The Efficacy and Safety of Black Rice Bran Extract on Immune Enhancement
NCT ID: NCT04940910
Last Updated: 2021-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2021-02-22
2021-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Black rice bran extract group
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal(1.52 g/day, Black rice bran extract 1 g/day)
Black rice bran extract
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
Placebo group
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal(1.52 g/day, Black rice bran extract 0 g/day)
Placebo
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
Interventions
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Black rice bran extract
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
Placebo
2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
Eligibility Criteria
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Inclusion Criteria
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice
Exclusion Criteria
* Those who received influenza vaccination within 3 months before first intake of intervention
* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results
* Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
* Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
19 Years
75 Years
ALL
Yes
Sponsors
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Chonbuk National University Hospital
OTHER
Responsible Party
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Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Locations
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Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JARM-IE-BRBE
Identifier Type: -
Identifier Source: org_study_id
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