Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B

Study Overview
=================
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.

Official Title
-----------------
A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY-CZ-9999 Ozone Therapy System

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Device: medical ozone therapy with tianyi
* Device: medical ozone therapy with humares
* Drug: Diammonium glycyrrhizinate Capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, not less than 16 years old； HBsAg positive for over 6 months； ALT over 2×ULN, TBIL less than 80µmol/L and serum HBV DNA over 10000copies/ml。 Exclusion Criteria: Patient has a history of hemorrhagic or hemolysis disease; Patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease; Patient is co-infected with HIV or HCV; Patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months; Patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation; Pregnancy; Current alcohol or drug abuse; Difficulty to draw blood through veins; Patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (HCC), or AFP over than 100ng/ml; Patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance; Patient is enrolled in any other clinical trials.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical ozone therapy with tianyi<br> | Device: medical ozone therapy with tianyi<br>* 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.<br>* Other names: ozone instrument made in China: TianYi;|
| Active Comparator: medical ozone therapy with humares<br> | Device: medical ozone therapy with humares<br>* Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.<br>* Other names: ozone instrument made in Germany: Humares;|
| Placebo Comparator: Diammonium glycyrrhizinate Capsules<br> | Drug: Diammonium glycyrrhizinate Capsules<br>* Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.<br>* Other names: ganlixin capsules;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA | To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBeAg | Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline. | week12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical ozone therapy, chronic hepatitis B