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Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.
Hepatocellular carcinoma (HCC) is a very severe disease in Taiwan caused 7,000 deaths per year, and majorly about 70% is caused by the chronic hepatitis B virus infection. A repeat, long-term, and severe chronic hepatitis would be more possible progressed into liver cirrhosis and HCC. As previous records, there might be 2% of chronic HBV patient would progress to liver cirrhosis, and 5% of the liver cirrhosis's patients would develop to HCC. In some cases, the HBV patient also might directly develop to HCC without liver cirrhosis phase.
Spirulina platensis is a kind of ancient livings for a 3.5 billions years, and had been recognized as a kind of space food by National Aeronautics and Space Administration(USA) because of containing numerous nutrients, especially vitamin B and beta-carotene. Beta-carotene would convert into vitamin A and help keep health vision, skin, and mucosa. With a rich source of vitamins B, especial B12 which is almost only in meals (animal livers), 1.2 grams of Spirulina platensis daily uptake would be sufficient for a human daily need, and also be a very good source for vegetarians. The investigators add the B12 test in this trial as a secondary endpoint to help monitor the absorption rates of the Spirulina platensis in human. Otherwise, the plant pigments in Spirulina platensis would also have many bioactivities on human healthy. Among these bio-activities of Spirulina platensis would contain anti-virus, anti-cancer, immune modulation, anti-inflammation, anti-oxidant, improve liver abnormality, and liver cirrhosis abilities. As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dose Spirulina Platensis | Experimental | Spirulina platensis pill/500mg, 3 pills before each meal /6 pills per day |
|
| Zero Spirulina Platensis | Active Comparator | Spirulina platensis pill/500mg, 6 pills before each meal /12 pills per day |
|
| Double Dose Spirulina Platensis | Active Comparator | same as usual, non pill taken |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Dose Spirulina Platensis | Dietary Supplement | As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg. |
| Measure | Description | Time Frame |
|---|---|---|
| HBsAg(quantitative) | treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Shun Wu, Dr | Contact | 886229307930 | 7923 | mswu@tmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ming Shun Wu, Dr | WanFangHospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WanFangH | Recruiting | Tainan | Taiwan |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 25, 2021 | |
| Reset | Feb 11, 2021 | |
| Release | Mar 18, 2021 | |
| Reset | Apr 13, 2021 | |
| Release | May 10, 2022 | |
| Reset | Feb 7, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 25, 2021 | Feb 11, 2021 | |||
| Mar 18, 2021 |
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| Zero Spirulina Platensis | Other | the zero pill-taken group is a comparison for two other groups. |
|
| Double Dose Spirulina Platensis | Dietary Supplement | As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg. Hence, the investigators would like to see if the investigators could improve sero-conversion rates much faster by taking double dose of Spirulina platensis. |
|
| Apr 13, 2021 |
| May 10, 2022 | Feb 7, 2023 |