Back to resultsAcetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy
Primary Purpose
Work Stress, Work Ability, Work Performance
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Acetyl-L-carnitine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Work Stress
Eligibility Criteria
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.
Sites / Locations
- University of Catania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
acetyl-L-carnitine
sugar pill
Arm Description
2 g acetyl-L carnitine twice a day for 90 days
Placebo twice a day for 90 days
Outcomes
Primary Outcome Measures
work stress
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02173132
Brief Title
Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work Stress, Work Ability, Work Performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acetyl-L-carnitine
Arm Type
Active Comparator
Arm Description
2 g acetyl-L carnitine twice a day for 90 days
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo twice a day for 90 days
Intervention Type
Drug
Intervention Name(s)
Acetyl-L-carnitine
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
work stress
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
33 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Catania
City
Catania
ZIP/Postal Code
95126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy
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