Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

— EH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961087
• Other study ID #: 5501
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2019
• Source: Zagazig University
• Contact: Amr S Hanafy, M.D.
• Phone: +201100061861
• Email: DR_AMR_HANAFY[@]YAHOO.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Coenzyme Q10
• Hepatic Encephalopathy
• Intellectual Disability
• Intellectual Functioning Disability

Intervention

Drug:
• Coenzyme Q10
Coenzyme Q10 will be given twice
• MECLOFENOXATE
MECLOFENOXATE will be given as 500 mg once daily.

Locations

Country	Name	City	State
Egypt	Amr Shaaban Hanafy	Zagazig	Alsharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatic encephalopathy	Change in the number of episodes	6 months
Primary	health related quality of life	health related quality of life questionnaire	6 months
Primary	hepatic detoxifying function	reduction of serum ammonia	6 months