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Clinical Trials/CTRI/2023/12/060736
CTRI/2023/12/060736
Not yet recruiting
Phase 4

Prospective randomised study of therapeutic effects of Saroglitazar and Dapagliflozin in patients with type 2 diabetes mellitus and Non Alcoholic Fatty liver disease - NI

Deepthi v0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Deepthi v
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Deepthi v

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with NAFLD diagnosed on ultrasonography
  • •2\.HbA1C \>6\.5%
  • •3\.BMI \>25
  • •4\.Willingness to comply with all protocol required evaluations

Exclusion Criteria

  • •1\.Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).
  • •2\. Average alcohol consumption greater than equal to 21 drinks per week formen, greater than
  • •equal to 14 drinks per week for women in the 6 months before enrollment.
  • •3\.The patients who already used medications known to cause hepatic steatosis for more than two weeks in the past year such as mipomersen, lomitapide, amiodarone, methotrexate, tamoxifen, corticosteroid, valproate,
  • •antiretroviral medicines.
  • •4\.Presence of alternative cause of fatty liver, including Total Parenteral Nutrition,
  • •Starvation, Lipodystrophy, \-Abetalipoproteinemia, Acute fatty liver of pregnancy, HELLP syndrome, Reye’s syndrome. Clinical, imaging, or histological evidence of cirrhosis.
  • •5\.Use of drugs with a potential effect on NASH such as ursodeoxycholic acid, vitamin E, pioglitazone.
  • •6\.Pregnant or lactating female.

Outcomes

Primary Outcomes

Not specified

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