Comparative evaluation of Ursodeoxycholic Acid versus Vitamin E in Metabolic Dysfunction Associated Steatotic liver disease with Type 2 Diabetes Mellitus

Effect of ursodeoxycholic acid versus vitamin E in Metabolic Dysfunction associated steatotic liver disease with type 2 diabetes mellitus, a randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113762

Enrollment

120

Registered

2026-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

Intervention1: Ursodeoxycholic acid: Tab Ursodeoxycholic acid 300mg twice a day will be administered orally to 60 individuals of one group and the effect will be assessed after 3 months Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: 1.diagnosed cases of type 2 diabetes mellitus 2.ast and alt elevation of less than 2 times 3.evidence of hepatic steatosis 4.BMI more than 25

Exclusion criteria

Exclusion criteria: 1.alcohol intake more than 20g per day in women and more than 30 g in men 2.chronic liver disease 3. history of hepatotoxic drug use 4. pregnancy or lactation 5.uncontolled diabetes 6.patients with obstuctive cholestasis severe cirrhosis hepatic encephalopathy

Design outcomes

Primary

Measure	Time frame
changes in liver enzymes AST and ALT changes in hepatic steatosis via Fib 4 score and usgTimepoint: 3 months	—

Secondary

Measure	Time frame
change in glycemic control change in lipid profile weight and BMI fibrosis assessmentTimepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Shilpa Bawankule

Datta Meghe Institute of Higher Education and Research

drshilpagaidhane@gmail.com9673288822

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026