Health Condition 1: K768- Other specified diseases of liver
Conditions
Interventions
Intervention1: Alpha Keto Analogues Tablet with standard of care: Alpha Keto Analogues of essential amino acids tablet will be given as add on to standard of care for 90 days
Control Intervention1: St
Sponsors
Dr Vinay Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 to 65 years male and female both. 2. Cirrhosis diagnosed on the basis of clinical features, biochemical, radiological and or liver histology data. 3. Diagnosed with hepatic encephalopathy having Grade 2 and 3 4. Diagnosed with hepatic encephalopathy at least 7 days prior to screening. 5. Ammonia level more than 170.
Exclusion criteria
Exclusion criteria: 1. Current or recent (less than 6 weeks) use of alcohol 2. Use of antibiotics within last 6 weeks 3. Use of lactulose, lactitol, L-ornithine L-aspartate and zinc within the last 6 weeks 4. Use of interferon or psychoactive drugs like benzodiazepines, psychotropic drugs, anti-epileptics within the last 6 weeks 5. Infection or gastrointestinal hemorrhage within the last 6 weeks 6. Advanced medical problems like congestive cardiac failure, advanced pulmonary disease or renal insufficiency or electrolyte imbalance 7. Hepatocellular carcinoma 8. History of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt 9. Pregnancy and breastfeeding 10. Neurological or psychiatric problems which may influence quality of life measurement. 11. Poor vision or motor defects which interfere with the performance of psychometric tests. 12. Any condition which may not appropriate for study result as per PI discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in arterial ammonia concentration from baselineTimepoint: Screening, day 30, day 60, day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in grades of hepatic encephalopathyTimepoint: Screening, Day 90;Reduction of ammonia level to at least 50% from the baseline at the end of treatment.Timepoint: Baseline, Day 90;Improvement in quality of life using EQ-5DTimepoint: Baseline, Day 90;Mental State Examination using MMSETimepoint: Baseline, Day 90;Adverse EventsTimepoint: Screening, Day 0, day 30, day 60, day 90 | — |
Countries
India
Contacts
Public ContactRakesh S Ray
GSVM Medical Collage
Outcome results
None listed