Status:
COMPLETED
A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
12-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis B patients.
Detailed Description
Total of 439 patients with chronic hepatitis B were divided according to patients' intention into two arms. 173 patients in arm I were treated with medical ozone therapy with humares which was made in...
Eligibility Criteria
Inclusion
- Male or female；
- HBsAg positive for over 6 months；
- ALT over 2×ULN, TBIL less than 80 µmol/L.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
439 Patients enrolled
Trial Details
Trial ID
NCT01887275
Start Date
March 1 2010
End Date
February 1 2013
Last Update
June 26 2013
Active Locations (1)
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1
Nanfang Hospital
Guangzhou, Guangdong, China, 510000