CTRI/2019/06/019592已完成4 期
Comparative Effectiveness of Ranolazine and Saroglitazar on Non-Alcoholic Fatty Liver Disease in Patients with Diabetic Dyslipidemia: A Randomized controlled open label trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Self
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
- •Had ALT above upper limits of normal (19 U per
- •L for women, 30 U per L for men).
- •-Had ALD or NAFLD Index less than 0.
- •-Had documented hepatic steatosis (Fatty Liver
- •Index greater than equal to 60, NAFLD-FAT
- •SCORE greater than minus 0.640, Hepatic
- •steatosis index greater than equal to 36,
- •NAFLD fibrosis score less than minus
- •1.455,Liver Accumulation Product greater than
- •equal to 80).
- •-HbA1C greater than equal to 7%
- •-Willingness to comply with all protocol
- •required evaluations; provision of written
- •informed consent before any study specific
- •tests or procedures are performed.
排除标准
- •-Presence of other chronic liver diseases
- •(hepatitis B or C, autoimmune hepatitis,
- •cholestatic liver disease, Wilsons disease,
- •hemochromatosis, etc.).
- •-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.
- •-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.
- •-Presence of alternative cause of fatty liver,
- •including Total Parenteral Nutrition,
- •Starvation, Lipodystrophy,
- •-Abetalipoproteinemia, Acute fatty liver of
- •pregnancy, HELLP syndrome, Reyeââ?¬•s syndrome.
- •Clinical, imaging, or histological evidence of
- •-Use of drugs with a potential effect on NASH
- •such as ursodeoxycholic acid, vitamin E,
- •pioglitazone.
- •-Pregnant or lactating female.
研究者
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