Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy
This study has been completed.
Sponsor:
University of Catania
Information provided by:
University of Catania
ClinicalTrials.gov Identifier:
NCT01223742
First received: October 18, 2010
Last updated: NA
Last verified: December 2000
History: No changes posted
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Purpose
The aim of this study was to evaluate the effect of exogenous ALC on the both physical and mental fatigue in mild and moderate encephalopatic patients.
| Condition | Intervention |
|---|---|
|
Hepatic Encephalopathy |
Dietary Supplement: ACETYL-L-CARNITINE Drug: placebo |
| Study Type: | Interventional |
| Official Title: | ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY |
Resource links provided by NLM:
Further study details as provided by University of Catania:
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ACETYL-L-CARNITINE |
Dietary Supplement: ACETYL-L-CARNITINE
2 g acetylcarnitine taken orally twice a day.
|
| Placebo Comparator: placebo |
Drug: placebo
placebo twice per day
|
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- 1) Chronic hepatitis with spontaneous manifest HE (mental state grade 1 or 2 according to the West Haven criteria) and an NCT-A performance time >30 seconds;
- 2) Hyperammonemia (venous ammonia concentration >50 mmol/L);
- 3) Cooperative, hospitalised, adult patients with liver cirrhosis diagnosed by clinical, histological and ultrasonographic findings (reduced dimensions of the liver as well as splenomegaly) and oesophageal varices at stage II and III observed by endoscopy.
Exclusion Criteria:
- 1) Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis;
- 2) Acute superimposed liver injury;
- 3) Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease;
- 4) Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE;
- 5) Severe HE;
- 6) Administration of anti-HE medications such as neomycin, branched-chain amino acids;
- 7) Any additional precipitating factors such as high protein intake (additional high-protein meals), constipation or intake of psycho stimulants, sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil), beta-adrenergic blockers, neuromuscular blocking agents, certain antibiotics;
- 8) Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature;
- 9) Illiteracy.
Contacts and Locations
More Information
No publications provided by University of Catania
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01223742 History of Changes |
| Other Study ID Numbers: | 8-12-00 B |
| Study First Received: | October 18, 2010 |
| Last Updated: | October 18, 2010 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Hepatic Encephalopathy Brain Damage, Chronic Delirium Encephalitis Neurotoxicity Syndromes Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolic Diseases Confusion |
Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Poisoning Substance-Related Disorders Acetylcarnitine Carnitine Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013