Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B (EMOTCHB)
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|ClinicalTrials.gov Identifier: NCT01342185|
Recruitment Status : Unknown
Verified October 2012 by guoyabing, Nanfang Hospital of Southern Medical University.
Recruitment status was: Enrolling by invitation
First Posted : April 27, 2011
Last Update Posted : October 18, 2012
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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
- HBV DNA [ Time Frame: week 12 ]To demonstrate the percentage of patients achieving HBV DNA＜1000copies/mL or decreased 100 times at week 12.
- HBeAg [ Time Frame: week12 ]Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342185
|GuangZhou, Guangdong, China, 510000|
|Principal Investigator:||yabing guo, professor||Nanfang Hospital of Southern Medical University|