Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy

Efficacy of Combined Oral L-ornithine-L-aspartate and Oral Lactulose in Patients With Hepatic Encephalopathy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00740142

Enrollment

Registered

2008-08-22

Start date

2008-09-30

Completion date

2011-10-31

Last updated

2020-09-04

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

Conditions

Hepatic Encephalopathy

Keywords

L ornithine L aspartate, Lactulose, Hepatic encephalopathy, LOLA

Brief summary

Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial

Detailed description

Data collection 1. Baseline characteristics * demographic data; age, gender, BW, height * cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc. * comorbidity such as DM, CVA 2. After randomization * assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7 * blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7 * record adverse effect of drug such as nausea, vomiting, bloating. * record diet, frequency of bowel movement and stool pH * compliance

Interventions

DRUGL-ornithine-L-aspartate and lactulose

L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days

DRUGplacebo and lactulose

placebo 3 times a day for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Cirrhosis * Age 18-80 * Hepatic encephalopathy grade II-III * Serum ammonia \> 60 mcg/mL * Informed consent

Exclusion criteria

* Recent GI hemorrhage * Severe sepsis * Degenerative CNS disease or major psychiatric illness * Serum creatinine \> 1.5 mg/dl * Pregnancy or lactation * Poorly controlled DM * Insertion of TIPS * Received CNS depressants or hypnotics * Treatment with metronidazole, kanamycin or branched-chain amino acid * Hypersensitivity to L-ornithine-L-aspartate

Design outcomes

Primary

Measure	Time frame
To assess improvement of mental status of the patients	7 days

Secondary

Measure	Time frame
To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients	7 days

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026