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CompletedNCT00740142Updated Sep 4, 2020

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

A Phase 4 interventional study of L-ornithine-L-aspartate and lactulose and placebo and lactulose in Hepatic Encephalopathy, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Hepatic Encephalopathy

Keywords

  • L ornithine L aspartate
  • Lactulose
  • Hepatic encephalopathy
  • LOLA
03

In context

Hepatic Encephalopathy

218 studies on the registry are indexed under Hepatic Encephalopathy; 48 are open to participants now.

This study's enrollment of 35 is below the median of 60 across 148 interventional studies indexed under Hepatic Encephalopathy.

Browse Hepatic Encephalopathy studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Active comparator
    1

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

    Drug: L-ornithine-L-aspartate and lactulose

  • Placebo comparator
    2

    Oral lactulose

    Drug: placebo and lactulose

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

06

What researchers measure

Primary outcomes

  1. To assess improvement of mental status of the patients

    Time frame: 7 days

Secondary outcomes

  1. To assess improvement of number connection test, serum ammonia, EEG, asterixis and PSE index of the patients

    Time frame: 7 days

07

Study locations

1 site
  • Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00740142
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Aug 22, 2008
Start date
Sep 2008
Primary completion
Aug 2010
Completion
Oct 2011
Last update
Sep 4, 2020

Study contacts

Siwaporn Chainuvati, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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