Herbal Formula Science (대한한의학방제학회지)

The Korean Medicine Society for the Herbal Formula Study (대한한의학방제학회)
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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

와송 추출물의 면역기능 개선 효과 및 안전성 연구: 단일기관, 무작위배정, 이중눈가림, 위약대조 비교, 임상연구 프로토콜

  • Choi, Jin Yong (Department of Internal Medicine, Korean Medicine Hospital of Pusan National University) ;
  • Choi, Jun Yong (Department of Internal Medicine, Korean Medicine Hospital of Pusan National University) ;
  • Lim, Hyun Woo (Clinical support center of functional food &drug) ;
  • Kim, Jeong (Namwon herb Co.,Ltd.) ;
  • Kim, So Yeon (Department of Internal Medicine, Korean Medicine Hospital of Pusan National University) ;
  • Han, Chang Woo (Department of Internal Medicine, Korean Medicine Hospital of Pusan National University)
  • 최진용 (부산대학교 한방병원 한방내과) ;
  • 최준용 (부산대학교 한방병원 한방내과) ;
  • 임현우 (기능성식의약임상지원센터) ;
  • 김정 (남원허브) ;
  • 김소연 (부산대학교 한방병원 한방내과) ;
  • 한창우 (부산대학교 한방병원 한방내과)
  • Received : 2017.04.25
  • Accepted : 2017.05.22
  • Published : 2017.05.31
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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.

Keywords

References

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