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

• ClinicalTrials.gov Identifier: NCT01342185
• Recruitment Status: Unknown
• First Posted: April 27, 2011
• Last Update Posted: October 18, 2012
• Sponsor: Nanfang Hospital, Southern Medical University
• Collaborator: Tianyi medical instruments limited company, Ningbo, China
• Information provided by (Responsible Party): guoyabing, Nanfang Hospital, Southern Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Hepatitis B	Device: medical ozone therapy with tianyi; Device: medical ozone therapy with humares; Drug: Diammonium glycyrrhizinate Capsules	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 189 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY-CZ-9999 Ozone Therapy System
• Study Start Date: March 2010
• Estimated Primary Completion Date: July 2013
• Estimated Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Medical ozone therapy with tianyi	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.; Other Name: ozone instrument made in China: TianYi
Active Comparator: medical ozone therapy with humares	Device: medical ozone therapy with humares; Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.; Other Name: ozone instrument made in Germany: Humares
Placebo Comparator: Diammonium glycyrrhizinate Capsules	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.; Other Name: ganlixin capsules

Outcome Measures

Primary Outcome Measures :

1. HBV DNA [ Time Frame: week 12 ]
   To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.

Secondary Outcome Measures :

1. HBeAg [ Time Frame: week12 ]
   Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Guangdong

Nanfang Hospital

GuangZhou, Guangdong, China, 510000

Sponsors and Collaborators

Nanfang Hospital, Southern Medical University

Tianyi medical instruments limited company, Ningbo, China

Investigators

• Principal Investigator: yabing guo, professor; Nanfang Hospital, Southern Medical University

More Information

• Responsible Party: guoyabing, professor, Nanfang Hospital, Southern Medical University
• ClinicalTrials.gov Identifier: NCT01342185
• Other Study ID Numbers: a4xr2dv8
• First Posted: April 27, 2011
• Last Update Posted: October 18, 2012
• Last Verified: October 2012

Keywords provided by guoyabing, Nanfang Hospital, Southern Medical University:

Medical ozone therapy; chronic hepatitis B

Additional relevant MeSH terms:

Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Chronic Disease; Disease Attributes; Pathologic Processes; Glycyrrhizic Acid; Anti-Inflammatory Agents