Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
Primary Purpose
HBV Carrier
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Standard Dose Spirulina Platensis
Zero Spirulina Platensis
Double Dose Spirulina Platensis
Sponsored by
About this trial
This is an interventional treatment trial for HBV Carrier
Eligibility Criteria
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.
Sites / Locations
- WanFangHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Standard Dose Spirulina Platensis
Zero Spirulina Platensis
Double Dose Spirulina Platensis
Arm Description
Spirulina platensis pill/500mg, 3 pills before each meal /6 pills per day
Spirulina platensis pill/500mg, 6 pills before each meal /12 pills per day
same as usual, non pill taken
Outcomes
Primary Outcome Measures
HBsAg(quantitative)
Secondary Outcome Measures
Full Information
NCT ID
NCT02953600
First Posted
October 27, 2016
Last Updated
November 10, 2016
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02953600
Brief Title
Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
Official Title
Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HBV Carrier
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Dose Spirulina Platensis
Arm Type
Experimental
Arm Description
Spirulina platensis pill/500mg, 3 pills before each meal /6 pills per day
Arm Title
Zero Spirulina Platensis
Arm Type
Active Comparator
Arm Description
Spirulina platensis pill/500mg, 6 pills before each meal /12 pills per day
Arm Title
Double Dose Spirulina Platensis
Arm Type
Active Comparator
Arm Description
same as usual, non pill taken
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Dose Spirulina Platensis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Zero Spirulina Platensis
Intervention Description
the zero pill-taken group is a comparison for two other groups.
Intervention Type
Dietary Supplement
Intervention Name(s)
Double Dose Spirulina Platensis
Intervention Description
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.
Primary Outcome Measure Information:
Title
HBsAg(quantitative)
Time Frame
treatment continues for 6 months and checks if HBsAg(quantitative) goes down or remain at the same.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Shun Wu, Dr
Phone
886229307930
Ext
7923
Email
mswu@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shun Wu, Dr
Organizational Affiliation
WanFangHospital
Official's Role
Study Director
Facility Information:
Facility Name
WanFangH
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Ching Chung
Phone
+886229307930
Ext
7923
Email
104494@w.tmu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Cyanobacteria Patients With Chronic Hepatitis B Surface Antigen Quantitative Concentration
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