Effects on quality of life of L-carnitine administration in covert hepatic encephalopathy

A randomized, multi-center, double-blinded, placebo controlled, investigator initiated trial to assess the impact on quality of life of L-carnitine administration in the liver cirrhosis due to chronic hepatitis B patients with Covert hepatic encephalopathy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002029

Enrollment

150

Registered

2016-08-26

Start date

2016-04-21

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Indication of study is liver cirrhosis due to chronic hepatitis B patients with Covert hepatic encephalopathy. The subject radomly allocate by one to one and each group take a double-blind. Exp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age : 19-65 years old 2. Hepatitis B associated cirrhosis 3. Covert hepatic encephalopathy (Minimal hepatic HE or West Heaven Grade I ) 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. History of overt hepatic encephalopathy (West Heave grade II or more) 2. History of psychiatric or neurologic disease 3. Malignant tumor (except well controlled hepatocellular carcinoma) 4. Viable hepatocelluar carcinoma 5. Recent upper gastrointestinal bleeding within 6 months 6. Immune suppressive agent medication 7. ALT > 400 IU/L 8. Serum creatinin > 1.5 mg/dl 9. Hypersensitivity to carnitine 10. Significant alcohol consumption ( male > 210 g/week, female> 140 g/week) 11. Women who want to pregnant 12. Pregnant women 13. Join recent another clinical trial within 1 month.

Design outcomes

Primary

Measure	Time frame
Life of quality	—

Secondary

Measure	Time frame
Covert hepatic encephalopathy;Liver function (The Model for End-Stage Liver Disease, Child score)	—

Countries

Korea, Republic of

Contacts

Public ContactHyo Kim

Hanyang University Seoul Hospital

Outcome results