JPRN-UMIN000004034已完成未知
A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia - A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia
Division of Gastroenterology, Saiseikai Suita Hospital0 个研究点目标入组 60 人开始时间: 2010年8月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)During the pretreatment period, the patient treated with a choleretic drug, a glycyrrhizin-combination drug, an immunotherapeutic drug, an adrenal corticoid, a liver hydrolysate, an enhancement drug of liver function, a Saiko-prescription, a bile-acid sequestrant, a phlebotomy or a folk medicine which may affect the target disorder. 2)During the pretreatment period, the patient with a discontinuation, an alternation of dose or dosage regimen, or a new additional dosage of the following drug: a) Antidiabetic drugs: an insulin preparation, a SU drug, a biguanide, an alpha-gluosidase inhibitor, a drug for postprandial hyperglycemia of the early phase, a DPP4 inhibitor, b) Anti-oxidants: a vitamin E preparation, a N-Accetyl-Cysteine preparation, c) Hypolipidemic drugs: a fibrate, a HMG-CoA reductase inhibitor, a probucol, an EPA capsule, an intestinal cholesterol-transporter inhibitor, d) Anti-hypertensive drugs: an angiotensin II receptor type-1 antagonist (ARB). 3)The patient with type1 or 2 of the Matteoni classification from biopsy examination. 4)The patient with cirrhosis diagnosed from biopsy examination (diagnosis as F4 from liver biopsy). 5)The patient in cancer therapy. 6)The patient with complete biliary atresia. 7)The patient in therapy of fulminant hepatitis. 8)The patient during pregnancy, feeding, intimation of pregnancy or intended pregnancy. 9)The patient with history of hypersensitivity to test drug 10)The patient who was diagnosed as an inappropriate one by the researcher.
研究者
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