Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adults (age 18 to 60) of either sex with BMI greater than 25.00 and less than, equal to 32.00 kgerm2. 2) Confirmed Diagnosis of NAFLD established by imaging (ultrasound/Fibroscan, CT scan or MRI), within 3 months of the screening phase. The diagnosis of NAFLD is made according to the American Association for the Study of Liver Diseases (AASLD) criteria defined as complying following- a) There is hepatic steatosis by imaging or histology, b) There is no significant alcohol consumption, c) There are no competing aetiologies for hepatic steatosis, d) There are no co-existing causes for chronic liver disease. 3) Liver Steatosis Grade I, II, and III along with hepatomegaly by USG abdomen pelvis/Fibroscan at screening,
Exclusion criteria
Exclusion criteria: 1) Regular or excessive use of alcohol within 2 years prior to initial screening. 2) Subjects with uncontrolled diabetes and changed medication in the past 3 months. 3. Presence of alternative causes of fatty liver 4) Weight loss morethan10% in the 6 months before the Screening Visit. 5) History of myopathies or evidence of active muscle disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in:1) NAFLD fibrosis score (NFS) 2) Liver Steatosis Grade I, II, and III along with hepatomegaly 3) Parameters of liver function test (LFT) 4) Severity grading of symptoms such as abdominal pain, abdominal tenderness, nausea, loss of appetite, fatigue, itchy skin, and jaundice on 4 points Linkert scale (None, mild, moderate and severe)Timepoint: visit 1, 2, 3 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in: 1. Size of spleen and gallbladder by USG. 2. AST to Platelet Ratio Index (APRI) 3. Glycaemic profile assessed by serum levels of insulin, fasting plasma blood sugar and HbA1c 4. Insulin Resistance assessed by HOMA-IR score 5. Anthropometric parameters like body weight, BMI, waist circumference at screening and end of the study. 6. Parameters in lipid profile like total cholesterol, HDL, LDL, triglyceride etc. at screening and end of the study. Timepoint: visit 1, 2, 3 and 4 | — |
Countries
India
Contacts
Public ContactDr Baidyanath Mishra
Dabur Research and Development Centre Dabur India limited
Outcome results
None listed