Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy (EH)

Zagazig University

Status: Unknown

Conditions: Hepatic Encephalopathy; Coenzyme Q10; Intellectual Functioning Disability

Treatments: Drug: Coenzyme Q10; Drug: MECLOFENOXATE

Study type: Interventional

Funder types: Other

Identifiers

NCT03961087

5501

Details and patient eligibility

About

Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness.

Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.

Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.

Full description

Hepatic encephalopathy is a syndrome occurs in patients with liver cirrhosis and is defined as neuropsychiatric abnormalities in patients with liver impairment, characterized by personality changes, intellectual impairment, and an impaired level of consciousness. Hepatic encephalopathy is categorized into Type A hepatic encephalopathy associated with acute liver failure; Type B hepatic encephalopathy is associated with portal-systemic bypass and no intrinsic hepatocellular disease; Type C hepatic encephalopathy describes encephalopathy associated with Cirrhosis and portal hypertension; type C hepatic encephalopathy is, in turn, subcategorized as episodic, persistent, or minimal.

A number of theories had been postulated, it was proposed that hepatic encephalopathy is a disorder of astrocyte function which play a key role in the regulation of the blood-brain barrier, maintaining electrolyte homeostasis , a role in the detoxification of chemicals, including ammonia.

neurotoxic substances, including ammonia and manganese cause morphologic changes in the astrocytes leading to Alzheimer type II astrocytosis in cirrhosis.

Hepatic encephalopathy may be due to accumulated neurotoxic substances in the brain as short-chain fatty acids; mercaptans; false neurotransmitters, such as tyramine, octopamine, and beta-phenylethanolamines; manganese; ammonia; and gamma-aminobutyric acid (GABA).

Coenzyme Q10 (CoQ10) is a necessary cofactor of the mitochondrial metabolism. It provides a High antioxidant and protective effects on age-related morbidities such as hypertension, heart failure and neurodegenerative diseases and hepatoprotective effects in drug related hepatic impairment.

Meclofenoxate is a cholinergic nootropic drug used clinically to improve memory, mental function and general cognition.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All the patients diagnosed as having liver cirrhosis Exclusion Criteria
• recent alcohol intake;
• Infection, recent antibiotic use or gastrointestinal bleeding;
• use of drugs affecting psychometric Performances like benzodiazepines, antiepileptics, psychotropic drugs
• History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension;
• Electrolyte abnormalities
• Renal impairment or hepatorenal syndrome
• hepatocellular carcinoma;
• Severe medical co-morbidities that affect quality-of-life measurement as heart failure pulmonary or neurological insults.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

case group

Active Comparator group

Description:

patients with liver cirrhosis and frequent hepatic encephalopathy received coenzyme Q10 and Meclofenoxate in addition to usual hepatic support

Treatment:

Drug: MECLOFENOXATE

Drug: Coenzyme Q10

control group

No Intervention group

Description:

patients with liver cirrhosis and frequent hepatic encephalopathy received usual hepatic support only