Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B

NCT01342185 | Unknown Phase 3 DMC

• 1 other identifier: a4xr2dv8
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

Medical ozone therapy; chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

• HBV DNA

  To demonstrate the percentage of patients achieving HBV DNA\<1000copies/mL or decreased 100 times at week 12.

  week 12

Secondary Outcomes (1)

• HBeAg

  week12

Study Arms (3)

Medical ozone therapy with tianyi

EXPERIMENTAL

Device: medical ozone therapy with tianyi

medical ozone therapy with humares

ACTIVE COMPARATOR

Device: medical ozone therapy with humares

Diammonium glycyrrhizinate Capsules

PLACEBO COMPARATOR

Drug: Diammonium glycyrrhizinate Capsules

Interventions

medical ozone therapy with tianyi DEVICE

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.

Also known as: ozone instrument made in China: TianYi

Medical ozone therapy with tianyi

medical ozone therapy with humares DEVICE

Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.

Also known as: ozone instrument made in Germany: Humares

medical ozone therapy with humares

Diammonium glycyrrhizinate Capsules DRUG

Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.

Also known as: ganlixin capsules

Diammonium glycyrrhizinate Capsules

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Tianyi medical instruments limited company, Ningbo, China: collaborator

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Glycyrrhizic Acid

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• yabing guo, professor

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: April 27, 2011
• Study Start: March 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

CN (1)