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Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy

Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03961087
Acronym
EH
Enrollment
300
Registered
2019-05-23
Start date
2019-05-23
Completion date
2020-02-01
Last updated
2019-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coenzyme Q10, Hepatic Encephalopathy, Intellectual Functioning Disability

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.

Interventions

DRUGCoenzyme Q10

Coenzyme Q10 will be given twice

DRUGMECLOFENOXATE

MECLOFENOXATE will be given as 500 mg once daily.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

patients with liver cirrhosis and frequent hepatic encephalopathy (HE)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
hepatic encephalopathy6 monthsChange in the number of episodes
health related quality of life6 monthshealth related quality of life questionnaire
hepatic detoxifying function6 monthsreduction of serum ammonia

Countries

Egypt

Contacts

Primary ContactAmr S Hanafy, M.D.
DR_AMR_HANAFY@YAHOO.COM+201100061861

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026