Clinical trial NCT03961087: Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy
Official title: Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatic Encephalopathy
Coenzyme Q10
Intellectual Functioning Disability
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-05-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients with liver cirrhosis and frequent hepatic encephalopathy (HE)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: hepatic encephalopathy
timeFrame: 6 months
measure: health related quality of life
timeFrame: 6 months
measure: hepatic detoxifying function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Amr Shaaban Hanafy
state: Alsharkia
Study officials:
affiliation: Assistant prof of medicine-Zagazig University
name: Amr S Hanafy, M.D
role: PRINCIPAL_INVESTIGATOR
References: