Hepatic Encephalopathy Clinical Trial
— EHOfficial title:
Impact of Coenzyme Q10 and Meclofenoxate on Frequency and Severity of Hepatic Encephalopathy
NCT number | NCT03961087 |
Other study ID # | 5501 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2019 |
Est. completion date | February 1, 2020 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Amr Shaaban Hanafy | Zagazig | Alsharkia |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
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 |
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