Efficacy and Safety Study of Ginseng Polysaccharide Extract
NCT ID: NCT02161198
Last Updated: 2014-06-11
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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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2012-09-30
2013-12-31
Brief Summary
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The focus of this trial was modulation of innate immunity, comprising cytotoxic activity of natural killer cells, phagocytic activity of polymorphonuclear leukocytes and mononuclear phagocytes, and serum levels of monocyte-derived mediators.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Y-75
volunteers receive 3 packages twice a day up to 14 weeks
Y-75
Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package
Placebo
volunteers receive 3 packages twice a day up to 14 weeks
Placebo
Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment
Interventions
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Y-75
Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package
Placebo
Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* malignancy
* active cardiovascular, renal, pulmonary, hepatic, neurological, psychiatric disease
* recent (within 4 weeks) acute respiratory tract symptoms
* immunosuppressive therapy including cytotoxic agents and corticosteroids
* medication (within 4 weeks) deemed likely to interfere with the evaluation
* history of allergic or other adverse reactions to ginseng products
50 Years
75 Years
ALL
Yes
Sponsors
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Health Biomed Inc.
INDUSTRY
Seoul St. Mary's Hospital
OTHER
Responsible Party
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Kyung-Soo Kim
Professor
Principal Investigators
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Kyung-Soo Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
Locations
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Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Countries
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References
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Cho YJ, Son HJ, Kim KS. A 14-week randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy and safety of ginseng polysaccharide (Y-75). J Transl Med. 2014 Oct 9;12:283. doi: 10.1186/s12967-014-0283-1.
Other Identifiers
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Y-75
Identifier Type: -
Identifier Source: org_study_id
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