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Comparative Study Of Saroglitazar In Patients Of Non Alcoholic Fatty Liver Disease With Type 2 Diabetes Mellitus And Non Diabetic Population

Randomised Open Label Comparative Study Of Saroglitazar In Patients Of Non Alcoholic Fatty Liver Disease With Type 2 Diabetes Mellitus And Non Diabetic Population - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059677
Enrollment
120
Registered
2023-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: K758- Other specified inflammatory liverdiseases

Interventions

Intervention1: SAROGLITAZAR: Dose- 4mg Frequency- once daily Route of administration- oral Duration - 6 months Patients with and without diabetes will be receiving saroglitazar. Effect of drug throug

Sponsors

Arsh gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Presence of fatty liver on ultrasound Patients with Type2DM Patients without diabetes

Exclusion criteria

Exclusion criteria: presence of chronic hepatitis B or C infection (positive Hbs Ag or anti HCV Ab) , significant alcohol intake ( >20 gm/ day for males and >10 gm/day for females). Cases with a history of intake of hepatotoxic drugs, drugs leading to hepatic fibrosis or drugs supposed to decrease hepatic fibrosis ( obeticholic acid, vitamin E , pioglitazone, UDCA, omega fatty acid ) , documented cases of autoimmune hepatitis, hepatic storage disorders such as hemochromatosis and Wilson’s disease will be excluded. Patients having others co-morbidities like hypothyroidism, ischemic heart disease or chronic kidney disease will not be included. Pregnant patient will not be included.

Design outcomes

Primary

MeasureTime frame
Liver Stiffness measurement score by FibroscanTimepoint: once before initition of drug and once after completion of 6 months course of drug

Secondary

MeasureTime frame
SGOT SGPT TPC APRI FIB 4 NAFLD FIBROSIS SCORETimepoint: 6 MONTHS

Countries

India

Contacts

Public ContactDr ARSH GUPTA

IMS and SUM hospital

drchandan1204@gmail.com9937063390

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026