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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| First Received Date ICMJE | September 4, 2010 | ||||
| Last Updated Date | September 9, 2010 | ||||
| Start Date ICMJE | September 2010 | ||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01198860 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Effectiveness of Vitamin C, Herbal with Lamivudine [ Time Frame: After 36 months ] [ Designated as safety issue: Yes ]
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Lamivudine, Herbal Medicaments, Vitamin C Treatment on HBeAg Positive or HBeAg Negative in Chronic Hepatitis B | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 . |
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| Condition ICMJE | Chronic Hepatitis B | ||||
| Intervention ICMJE | 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:
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| Study Group/Cohort (s) | 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(+).
Intervention: Drug: Chronic Hepatitis B |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 1 | ||||
| Estimated Completion Date | September 2010 | ||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Vietnam | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01198860 | ||||
| Other Study ID Numbers ICMJE | HBsAg 07-10 - Private Clinic | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Collaborator Minh Đức Trần, Private Clinic | ||||
| Study Sponsor ICMJE | Triệu, Nguyễn Thị, M.D. | ||||
| Collaborators ICMJE | General Clinic | ||||
| Investigators ICMJE |
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| Information Provided By | Triệu, Nguyễn Thị, M.D. | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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