CTRI/2023/03/050213
Not Yet Recruiting
Phase 3
A prospective single centre observational study to evaluate effectiveness and safety of Saroglitazar 4mg Vs Obeticholic acid 10 mg in pateints with non alcoholic fatty liver disease ( NAFLD)/ Non alcoholic Steatohepatitis (NASH). - OCASAR in NAFLD/ NASH
Department of Medical gastroenterology0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Sponsor
- Department of Medical gastroenterology
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (age 18 to 60\) being managed or treated for NAFLD.
- •The patient must qualify for NAFLD, according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasani et al.2017\).
- •(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.
- •Patientâ??s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol\-required evaluations.
- •The subjects underwent Fibroscan per the protocol described prior to enrolment and subsequently, they were contacted to participate in the follow\-up study at 24 .
- •The lipid profile range in the inclusion criteria. TG \>\= 150mg/dl and LDL \>\= 100mg /dL and HDL \<\= 40 mg /dL.
Exclusion Criteria
- •Presence of regular or excessive use of alcohol within 2 years prior to initial screening.
- •Presence of alternative causes of fatty liver, including:
- •History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small\-bowel resection, or orthotopic liver transplants (OLT)
- •History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis
Outcomes
Primary Outcomes
Not specified
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