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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Tianyi medical instruments limited company, Ningbo, China
Information provided by (Responsible Party):
guoyabing, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01342185
First received: February 16, 2011
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.


Condition Intervention Phase
Chronic Hepatitis B
Device: medical ozone therapy with tianyi
Device: medical ozone therapy with humares
Drug: Diammonium glycyrrhizinate Capsules
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY—CZ—9999 Ozone Therapy System

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HBV DNA [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.


Secondary Outcome Measures:
  • HBeAg [ Time Frame: week12 ] [ Designated as safety issue: No ]
    Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.


Estimated Enrollment: 189
Study Start Date: March 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medical ozone therapy with tianyi 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
Active Comparator: 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, regime as ArmⅠ.
Other Name: ozone instrument made in Germany: Humares
Placebo Comparator: Diammonium glycyrrhizinate Capsules 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342185

Locations
China, Guangdong
Nanfang Hospital
GuangZhou, Guangdong, China, 510000
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Tianyi medical instruments limited company, Ningbo, China
Investigators
Principal Investigator: yabing guo, professor Nanfang Hospital of Southern Medical University
  More Information

No publications provided

Responsible Party: guoyabing, professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01342185     History of Changes
Other Study ID Numbers: a4xr2dv8
Study First Received: February 16, 2011
Last Updated: October 17, 2012
Health Authority: China: Ethics Committee

Keywords provided by Nanfang Hospital of Southern Medical University:
Medical ozone therapy
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Glycyrrhizic Acid
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014