CTRI/2024/03/063735尚未招募3 期
Effect of Saroglitazar on hepatic steatosis in non-alcoholic fatty liver disease patients: a randomised double blind placebo controlled trial - NAFLD
o sponsor0 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
- 3 期
- 状态
- 尚未招募
- 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
- •i) Age -18-60 years
- •ii) Either of the gender (Male and female)
- •iii)Evidence of fatty liver on USG
- •iv) Patient’s willingness to comply with the study protocol and prior written informed consent
排除标准
- •1)Alcoholics for past 6 months
- •2)Patients with type i or type 2 diabetes mellitus
- •3) Patients with alternate causes of fatty liver including:
- •-Patients on TPN and those who underwent surgical procedures within 90 days
- •from randomization
- •-presence of other chronic liver disease such as hepatitis B or C, liver
- •cirrhosis, Wilson’s disease or any other autoimmune condition leading to fatty liver
- •4) Use of drugs with potential effect on NASH such as: Ursodeoxycholic acid, SAdenosyl Methionine(SAM-e), Betaine, Pentoxyfylline, Obeticholic acid, milk thistle, Vitamin E, statins, CYP3C8 inhibitors or substrate -within 3 months before visit 1
- •5) Presence of bleeding disorders, myopathy, malignancy, hypothyroidism
- •6) Presence of anaemia, acute or chronic kidney disease, acute or chronic liver disease
- •7) Participation in other NAFLD/NASH related study within last 3 months
- •8) Pregnant or lactating females or couples planning pregnancy within 3 months
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