Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

— EMOTCHB  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01342185
• Other study ID #: a4xr2dv8
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: February 16, 2011
• Last updated: October 17, 2012
• Start date: March 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2012
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 189
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Device:
• 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.
• medical ozone therapy with humares
Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as Arm?.

Drug:
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital	GuangZhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Tianyi medical instruments limited company, Ningbo, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA	To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.	week 12	No
Secondary	HBeAg	Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.	week12	No