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临床试验/NCT01342185
NCT01342185Unknown3 期

A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY-CZ-9999 Ozone Therapy System

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
189
试验地点
1
主要终点
HBV DNA

研究概览

简要总结

The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.

详细描述

Total of 189 patients with compensated chronic hepatitis B will be divided equally and randomly into three arms. Patients in arm I and II treated with medical ozone therapy with different medical ozone generators, one was made in Tianyi medical instruments limited company and the other in Germany. Sixty-three patients of arm III treated with Diammonium glycyrrhizinate Capsules, common used liver protective herb drug. The term of therapy is 12 weeks. Virology response, biochemistry response and hepatitis B viral serological response will be studied at the end of 12 weeks treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, not less than 16 years old;
  • HBsAg positive for over 6 months;
  • ALT over 2×ULN, TBIL less than 80µmol/L and serum HBV DNA over 10000copies/ml。

排除标准

  • Patient has a history of hemorrhagic or hemolysis disease;
  • Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
  • Patient is co-infected with HIV or HCV;
  • Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
  • Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
  • Current alcohol or drug abuse;
  • Difficulty to draw blood through veins;
  • Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
  • Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
  • Patient is enrolled in any other clinical trials.

研究组 & 干预措施

Medical ozone therapy with tianyi

Experimental

干预措施: medical ozone therapy with tianyi (Device)

medical ozone therapy with humares

Active Comparator

干预措施: medical ozone therapy with humares (Device)

Diammonium glycyrrhizinate Capsules

Placebo Comparator

干预措施: Diammonium glycyrrhizinate Capsules (Drug)

结局指标

主要结局

HBV DNA

时间窗: week 12

To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL or decreased 100 times at week 12.

次要结局

  • HBeAg(week12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

guoyabing

professor

Nanfang Hospital, Southern Medical University

研究点 (1)

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