Back to resultsEfficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B (EMOTCHB)
Primary Purpose
Chronic Hepatitis B
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
medical ozone therapy with tianyi
medical ozone therapy with humares
Diammonium glycyrrhizinate Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Medical ozone therapy, chronic hepatitis B
Eligibility Criteria
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.
Sites / Locations
- Nanfang Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Medical ozone therapy with tianyi
medical ozone therapy with humares
Diammonium glycyrrhizinate Capsules
Arm Description
Outcomes
Primary Outcome Measures
HBV DNA
To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.
Secondary Outcome Measures
HBeAg
Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.
Full Information
NCT ID
NCT01342185
First Posted
February 16, 2011
Last Updated
October 17, 2012
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Tianyi medical instruments limited company, Ningbo, China
1. Study Identification
Unique Protocol Identification Number
NCT01342185
Brief Title
Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B
Acronym
EMOTCHB
Official Title
A Randomized, Controlled, Open-label, Multicenter Clinical Study of Treatment of Chronic Hepatitis B With TY-CZ-9999 Ozone Therapy System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Tianyi medical instruments limited company, Ningbo, China
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Medical ozone therapy, chronic hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medical ozone therapy with tianyi
Arm Type
Experimental
Arm Title
medical ozone therapy with humares
Arm Type
Active Comparator
Arm Title
Diammonium glycyrrhizinate Capsules
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
medical ozone therapy with tianyi
Other Intervention Name(s)
ozone instrument made in China: TianYi
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
medical ozone therapy with humares
Other Intervention Name(s)
ozone instrument made in Germany: Humares
Intervention Description
Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.
Intervention Type
Drug
Intervention Name(s)
Diammonium glycyrrhizinate Capsules
Other Intervention Name(s)
ganlixin capsules
Intervention Description
Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.
Primary Outcome Measure Information:
Title
HBV DNA
Description
To demonstrate the percentage of patients achieving HBV DNA<1000copies/mL or decreased 100 times at week 12.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
HBeAg
Description
Percentage of patients with HBeAg loss and HBeAg seroconversion at week 12 in patients with HBeAg positive at baseline.
Time Frame
week12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yabing guo, professor
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B
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