Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tainan, Taiwan
- Recruiting
- WanFangH
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Contact:
- Shu-Ching Chung
- Phone Number: 7923 +886229307930
- Email: 104494@w.tmu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Standard Dose Spirulina Platensis
Spirulina platensis pill/500mg, 3 pills before each meal /6 pills per day
|
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.
|
|
Active Comparator: Zero Spirulina Platensis
Spirulina platensis pill/500mg, 6 pills before each meal /12 pills per day
|
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.
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Active Comparator: Double Dose Spirulina Platensis
same as usual, non pill taken
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the zero pill-taken group is a comparison for two other groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HBsAg(quantitative)
Time Frame: treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.
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treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.
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Collaborators and Investigators
Investigators
- Study Director: Ming Shun Wu, Dr, WanFangHospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201608026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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