Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: N/A: N/A
Control Intervention1: L ORNITHINE L ASPARTATE: DOSE- 20-30 g over 2-3 hrs
ROUTE- INTRAVENOUS
DURATION- 3-7 DAYS
Control Intervention2: Tab Rifaximin
Syrup Lactulose: Rifaximi
Sponsors
Dr Saheli Das
Eligibility
Inclusion criteria
Inclusion criteria: 1)In-Patients diagnosed of Overt Hepatic Encephalopathy (Grade 2 or more) according to West Haven’s criteria who are on lactulose and rifaximin 2)Subjects/ LARs willing to comply with the study procedures and willing to give written informed consent 3) Patients should be capable to comprehend letters and numbers
Exclusion criteria
Exclusion criteria: 1)Pregnant and lactating women 2) History of hypersensitivity to any drug or the study drug 3) History of intake of any drugs that may interfere with CNS activity 4) Subjects with pre existing medical conditions like cardiac , pulmonary or neurological disease/psychiatric disorder which in the judgement of the clinician would interfere with the study 5) Serum creatinine > 3 mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the change in neurological status by West Haven scoring at the end of 1 week from the baselineTimepoint: 1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine change in fasting serum ammonia at the end of 1 week from the baseline visit 2. To compare the psychometric test parameters (NCT A ,NCT B, DLST) between both the groups at the end of 1 week of treatment. 3.To compare the QoL between both the groups using SF-36 Questionnaire at the end of 1 week of treatment. 4.To compare the occurrence of adverse effectsTimepoint: 1 week | — |
Countries
India
Contacts
Public ContactDr Saheli Das
NIZAMS INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed