Coenzyme Q10 and Meclofenoxate in Hepatic Encephalopathy

NCT03961087 | Unknown

• 1 other identifier: 5501
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy; Coenzyme Q10; Intellectual Functioning Disability

Outcome Measures

Primary Outcomes (3)

• hepatic encephalopathy

  Change in the number of episodes

  6 months

• health related quality of life

  health related quality of life questionnaire

  6 months

• hepatic detoxifying function

  reduction of serum ammonia

  6 months

Study Arms (2)

case group

ACTIVE COMPARATOR

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

Drug: Coenzyme Q10; Drug: MECLOFENOXATE

control group

NO INTERVENTION

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

Interventions

Coenzyme Q10 DRUG

Coenzyme Q10 will be given twice

Also known as: coQ10

case group

MECLOFENOXATE DRUG

MECLOFENOXATE will be given as 500 mg once daily.

Also known as: LUCIDREL

case group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Amr Shaaban Hanafy

Zagazig, Alsharkia, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy; Intellectual Disability

Interventions

coenzyme Q10; Meclofenoxate

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxyacetates; Glycolates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Amr S Hanafy, M.D

  Assistant prof of medicine-Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr S Hanafy, M.D.

CONTACT

+201100061861; DR_AMR_HANAFY@YAHOO.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: patients with liver cirrhosis and frequent hepatic encephalopathy (HE)

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: May 23, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

EG (1)