Work Ability Clinical Trial
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 |
Verified date | June 2014 |
Source | University of Catania |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
This study evaluated the effects of acetyl-L-carnitine treatment on Perceived Work Stress, Work Ability and Work Performance in subjects with Hepatic Encephalopathy.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University of Catania | Catania |
Lead Sponsor | Collaborator |
---|---|
University of Catania |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | work stress | 90 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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