephalopathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2013-11
• Status Verified: 2014-06
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-23
• Last Update Submitted: 2014-06-23
• Study First Posted: 2014-06-24
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• overt hepatic encephalopathy (HE) or a history of overt HE

Exclusion Criteria

• history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	Placebo	Placebo twice a day for 90 days
acetyl-L-carnitine	Acetyl-L-carnitine	2 g acetyl-L carnitine twice a day for 90 days

Primary Outcome Measures

Name	Time	Method
work stress	90 days

Trial Locations

Locations (1)

University of Catania; 🇮🇹 Catania, Italy