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