L-ornithine L-aspartate (6 ampules, each ampule containing 5 grams of the drug in 10 ml solution) to be diluted in 440 ml of Dextrose 5% (to make a total of 500 ml of solution), as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo (sterile water, 6 ampuoles of 10 ml each) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Cirrhosis of Liver

Hepatic Encephalopathy

L-ornithine L-aspartate

Placebo (sterile water, 60 ml) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days

Placebo

Department of Gastroenterology, D.M.C. and Hospital

G.B. Pant Hospital

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

Efficacy of Intravenous 'L-ornithine L-aspartate' in Reversal of Overt Acute Hepatic Encephalopathy in Patients With Liver Cirrhosis: a Prospective, Randomized, Double-blind, Placebo Controlled Trial

Mental state grade according to West Haven criteria for Hepatic encephalopathy

Change in blood ammonia levels will be measured at baseline and after 5 days of treatment

Mortality rate in the two groups at 4 weeks will be compared

The total length of hospital stay (number of days) in each group will be compared.

Change in serum cytokine levels (Interleukin-1, Interleukin-6, Interleukin-10 and TNF-alpha will be measured at baseline and after 5 days of treatment.

Prof. Sandeep S Sidhu

Professor

Dayanand Medical College and Hospital

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

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

ornithine/nausea

L-ornithine L-aspartate in Overt Hepatic Encephalopathy

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

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