|
KMID : 1149220170250020135
|
|
Korean Journal of Oriental Medical Prescription
2017 Volume.25 No. 2 p.135 ~ p.143
|
|
|
Research on Immune Enhancing Effect and Safety of Wasong (Orostachys japonicus) Extract: Study Protocol for a Single Center, Randomized, Double-blind, Placebo-controlled, Clinical Trial
|
|
Choi Jin-Yong
Choi Jun-Yong
Lim Hyun-Woo
Kim Jeong
Kim So-Yeon
Han Chang-Woo
|
|
|
Abstract
|
|
|
Objectives : This trial aimed to determine if Wasong (Orostachys japonicus) extract can enhance immune system and is safe enough to be approved as a health functional food.
Methods : Total 62 people, aged 45 and older, will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial. This study will compare Wasong extract and placebo. Wasong group will take 1g of Wasong extract, once a day, for 8 weeks. Placebo group will take 1g of crystalline cellulose as placebo, once a day, for 8 weeks. Outcomes will be measured at the baseline, the end of 4th week, and 8th week. Primary outcomes are the ratio of NK cells/total lymphocytes and the ratio of T-helper cells/T-suppressor cells. Secondary outcomes are total white blood cell count, the ratio of neutrophils, lymphocytes, and monocytes in total leukocytes, the ratio of total T cells, T-helper cells, T-suppressor cells, and B cells to lymphocytes, the amount of blood IgM, IgG, IgA, and cytomegalovirus (CMV) IgG, and blood metabolite target &global analysis.
Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2016006), and registered in Clinical Research information Service, one of WHO International Clinical Trials Registry Platform (registry number: PRE20161006-002). Recruitment opened in February 2017 and is supposed to be completed by August 2017. The result is expected to be published by June 2018.
Conclusion : This trial will provide clinical information to determine the efficacy and safety of Wasong in enhancing immune system of middle-aged and older people.
|
|
|
KEYWORD
|
|
|
Wasong , Orostachys japonicus , immune system , clinical trial , protocol
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|