NCT01887275

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 439 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DEVICE	medical ozone therapy with humares	Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment. 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.
DRUG	conventional interferon-α	Patients in the conventional interferon-α treatment group received subcutaneouslly injection of 5 million units of conventional interferon-α in three times per week for at least 24 weeks.

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-06-26
• Last updated: 2013-06-26

Locations

1 site across 1 country: China