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

September 2, 2020 updated by: Mahidol University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Interventional arm: oral L-ornithine-L-aspartate and oral lactulose
Drug: L-ornithine-L-aspartate and lactulose
L-ornithine-L-aspartate 1 sachet(3 grams)3 times a day for 7 days
Placebo Comparator: 2
Oral lactulose
Drug: placebo and lactulose
placebo 3 times a day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess improvement of mental status of the patients
Time Frame: 7 days
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Siwaporn Chainuvati, MD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Actual)

September 4, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 341/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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