Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: KaraLiv: Eligible subjects will be administered with KaraLiv 500 mg capsule twice daily for 56 days
Control Intervention1: Placebo: Eligible subjects will be administered with Placebo 5
Sponsors
Green Chem
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged between 18 to 60 years with the evidence of elevated liver function tests, based on thorough medical history, physical examination, and other laboratory tests. 2.Subjects able to provide written informed consent and able to understand and willing to comply with the requirements of the study. 3.Subjects with ALT and AST elevated �1.5 times the upper limit of normal 4.Subjects with the Ratio of AST to ALT should be greater than 1.5
Exclusion criteria
Exclusion criteria: 1. Pregnancy or child bearing potential who are at risk of pregnancy 2.Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months 3.Severe renal impairment (Glomerular filtration rate below 60 ml/min per 1.73m2) 4.Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilsons disease 5.Severe alcoholic hepatitis with cirrhosis 6.Participants with active viral hepatitis 7.Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry 8.Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc. 9.Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days. 10.Any other condition that, in the opinion of the investigator, would adversely affect the subjectââ?¬•s ability to complete the study or its measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study in AST (Aspartate Aminotransferase)Timepoint: Baseline to End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study in ALP (Alkaline Phosphatase)Timepoint: Baseline to End of the study;Change from baseline to end of the study in ALT (Alanine Aminotransferase)Timepoint: Baseline to End of the study;Change from baseline to end of the study in serum total bilirubinTimepoint: Baseline to End of the study;Change in QOL- Psychosocial HealthTimepoint: Baseline to End of the study;Change in Quality of Life (QOL) Scores- Physical HealthTimepoint: Baseline to End of the study;Changes from Baseline to the end of the study in GGT (Gamma-glutamyl transferase)Timepoint: Baseline and End of the study;Changes from Baseline to the end of the study in Malondialdehyde (MDA)Timepoint: Baseline and End of the study;Changes from Baseline to the end of the study in Superoxide Dismutase (SOD)Timepoint: Baseline and End of the study;Changes from Baseline to the end of the study SHBG (Sex hormone binding globulin)Timepoint: Baseline and End of the study;To assess the Safety and Tolerability of KARALIVTimepoint: Baseline to End of the study | — |
Countries
India
Contacts
Public ContactR Rajendran
Green Chem
Outcome results
None listed