Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01559519 - Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy Phase 4
Terminated NCT01846806 - The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy. N/A
Recruiting NCT01178372 - Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis Phase 4
Completed NCT00914056 - A Study of Controlled Lactulose Withdrawal N/A
Completed NCT00740142 - Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy Phase 4
Completed NCT00558038 - Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy Phase 2
Completed NCT00986895 - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group Phase 1
Completed NCT00287235 - Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS) N/A
Recruiting NCT05539027 - Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy Phase 4
Recruiting NCT04096014 - Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy N/A
Completed NCT05526404 - Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration N/A
Completed NCT04082780 - Rifamycin in Minimal Hepatic Encephalopathy Phase 2
Enrolling by invitation NCT06367127 - Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Active, not recruiting NCT05425316 - Speech in Hepatic Encephalopathy (HE)
Recruiting NCT04415294 - Flicker App for Minimal Hepatic Encephalopathy
Not yet recruiting NCT06072521 - Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy Phase 2
Completed NCT02636647 - Fecal Transplant in Recurrent Hepatic Encephalopathy Phase 1
Withdrawn NCT02086825 - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure Phase 3
Completed NCT01446523 - S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE N/A
Completed NCT01218568 - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial N/A