Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy

NCT ID: NCT03961087

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-23
• Study Completion Date: 2020-02-01

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.

Conditions

Hepatic Encephalopathy; Coenzyme Q10; Intellectual Functioning Disability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

case group

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

Group Type: ACTIVE_COMPARATOR

Coenzyme Q10

Intervention Type: DRUG

Coenzyme Q10 will be given twice

MECLOFENOXATE

Intervention Type: DRUG

MECLOFENOXATE will be given as 500 mg once daily.

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coenzyme Q10

Coenzyme Q10 will be given twice

Intervention Type: DRUG

MECLOFENOXATE

MECLOFENOXATE will be given as 500 mg once daily.

Intervention Type: DRUG

Other Intervention Names

coQ10; LUCIDREL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Amr Shaaban Hanafy

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr S Hanafy, M.D

Role: PRINCIPAL_INVESTIGATOR

Assistant prof of medicine-Zagazig University

Locations

Amr Shaaban Hanafy

Zagazig, Alsharkia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amr S Hanafy, M.D.

Role: CONTACT

DR_AMR_HANAFY@YAHOO.COM

+201100061861

Other Identifiers

5501

Identifier Type: -

Identifier Source: org_study_id