Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 30 to 60 years with a confirmed diagnosis of NAFLD either by history or NAFLD Score between -1.455 and 0.675.
Exclusion criteria
Exclusion criteria: History of significant alcohol consumption, presence of other chronic liver diseases (e.g., viral hepatitis, autoimmune hepatitis), or ongoing use of hepatoprotective agents or lipid-lowering medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Non alcoholic fatty liver fibrosis score at Week 4 and week 8.Timepoint: 2nd,4th 6th,and 8th wk | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Chronic Liver Disease Questionnaire for NAFLD/NASH at baseline and week 8.Timepoint: Baseline and 8th week;Safety assessment through LFT, RFT and CBC, adverse events categorised according to CTCAE version 4.03 where study specific AE is defined with a severity of grade 3 or more and(or) that leads to discontinuation of the study drugTimepoint: 2nd,4th 6th,and 8th wk | — |
Countries
India
Contacts
The Arya Vaidya Pharmacy (Coimbatore) Limited