Chronic Hepatitis B
Conditions
Keywords
Medical ozone therapy, chronic hepatitis B
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.
Interventions
DEVICEmedical 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.
Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.
Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.
Sponsors
Tianyi medical instruments limited company, Ningbo, China
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA | week 12 | To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL or decreased 100 times at week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBeAg | week12 | Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline. |
Countries
China
Outcome results
None listed