Lamivudine, Herbal Medicaments, Vitamin C Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B (HBV)
Recruitment status was Active, not recruiting
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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. |
- 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.
- 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:
|
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 |
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 .
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| Vietnam | |
| Private Clinic | |
| Hồ Chí Minh, Ho Chi Minh City, Vietnam, 70000 | |
| 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 May 21, 2013