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

University of Catania

Status and phase: Completed; Phase 3

Conditions: Work Performance; Work Stress; Work Ability

Treatments: Drug: Acetyl-L-carnitine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02173132

1/2010

Details and patient eligibility

About

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

Enrollment: 94 patients

Sex: All

Ages: 33 to 68 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

acetyl-L-carnitine

Active Comparator group

Description:

2 g acetyl-L carnitine twice a day for 90 days

Treatment:

Drug: Acetyl-L-carnitine

sugar pill

Placebo Comparator group

Description:

Placebo twice a day for 90 days

Treatment:

Other: Placebo