- Volume 29 Issue 1
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Safety of Ojeok-san Extract Powder and Soft Extract in Healthy Male Volunteers, Single Center, Randomized Controlled, Cross-over Study
오적산 혼합단미엑스산제와 혼합단미연조엑스제의 안전성 평가를 위한 단일 기관, 무작위 배정, 교차 연구
Shin, Hee-Ra;Park, Kyungtae;Yeom, Seung-Ryong;Kwon, Young-Dal
- Received : 2018.12.19
- Accepted : 2019.01.02
- Published : 2019.01.31
Objectives The purpose of this study is to evaluate the safety of Ojeok-san extract powder and soft extract in healthy male volunteers. Methods Randomized controlled, cross over study was carried out in healthy male volunteers. Total 27 of 31 subjects meeting the inclusion criteria were enrolled and three subjects for waiting were included. To each group 12 subjects were randomly allocated by random number table. Group A took the extract powder in the first period and then took the soft extract in the second period. Group B took the medicine in the opposite order. Trial was conducted through two times of hospitalizations and all subjects had a seven-days of wash out period. Vital sign and laboratory test were checked before and after the medication. The mean difference of safety evaluation variables were analyzed by paired t-test (p<0.001) or wilcoxon signed rank test (p<0.05). The mean difference between two groups were analyzed by independent t-test (p<0.05) or Mann whitney test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, There were no significant differences associated with the clinical trial drug between before and after the medication. And there was no adverse event associated with the clinical trial drug. Conclusions Both Ojeok-san extract powder and soft extract were found to be safe for healthy male volunteers.
Ojeok-san;Herbal medicine;Drug formulation;Safety;Cross over studies
- Ryu GC, Lee HW, Oh SJ, Park CJ. International competitiveness and tasks of Korean traditional medicine from the perspective of international comparison of curricula and research. Journal of Korean Institute for Health and Social Affairs. 2005;25(2):107-46.
- Lee SI. Cheon Jin Chubang Haesul. 1st ed. Seoul: Seongbosa. 1987:118.
- Yoon YK. Dongui Bangje and Chubang Haesul. 1st ed. Seoul:Uiseongdang Publishing Company. 2007:91-2.
- Bae BC. Phojun Imsang Bangjehak. 2nd ed. Seoul: Seongbosa. 1995:206.
- Statistics Korea. Health Insurance Review and Evaluation Center, Medical care drug claim status [Internet] 2018 [cited 2018 Nov 1]. Available from: URL: http://kosis.kr/statHtml/statHtml.do?orgId=354&tblId=DT_354004N_027&vw_cd=MT_OTITLE&list_id=&seqNo=&lang_mode=ko&language=kor&obj_var_id=&itm_id=&conn_path=K2.
- Lee NH, Ha HK, Lee HY, Jung DY, Choi JY, Lee JK, Shin HK. Analysis of studies on Ojeok-san for establishment of evidence based medicine. The Korean Journal of Oriental Medical Prescription. 2008;16(2):1-9.
- Lee SJ. The roll of complementary and alternative medicine in integrative medicine. Hanyang Medical Reviews. 2010;30(2):75-83. https://doi.org/10.7599/hmr.2010.30.2.75
- Shin HK. A study on the current status and prospect of CAM world market. [Internet] 2017 [cited 2018 Nov 1]. A vailable from: URL: http://www.ndsl.kr/ndsl/search/detail/report/reportSearchResultDetail.do?cn=TRKO200700008762.
- Kim NJ. Development of an insurance extension model for activating medical insurance for Korean Medicine. [Internet] 1996 [cited 2018 Nov 1]. Available from: URL: http://www.ndsl.kr/ndsl/search/detail/report/reportSearc hResultDetail.do?cn=TRKO200200052398.
- Han YJ, Lee SD, Choi JH, Park JG, Park HM, Jang IS. Effects of high frequency herbal medication administrations on the liver functions in rats. The Journal of Korean Medicine. 2006;27(1):78-90.
- Shin GW, Lee SD, Park HM, Jeon SJ, Byun JS. Effects of high frequency herbal medication administrations on the renal functions in rats. Korean Journal of Oriental Preventive Medical Society. 2005;9(1):119-33.
- Park CS, Lee SD, Park HM, Park YC. Comparison of liver, kidney, bone metal concentration in OhJeokSan-treated rats. Journal of Society of Preventive Korean Medicine. 2002;6(2):66-85.
- Min DK, Han SN, Ko SG. Effect of Ohjeoksan-decoction on brain metal level in rats. Korean Journal of Oriental Physiology and Pathology. 2002;16(5):967-75.
- Lee JY, Lee SD. Comparison of blood metal concentration in Ohjeok-san(Wuji-san) treated rats. Jounal of Korean Oriental Medicine. 2002;23(1):67-82.
- Um YR, Lee JH, Moon HJ, Park HY, Ma JY. Acute toxicity study on Ojeok-san(Wuji-san) in mice. The Journal Of Oriental Gynecology. 2009;22(3):135-42.
- Park HM, Shin HT, Lee SD. Ojeoksan's toxicological effects on pregnant rats. The Journal of Oriental Medical Preventive. 2008;12(1):89-102.
- Ha RY, Cho HS. Pros and cons of various research designs in clinical psychiatry. Korean Journal of Biological Psychiatry. 2012;19(4):159-63.
- Park BJ. Basic textbook for clinical trial participants. Cheongju:Food and Drug Administration. 2006: 69-71.