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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Drug: L-ornithine-L-aspartate and lactulose
* Drug: placebo and lactulose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess improvement of mental status of the patients |  | 7 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L ornithine L aspartate, Lactulose, Hepatic encephalopathy, LOLA