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Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B (EMOTCHB)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by guoyabing, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342185
First Posted: April 27, 2011
Last Update Posted: October 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tianyi medical instruments limited company, Ningbo, China
Information provided by (Responsible Party):
guoyabing, Nanfang Hospital of Southern Medical University
February 16, 2011
April 27, 2011
October 18, 2012
March 2010
July 2013   (Final data collection date for primary outcome measure)
HBV DNA [ Time Frame: week 12 ]
To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.
Same as current
Complete list of historical versions of study NCT01342185 on ClinicalTrials.gov Archive Site
HBeAg [ Time Frame: week12 ]
Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.
Same as current
Not Provided
Not Provided
 
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
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Hepatitis B
  • 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 Name: 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 Name: 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 Name: ganlixin capsules
  • Experimental: Medical ozone therapy with tianyi
    Intervention: Device: medical ozone therapy with tianyi
  • Active Comparator: medical ozone therapy with humares
    Intervention: Device: medical ozone therapy with humares
  • Placebo Comparator: Diammonium glycyrrhizinate Capsules
    Intervention: Drug: Diammonium glycyrrhizinate Capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
189
July 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient has a history of hemorrhagic or hemolysis disease;
  2. Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease;
  3. Patient is co-infected with HIV or HCV;
  4. Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months;
  5. Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation;
  6. Pregnancy;
  7. Current alcohol or drug abuse;
  8. Difficulty to draw blood through veins;
  9. Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml;
  10. Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance;
  11. Patient is enrolled in any other clinical trials.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01342185
a4xr2dv8
Yes
Not Provided
Not Provided
guoyabing, Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
Tianyi medical instruments limited company, Ningbo, China
Principal Investigator: yabing guo, professor Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP