Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborator: Tianyi medical instruments limited company, Ningbo, China
• Treatments: Glycyrrhizic Acid

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.