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

This study has been completed.
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University Identifier:
First received: June 23, 2013
Last updated: June 25, 2013
Last verified: October 2012
The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.

Condition Intervention Phase
Chronic Hepatitis B
Device: medical ozone therapy with humares
Drug: conventional interferon-α
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • HBV DNA [ Time Frame: up to 77 weeks ]
    To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL

Secondary Outcome Measures:
  • HBeAg [ Time Frame: up to 77 weeks ]
    Percentage of patients with HBeAg loss and HBeAg seroconversion in patients with HBeAg positive at baseline.

Enrollment: 439
Study Start Date: March 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: medical ozone therapy with humares 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.
Other Name: ozone instrument made in Germany: Humares
Active Comparator: conventional interferon-α 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.

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.

Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female;
  • HBsAg positive for over 6 months;
  • ALT over 2×ULN, TBIL less than 80 µmol/L.

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.
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Please refer to this study by its identifier: NCT01887275

China, Guangdong
Nanfang Hospital
GuangZhou, Guangdong, China, 510000
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Principal Investigator: yabing guo, professor Nanfang Hospital of Southern Medical University
  More Information

Responsible Party: Nanfang Hospital of Southern Medical University Identifier: NCT01887275     History of Changes
Other Study ID Numbers: gyb61641947
Study First Received: June 23, 2013
Last Updated: June 25, 2013

Keywords provided by Nanfang Hospital of Southern Medical University:
Chronic hepatitis B
Medical Ozone

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents processed this record on May 24, 2017