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A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:
Medical Ozone Versus Conventional Interferon-α Treatment of Patients With Chronic Hepatitis B —A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.

Clinical Trial Description

Total of 439 patients with chronic hepatitis B were divided according to patients' intention into two arms. 173 patients in arm I were treated with medical ozone therapy with humares which was made in Germany for at least 12 weeks.266 patients in arm II were treated with conventional interferon-α for at least 24 weeks.Patients in both groups were followed-up for 24 weeks.Virology response, biochemistry response and hepatitis B viral serological response will be studied at 12 weeks after the treatment, at the end of treatment and after 24 weeks of follow-up. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01887275
Study type Interventional
Source Nanfang Hospital of Southern Medical University
Contact
Status Completed
Phase Phase 4
Start date March 2010
Completion date February 2013
View Details
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