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Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration

Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02953600
Enrollment
72
Registered
2016-11-03
Start date
2016-11-30
Completion date
2017-08-31
Last updated
2016-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBV Carrier

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTStandard Dose Spirulina Platensis

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.

OTHERZero Spirulina Platensis

the zero pill-taken group is a comparison for two other groups.

DIETARY_SUPPLEMENTDouble Dose Spirulina Platensis

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.

Sponsors

Taipei Medical University WanFang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* In patients with chronic hepatitis B of taking oral antiviral drugs , and the virus has been detected is less than the amount (HBV DNA \<20 IU / ml), aged between 20 years to 75 years .

Exclusion criteria

* Patients were allergic to seafood.

Design outcomes

Primary

MeasureTime frame
HBsAg(quantitative)treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.

Countries

Taiwan

Contacts

Primary ContactMing Shun Wu, Dr
mswu@tmu.edu.tw886229307930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026