Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B (EMOTCHB)
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Purpose
The purpose of this study is to verify the effectiveness and safety of medical ozone therapy system in treatment of chronic hepatitis B.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Device: medical ozone therapy with tianyi Device: medical ozone therapy with humares Drug: Diammonium glycyrrhizinate Capsules |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- HBV DNA [ Time Frame: week 12 ] [ Designated as safety issue: No ]To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.
- HBeAg [ Time Frame: week12 ] [ Designated as safety issue: No ]Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.
| Estimated Enrollment: | 189 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| China, Guangdong | |
| Nanfang Hospital | |
| GuangZhou, Guangdong, China, 510000 | |
| Principal Investigator: | yabing guo, professor | Nanfang Hospital of Southern Medical University |
More Information
No publications provided
| Responsible Party: | guoyabing, professor, Nanfang Hospital of Southern Medical University |
| ClinicalTrials.gov Identifier: | NCT01342185 History of Changes |
| Other Study ID Numbers: | a4xr2dv8 |
| Study First Received: | February 16, 2011 |
| Last Updated: | October 17, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Nanfang Hospital of Southern Medical University:
|
Medical ozone therapy chronic hepatitis B |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Glycyrrhizic Acid Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013