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临床试验/CTRI/2023/07/055756
CTRI/2023/07/055756招募中2 期

Comparative study of efficacy and safety of Empagliflozin and Pioglitazone in Non-alcoholic fatty liver disease with Diabetes Mellitus. - NI

Delhi Pharmaceutical Sciences and Research University0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Patient having age group 25 to 75 years with documented diagnosis of Diabetes (HbA1C > 6.5%) with NAFLD (findings suggested hepatic steatosis & hepatic dysfunction on clinical laboratory tests or on imaging studies (e.g., Computed Tomography (CT) or ultrasound) or Calculated fibrosis score by Fib-4 Score > 1.3, NAFLD-LFS score > 0.064 & APRI Score range 0.4 - 1.5).

排除标准

  • 1.Patient not willing to give consent form.
  • 2.Patient with alcohol consumption.
  • 3.Lactating & pregnant women.
  • 4.Patient who already using drug such as SGLT-2 inhibitors, Pioglitazone, Insulin, GLP1Ra or drugs related with NAFLD for more than 12 sequential weeks before first visit in OPD.
  • 5.Use of other drugs such as tamoxifen, methotrexate, amiodarone, systemic gluco-corticoids, tetracyclines, anabolic steroids, high doses of estrogens, oral contraceptives, L-asparaginase, sodium valproate, chloroquine & HIV-drugs.
  • 6.Patient with serum positive Hepatitis-B surface antigen or anti-HCV & those who are contraindicated for SGLT-2 Inhibitors & Pioglitazone were excluded.

研究者

发起方
Delhi Pharmaceutical Sciences and Research University

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