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

NCT ID: NCT00740142

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-10-31

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

Conditions

Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Interventional arm: oral L-ornithine-L-aspartate and oral lactulose

Group Type: ACTIVE_COMPARATOR

L-ornithine-L-aspartate and lactulose

Intervention Type: DRUG

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

2

Oral lactulose

Group Type: PLACEBO_COMPARATOR

placebo and lactulose

Intervention Type: DRUG

placebo 3 times a day for 7 days

Interventions

L-ornithine-L-aspartate and lactulose

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

Intervention Type: DRUG

placebo and lactulose

placebo 3 times a day for 7 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siwaporn Chainuvati, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

Si 341/2008

Identifier Type: -

Identifier Source: org_study_id