Effect of the drug L Ornithine L Aspartate (LOLA) in liver disease
Not Applicable
Not yet recruiting
- Conditions
- Health Condition 1: K769- Liver disease, unspecified
- Registration Number
- CTRI/2023/09/057449
- Lead Sponsor
- Dr Saheli Das
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To determine the change in neurological status by West Haven scoring at the end of 1 <br/ ><br>week from the baselineTimepoint: 1 week
- Secondary Outcome Measures
Name Time Method 1. To determine change in fasting serum ammonia at the end of 1 week from the baseline <br/ ><br>visit <br/ ><br>2. To compare the psychometric test parameters (NCT A ,NCT B, DLST) between both the <br/ ><br>groups at the end of 1 week of treatment. <br/ ><br>3.To compare the QoL between both the groups using SF-36 Questionnaire at the end of 1 <br/ ><br>week of treatment. <br/ ><br>4.To compare the occurrence of adverse effectsTimepoint: 1 week