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临床试验/ITMCTR2100004809
ITMCTR2100004809招募中1 期

Clinical Efficacy Evaluation of Jianpi Huoxue Decoction in the Treatment of Non-alcoholic Fatty Liver Disease

Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine0 个研究点开始时间: 待定最近更新:

试验速览

阶段
1 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 study

入排标准

年龄范围
18 至 65(—)
性别
All

入选标准

  • 1.Patient who meet the diagnostic spleen deficiency and blood stasis syndrome of non-alcoholic fatty liver;
  • 2.Aged 18 to 65 years;
  • 3.MRI-pdff liver fat content > 5%, BMI < 35 kg/m2;
  • 4.Voluntarily follow scheduled medical visits, dietary and exercise instructions, laboratory tests, and other study procedures;
  • 5.ALT less than or equal to 5 times upper than normal limit;
  • 6.Sign patient informed consent.

排除标准

  • 1.Someone who have used liver protection drugs and enzyme lowering drugs which can impact on efficacy evaluation in the past 1 month;
  • 2.Someone who have used Tamoxifen, Amiodarone, sodium valproate, methotrexate, glucocorticoids or other drugs which can affects lipid metabolism in the past 3 month;
  • 3.Someone who has comorbidity just like total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, ß-lipoprotein deficiency, lipid atrophic diabetes, Mauriac syndrome and other disease can lead to fatty liver disease;
  • 4.Someone who has alcoholic fatty liver disease (male alcohol intake>30g/d, female alcohol intake>20g/d), cirrhosis, Hepatitis B, Hepatitis C and other liver diseases, autoimmune liver disease or liver decompensating;
  • 5.T2DM patients whose disease without well control (HbA1c >= 9.5% in the past month);
  • 6.ASCVD in high and very high-risk patients;
  • 7.Someone whose weight lose 10% in the past 3 months because of bariatric surgery or diet pills;
  • 8.Someone who with history of substance abuse or drug addiction;
  • 9.Pregnant and lactating women, patients with cardiovascular, lung, kidney, hematopoietic system and other major primary diseases as well as malignant tumor.

研究者

发起方
Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine

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