Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
BVG life Sciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of hepatic disorder with abnormal LFT with or without signs and symptoms such as dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, and right upper abdominal discomfort, pain or feeling of pressure 2.Definitive diagnosis of NAFLD (by USG) or NASH by imaging evidence (USG or liver elastography, Metavir scoring F2 and F3 and liver stiffness more than 8kPa) 3.Subjects willing to sign inform consent form
Exclusion criteria
Exclusion criteria: 1.Other causes of liver disease including evidence of chronic viral hepatitis (Hepatitis B or C) and Biliary obstruction 2.AST more than 500 U/L or ALT more than 300 U/L 3. ( Metavir scoring F4 or liver stiffeness more than 17kPa ) 4.Suspected hypersensitivity to contents of study drug 5.Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy, hepatic cancer) 6.Subjects with serious illness, e.g., uncontrolled diabetes, multisystem failure, HIV, cancer, severe renal insufficiency, serious cardiovascular disease and patients with history of gastritis, peptic ulcer, bleeding ulcer 7.Patients with a renal failure 8.Pregnant or lactating women 9.Subjects with Moderate to high Physical activity having energy expenditure of 3.5 to 7 kcal/min 10.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is to evaluate the changes in Ultrasound guided Liver elastography at screening and end of the treatment (Metavir scoring F3 to lower and changes in liver stiffeness in pascal) at 12 week from baseline.Timepoint: baseline to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| evaluate the changes in serum total bilirubin, AST, ALT, serum BilirubinTimepoint: baseline to 12 weeks;Assessment of change in symptoms of liver disease like anorexia, fatigue, abdominal pain, nauseaTimepoint: baseline to 12 weeks;Adverse events profileTimepoint: baseline to 12 weeks;Compliance and tolerability of the investigational product throughout the studyTimepoint: baseline to 12 weeks | — |
Countries
India
Contacts
Public ContactDr Kshipra Rajoria
National institute of Ayurveda Jaipur
Outcome results
None listed