Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B (HBV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01198860
Expanded Access Status : Available
First Posted : September 10, 2010
Last Update Posted : October 11, 2017
Information provided by (Responsible Party):
Triệu, Nguyễn Thị, M.D.

Brief Summary:

Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments.

Has stronger effect on immune system, effective good against HBV replication. This is a substantial new insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance and perfect in management or public health policy.

Condition or disease Intervention/treatment
CHRONIC HEPATITIS B Drug: CTH Chronic Hepatitis B

Detailed Description:

Recent studies have proved Phyllanthus Urinaria - Adenosmatis Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments. To made a clean jobs for HBV - DNA in the patient's body - hope this is a new step of medicine, will no longer exist phrase "chronic HBV infection " Methods of safety, therapeutic effect on expected cost savings should easily apply to everyone everywhere in the world. According to the investigation and must be called , Chronic HBV infection is an important worldwide cause of morbidity, mortality and source of potential new infections. There are an estimated 350 million carriers of HBV in the world. In China, Southeast Asia and sub-Saharan Africa, as many as 10-15% of the population are chronically infected. In North America and Northern Europe, infection and carrier rates are much lower, usually below 1%. Intermediate carrier rates of 1-5% are found in Southern Europe (e.g., Italy, Greece and Spain), parts of South and Central America, the Middle East and Japan. Persistent infection develops in over 90% of perinatally infected children and in 3-10% of people who become infected after the age of 6 years. Worldwide, it has been estimated that more than one million people die annually due to HBV-related end stage diseases such as cirrhosis and hepatocellular carcinoma.

The goal of antiviral therapy for hepatitis B is to reduce a patient's risks for progressive liver disease through prolonged suppression and eradication of HBV infection and to arrest or ameliorate HBV-related liver damage.

Study Type : Expanded Access
Official Title: Tenofovir Disoproxil Fumarat 300 mg - Phyllanthus Urinaria 300mg - Adenosma Glutinosum 150mg - Eclipta Prostrata 150mg, Ascorbic Acid 500 mg Daily is Effective in the Long-term Treatment of Chronic and Acute Hepatitis B.

Intervention Details:
  • Drug: CTH Chronic Hepatitis B


    • Tenofovir/ 300mg daily
    • Phyllanthus Urinaria/300mg daily
    • Adenosma Glutinosum/150mg daily
    • Eclipta Prostrata/150mg daily
    • Ascorbic Acid / 500mg daily
    Other Names:
    • - Ascorbic Acid
    • - Phyllanthus Urinaria
    • - Adenosma Glutinosum
    • - Eclipta Prostrata
    • - Tenofovir

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Inclusion Criteria:

  • Males and females ≥ 18 years of age with chronic and acute hepatitis B.
  • Hepatitis B surface antigen (HBsAg)(+) for a minimum of 6 months prior to entry.
  • Hepatitis B envelope antigen (HBeAg)(+) or (-) at baseline.
  • Patients having treated or untreated
  • Patients with compensated liver function (Child-Pugh score ≤ 6).
  • Informed writted consent.

Exclusion Criteria:

  • Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. or cytokine-based therapies with possible activity in hepatitis B disease within 6 months prior to study screening.
  • Organ or bone marrow transplant recipients.
  • Evidence of active liver disease to operate.
  • Received immunoglobulins, interferon or other immune e to other causes (e.g., Wilson's disease, hemochromatosis, autoimmune hepatitis, hepatitis C, hepatitis D or HIV.)
  • Patients taking parenteral (intravenous or intramuscular or subcutaneous) or oral steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the course of the study.
  • Clinically relevant alcohol or drug use or history of alcohol or drug use considered by the investigator to be sufficient to hinder compliance with treatment, follow up procedures or evaluation of adverse events.
  • Hepatocellular carcinoma.
  • Serious concurrent medical illness other than hepatitis B.
  • History of hypersensitivity to nucleoside analogues.
  • Women of childbearing potential not practising adequate contraception.
  • Pregnancy or lactation.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01198860

Contact: Nguyễn Thị Triệu, Master (84)0903640722
Contact: Trần Minh Đức, Dr. (84)0937244572

Private Clinic TRAN MINH DUC
Hồ Chí Minh, Ho Chi Minh City, Vietnam, 70000
Contact: Nguyễn Thị Triệu, Master    ( 84 ) 0903640722   
Contact: Trần Minh Đức, Dr.    ( 84 )0937244572   
Principal Investigator: Nguyễn Thị Triệu, Master         
Sponsors and Collaborators
Triệu, Nguyễn Thị, M.D.
Study Director: Nguyễn Thị Triệu, Master Tran Minh Duc, Dr.

Responsible Party: Triệu, Nguyễn Thị, M.D., Trần Minh Đức Identifier: NCT01198860     History of Changes
Other Study ID Numbers: HBsAg 07-10 - Private Clinic
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Triệu, Nguyễn Thị, M.D.:

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Ascorbic Acid
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Protective Agents
Physiological Effects of Drugs
Growth Substances