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

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740142
• Other study ID #: Si 341/2008
• Status: Completed
• Phase: Phase 4
• Start date: September 2008
• Est. completion date: October 2011

Study information

• Verified date: September 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• L-ornithine-L-aspartate and lactulose
L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days
• placebo and lactulose
placebo 3 times a day for 7 days

Locations

Country	Name	City	State
Thailand	Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess improvement of mental status of the patients		7 days
Secondary	To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients		7 days