Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B

NCT ID: NCT01342185

Last Updated: 2012-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-07-31

Brief Summary

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

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.

Conditions

Chronic Hepatitis B

Keywords

Medical ozone therapy; chronic hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical ozone therapy with tianyi

Group Type: EXPERIMENTAL

medical ozone therapy with tianyi

Intervention Type: DEVICE

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.

medical ozone therapy with humares

Group Type: ACTIVE_COMPARATOR

medical ozone therapy with humares

Intervention Type: DEVICE

Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.

Diammonium glycyrrhizinate Capsules

Group Type: PLACEBO_COMPARATOR

Diammonium glycyrrhizinate Capsules

Intervention Type: DRUG

Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

ozone instrument made in China: TianYi; ozone instrument made in Germany: Humares; ganlixin capsules

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianyi medical instruments limited company, Ningbo, China

UNKNOWN

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

guoyabing

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yabing guo, professor

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

a4xr2dv8

Identifier Type: -

Identifier Source: org_study_id