Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Drug Interventiom: 2 drugs will be used. One of the drug will be used alone. And second drug will be used in combination with the 1st drug. And the effect of monotherapy will be compare
Sponsors
MGM Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients having Fatty Liver Grade 1 to 3 on USG Ultrasound Attenuation Parameter more than 244 db./m. Patients with F0 to F3 fibrosis on TE. Individuals with BMI more than 23 kg per m2 Patient willing to participate in the study and give written informed consent
Exclusion criteria
Exclusion criteria: Patients with significant alcohol consumption per day. Patients with BMI less than 23 kg/m2. Pre-diabetic patients and patients with known history of lean NASH. Patients having F4 fibrosis on TE. Patients having chronic viral hepatitis B and C. Patients having other chronic liver diseases. Patients having thyroid dysfunction or any metabolic disorder, except diabetes. Patients taking any concurrent medications known to affect liver enzymes or CBC. Patients showing intolerance to Saroglitazar and Vitamin E. Pregnant and Lactating women. Patients not willing to participate in the study and give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat content and fibrosis will be assessed at the end of the study i.e. at 12 monthsTimepoint: Visit 0 Baseline Visit 1 at 3 months Visit 2 at 6 months Visit 3 at 9 months End of therapy visit at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the occurrence of adverse drug reactions to Vit E & SaroglitazarTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactAnuj Satarkar
MGM Medical College and Hospital
Outcome results
None listed