NCT01677325已完成1 期
The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- The CT ratio of liver/spleen
研究概览
简要总结
To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.
详细描述
- Liver fat (measured by CT scan) and liver function assessed by liver enzymes levels; 2) Insulin sensitivity measured by HOMA index, oral glucose tolerance test (OGTT) and a euglycaemic hyperinsulinaemic clamp (with stable isotopes) in a subset of the subjects; 3) Plasma lipid profile and non esterified fatty acids (NEFA) concentration; 4) Circulating levels of adipokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •subjects with NAFLD(nonalcoholic fatty liver disease) (criteria of Society of Hepatology, Chinese Medical Association, 2002.10),
- •aged 18-65
- •alcohol consumption less than 40g/week;
- •liver/spleen (L/S) ratio no more than 1 by CT scan.
排除标准
- •ALT more than twice the upper end of the normal range
- •viral hepatitis
- •total parenteral alimentation or secondary liver disease such as hepatocirrhosis, autoimmune hepatitis, metabolic liver disease or drug induced liver disease
- •severe cardiovascular or renal dysfunction
- •Subjects with diabetes (fasting glucose more than or equal to 7.0mmol/L or postprandial glucose more than or equal to 11.1mmol/L)
- •Subjects treated with statins
研究组 & 干预措施
Chinese herb
Experimental
Chinese herb
干预措施: Chinese herb (YiQiSanJu) (Drug)
结局指标
主要结局
The CT ratio of liver/spleen
时间窗: 12 weeks
CT imaging has been used to assess hepatic steatosis and has been validated in relation to liver biopsy .The ratio of liver to spleen (L/S ratio) for CT attenuation values is an index, with a L/S ratio\<1 considered to represent fatty liver .
次要结局
- BMI(Body Mass Index )(12 weeks)
- liver function(12 weeks)
- lipid profile(12 weeks)
- NEFA(nonesterified fatty acid)(12 weeks)
- HOMA index(12 weeks)
- adiponectin(12 weeks)
- IL-6(interleukin 6)(12 weeks)
- hs-CRP (C-reactive protein)(12 weeks)
- TNFα( tumor necrosis factor-α)(12 weeks)
- leptin(12 weeks)
研究者
相似试验
已完成
不适用
Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic FactorsNon-alcoholic Fatty Liver DiseaseLiver FibrosisLiver InjuryNCT06244550Taipei City Hospital60
尚未招募
不适用
Research of Non-alcoholic fatty liver disease(NAFLD) and Non-alcoholic steatohepatitis(NASH) using the measuring instrument of ethanol metabolismJPRN-UMIN000024594Department of hepatology and pancreatology, Aichi Medical University90
招募中
2 期
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)Non-Alcoholic Fatty Liver DiseaseNon-Alcoholic SteatohepatitisNCT03884075National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)104
已完成
2 期
Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin EFatty LiverNCT01792115National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)22
Unknown
不适用
Treatment of Non Alcoholic Fatty Liver Disease With Lifestyle Modification and AcupunctureNAFLDAccupunctureNCT02006329Ziv Hospital60