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NCT02173132 Clinical Trial

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

Work Ability Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02173132
Other study ID # 1/2010
Secondary ID
Status Completed
Phase Phase 3
First received June 23, 2014
Last updated June 23, 2014
Start date April 2010

Study information
Verified date June 2014
Source University of Catania
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 94
Est. completion date
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 33 Years to 68 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Acetyl-L-carnitine

Other:
• Placebo

Locations
Country Name City State
Italy University of Catania Catania

Sponsors (1)
Lead Sponsor Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary work stress 90 days No
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