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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Device: medical ozone therapy with tianyi; Drug: Diammonium glycyrrhizinate Capsules; Device: medical ozone therapy with humares

Study type: Interventional

Funder types: Other

Identifiers

NCT01342185

a4xr2dv8

Details and patient eligibility

About

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

Full 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.

Enrollment: 189 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 3 patient groups, including a placebo group

Medical ozone therapy with tianyi

Experimental group

Treatment:

Device: medical ozone therapy with tianyi

medical ozone therapy with humares

Active Comparator group

Treatment:

Device: medical ozone therapy with humares

Diammonium glycyrrhizinate Capsules

Placebo Comparator group

Treatment:

Drug: Diammonium glycyrrhizinate Capsules