Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 23, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedJune 24, 2014
June 1, 2014
3.6 years
June 23, 2014
June 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
work stress
90 days
Study Arms (2)
acetyl-L-carnitine
ACTIVE COMPARATOR2 g acetyl-L carnitine twice a day for 90 days
sugar pill
PLACEBO COMPARATORPlacebo twice a day for 90 days
Interventions
Eligibility Criteria
You may qualify if:
- overt hepatic encephalopathy (HE) or a history of overt HE
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Catania
Catania, 95126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 23, 2014
First Posted
June 24, 2014
Study Start
April 1, 2010
Primary Completion
November 1, 2013
Last Updated
June 24, 2014
Record last verified: 2014-06