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

Primary Purpose

Hepatic Encephalopathy

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

L-ornithine-L-aspartate and lactulose

placebo and lactulose

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring L ornithine L aspartate, Lactulose, Hepatic encephalopathy, LOLA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

Oral lactulose

Outcomes

Primary Outcome Measures

To assess improvement of mental status of the patients

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00740142

First Posted

August 21, 2008

Last Updated

September 2, 2020

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00740142

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Encephalopathy

Keywords

L ornithine L aspartate, Lactulose, Hepatic encephalopathy, LOLA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

Oral lactulose

Intervention Type

Drug

Intervention Name(s)

L-ornithine-L-aspartate and lactulose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo and lactulose

Intervention Description

placebo 3 times a day for 7 days

Primary Outcome Measure Information:

Title

To assess improvement of mental status of the patients

Time Frame

7 days

Secondary Outcome Measure Information:

Title

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

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Siwaporn Chainuvati, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital, Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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