Lamivudine, Herbal Medicaments, Vitamin C Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B (HBV)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Triệu, Nguyễn Thị, M.D..
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
General Clinic
Information provided by:
Triệu, Nguyễn Thị, M.D.
ClinicalTrials.gov Identifier:
NCT01198860
First received: September 4, 2010
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

Phyllanthus Cantoniensis Hornem - Herba Adenosmatis Caerulei - Herba Eclipta - Vitamin C combination plus lamivudin 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 in management or public health policy.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Chronic Hepatitis B
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Lamivudine 100mg - Phyllanthus Cantoniensis Hornem 300mg - Herba Adenosmatis Caerulei 150mg - Herba Eclipta 150mg, Vitamin C 500 mg Daily is Effective in the Long-term Treatment of Chronic Hepatitis B.

Resource links provided by NLM:


Further study details as provided by Triệu, Nguyễn Thị, M.D.:

Primary Outcome Measures:
  • Effectiveness of Vitamin C, Herbal with Lamivudine [ Time Frame: After six months ] [ Designated as safety issue: Yes ]
    . Proportion of patients with complete response (normalisation of SGPT< ( 7 - 40 ) U/L and disappearance of HBV DNA, lower limit of detection), at month 06.


Secondary Outcome Measures:
  • Effectiveness of Vitamin C, Herbal with Lamivudine [ Time Frame: After 36 months ] [ Designated as safety issue: Yes ]
    • Histological improvement at month 06.
    • Proportion of patients with complete response post-treatment (at month 12).
    • Found no cases of HBV resistance to lamivudine after 36 months of treatment.
    • HBsAg seroconversion.
    • Safety of treatment.


Enrollment: 1
Study Start Date: September 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CHRONIC HEPATITIS B
Selective patients treated with Lamivudin 100mg, Entercavir 0.5 mg , Adefovir 10mg, Thymomodulin, more than one years after, diagnosis is still on the threshold HBV DNA :(> 10,000 copies / ml) and HBeAg(-) or HBV DNA :(> 100,000 copies / ml) and HBeAg(+).
Drug: Chronic Hepatitis B

Drug:

Lamivudine/ 100mg daily Phyllanthus Cantoniensis Hornem/300mg daily Herba adenosmatis caerulei/150mg daily Herba Eclipta /150mg daily Vitamin C / 500mg daily

Other Names:
  • Lamivudine 100mg
  • Vitamine C
  • Phyllanthus cantoniensis Hornem
  • Herba adenosmatis caerulei
  • Herba Eclipta

Detailed Description:

Recent studies have proved Phyllanthus Cantoniensis Hornem - Herba Adenosmatis Caerulei - Herba Eclipta - Vitamin C combination plus lamivudin 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 or eradication of HBV infection and to arrest or ameliorate HBV-related liver damage.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Selective patients treated with Lamivudin 100mg, Entercavir 0.5 mg , Adefovir 10mg, Thymomodulin, more than one years after, diagnosis is still on the threshold HBV DNA :(> 10,000 copies / ml) and HBeAg(-) or HBV DNA :(> 100,000 copies / ml) and HBeAg(+).

Agree continue treatment a new for chronic hepatitis B with Lamivudine - Phyllanthus - Adenosmatis - Ecliptae - Vitamin C .

Criteria

Inclusion Criteria:

  • Males and females ≥ 18 years of age with chronic 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 previously received LAM for at least 06 months.
  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01198860

Locations
Vietnam
Private Clinic
Hồ Chí Minh, Ho Chi Minh City, Vietnam, 70000
Sponsors and Collaborators
Triệu, Nguyễn Thị, M.D.
General Clinic
Investigators
Study Director: Nguyễn Thị Triệu, Bachelor Private Clinic
  More Information

No publications provided

Responsible Party: Collaborator Minh Đức Trần, Private Clinic
ClinicalTrials.gov Identifier: NCT01198860     History of Changes
Other Study ID Numbers: HBsAg 07-10 - Private Clinic
Study First Received: September 4, 2010
Last Updated: September 9, 2010
Health Authority: Vietnam: Ho Chi Minh City Health Service

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Vitamins
Lamivudine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 31, 2014