Trial | NCT01342185  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    glycyrrhizin ozone ...

  • Study Participants

    189
The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.
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.
Study Started
Mar 31
2010
Primary Completion
Jul 31
2013
Anticipated
Study Completion
Jul 31
2013
Anticipated
Last Update
Oct 18
2012
Estimate

Device medical ozone therapy with tianyi

Medical ozone therapy with instrument made in China Patients in this arm will receive autohemotherapy. First month: ozone concentration: 20µg ~40µg /ml;The second month: 30µg/ml × 100ml oxygen- ozone gas × 100 ml blood;The third month: 20µg/ml × 100ml oxygen- ozone gas× 100 ml blood.

  • Other names: ozone instrument made in China: TianYi

Device medical ozone therapy with humares

Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.

  • Other names: ozone instrument made in Germany: Humares

Drug Diammonium glycyrrhizinate Capsules

Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.

  • Other names: ganlixin capsules

Medical ozone therapy with tianyi Experimental

medical ozone therapy with humares Active Comparator

Diammonium glycyrrhizinate Capsules Placebo Comparator

Criteria 

Inclusion Criteria:

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。

Exclusion Criteria:

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;
Pregnancy;
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.
No Results Posted