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临床试验/ITMCTR1900002617
ITMCTR1900002617招募中1 期

Study for Optimized protocol of Traditional Chinese Medicine in the Treatment of Chronic Hepatitis B Virus Carriers

Shenzhen Traditional Chinese Medicine Hospital0 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
30 至 65(—)
性别
All

入选标准

  • 1. Patients meet the diagnostic criteria for chronic HBV carriers
  • (1) serum HBsAg, HBeAg and HBV-DNA are positive;
  • (2) patients are fluped 3 times in one year, whose serum ALT, AST are within the normal range;
  • (3) Fibroscan<7.0 kPa or liver histological examination shows no obvious abnormalities.);
  • 2. The differentiation of traditional Chinese medicine meets spleen-kidney deficiency syndrome;
  • 3. Aged between 30-65 years, patients have been infected HBV for more than 20 years;
  • 4. Serum ALT <=40 U/L;
  • 5. Serum HBV-DNA: >10^5 IU/ml, <10^9 IU/ml;
  • 6. Histological Knodell HAI<4 score, Ishak<=3 score, or Fibroscan<7.0 kPa;
  • 7. Patient sign the informed consents and volunteer to participate in this clinical trial.

排除标准

  • 1. Patients infect HIV, HCV and HDV;
  • 2. Patients with metabolic or autoimmune liver disease;
  • 3. Patients have a history of alcohol abuse or illicit drugs or participate in other clinical trials of hepatitis drugs within 30 days;
  • 4. Serum ALT and AST levels show abnormality with one years;
  • 5. Patients are treated with nucleoside or interferon for 24 weeks prior to enrollment;
  • 6. Inactive HBsAg carriers;
  • 7. Patients with cirrhosis or patients' AFP are increased;
  • 8. Pregnant or lactating women;
  • 9. Patients with mental disease and other serious organ diseases.

研究者

发起方
Shenzhen Traditional Chinese Medicine Hospital

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