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      • 홍삼의 온열 효과와 복약 순응도에 관한 연구

        최민선,정재철,박장경,안홍엽,김동일,Choi, Min-Sun,Jeong, Jae-Cheol,Park, Jang-Kyung,Ahn, Hong-Yeop,Kim, Dong-Il 대한한방체열의학회 2009 대한한방체열의학회지 Vol.7 No.1

        Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.

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        여성의 건강관련 삶의 질과 성기능에 대한 홍삼의 효과 및 안전성 연구

        김동일(Dong-Il Kim),최민선(Min-Sun Choi),안홍엽(Hong-Yeop Ahn) 고려인삼학회 2009 Journal of Ginseng Research Vol.33 No.2

        홍삼의 여성성기능 장애 개선과 건강관련 삶의 질 개선 효과를 규명하기 위해 성기능 저하를 호소하는 만 30세 이상 45세 미만의 기혼여성을 대상으로 6주간의 기본 투약기간을 두 번 거친 총 20주 동안의 교차 임상시험을 진행한 결과 대상자들 모두에서 성기능 개선과 일반적 건강수준 향상, 삶의 질 개선 효과가 나타났으나 홍삼과 대조약의 통계적으로 유의한 차이는 나타나지 않았다. 특히 대부분의 유효성 평가 항목들이 대상약에 상관없이 1차 투약에서 좀 더 개선되는 양상을 보였고, 홍삼과 대조약의 효과가 크게 차이가 나타나지 않았다. 그러나 성욕 (desire)의 경우는 모든 대상자에서 홍삼을 복용한 경우가 대조약을 복용한 경우보다 좀 더 개선되는 양상을 보였으며, 일반적 건강수준과 삶의 질 개선에 있어서는 특히 신체적 기능 (PF)이 정신적 요소보다 홍삼을 복용한 경우에 좀 더 개선되는 양상을 보였다. 이러한 결과는 정서적 반응에 의해 높은 변동을 보일 수 있는 대상 질환의 특성 상대조약의 높은 위약효과에 의해 홍삼의 유의한 효과가 가려졌음에도 불구하고 홍삼의 보기온양 (補氣溫陽)하는 효과가 실제적으로 발휘된 것으로 생각되었으며, 신체적 건강수준 개선과 더불어 홍삼에 일정한 성기능 개선 효과가 있음을 유추 할 수 있게 하였다. 따라서 본 연구 방법을 토대로 향후 성기능장애와 같은 기능성 장애에 대한 강한 위약 효과를 고려한 좀 더 많은 수의 대상자를 포함한 장기간의 추가 임상 시험 연구가 이루어 진다면 신체적 건강과 삶의 질, 그리고 성기능 개선에 관한 홍삼의 유의한 효과를 규명할 수 있을 것이라 생각된다. To evaluate the efficacy and safety of red ginseng on women’s health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFI) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFI scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFI total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants’ sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFI, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

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