• 한방재활의학과학회지
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• 제29권1호
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• pp.63-73
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• 2019

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.

• Journal of Acupuncture Research
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• 제27권4호
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• pp.115-125
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• 2010

Objectives : The purpose of this study is to determine the effect of Bee-venom Acupuncture on upper limb spasticity control in stroke patients. Methods : Ten stroke patients with upper limb spasticity were randomly divided into two groups, a Bee-Venom Acupuncture group(group I) and a normal saline group(group II). After 1 week resting phase, this trial was used a cross-over trial. The numbers of Pharmacopuncture treatment were 3 times a week for 3 weeks. Modified Ashworth Scale(MAS), WMFT(Wolf Motor Function Test), The 10-second Test were used for evaluation of spasticity control before experiment, after 1 week, 2 weeks, 3 weeks. Results : Group I showed significant improvement(p<.05) in MAS, WMFT, The 10-second Test. But Group II showed no significant improvement(p<.05) in MAS, WMFT, The 10-second Test. The results showed significant difference in WMFT, The 10-second Test, but no significant difference in MAS between two groups. Conclusions : These results showed that Bee-venom Acupuncture might decrease upper limb spasticity and increase arm motor function in stroke patients. Further studies will be required to examine more cases in the long period for the effect on upper limb in spasticity by Bee-Venom Acupuncture.

• 응용통계연구
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• 제26권4호
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• pp.675-686
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• 2013

현재 우리나라 식품의약품안전청에서는 $2{\times}2$ 교차설계법을 기초로 제제간의 생물학적 동등성 평가를 수행하도록 규정하고 있다. 하지만 고변동성 제제의 생물학적 동등성 평가에서 $2{\times}2$ 교차설계법에 의한 시험은 지나치게 많은 피험자를 필요로 할 수 있어 윤리적이고 경제적인 고려가 필요하다는 논의가 이루어지고 있다. $2{\times}2$ 교차설계법을 대체할 수 있는 대안으로 $2{\times}4$ 교차설계법은 미국 및 유럽 등에서는 생물학적 동등성 평가에 광범위하게 사용되는 설계 방법이고, $2{\times}3$ 교차설계법도 $2{\times}2$와 $2{\times}4$ 교차설계법의 단점을 개선할 수 있는 효율적인 대안으로 관심이 많다. 본 연구에서는 $2{\times}4$와 $2{\times}3$ 교차설계법의 통계적 모형과 제시된 통계적 모형에 연계된 분산분석표를 유도한다. 현행 국내 생물학적 동등성 시험 규정에 의하면 $2{\times}4$와 $2{\times}3$ 교차설계법의 분산분석표는 반드시 제시되어야 하지만 아직 문헌상에 존재하지 않아 관련 연구에 기여할 것으로 생각된다. 또한 $2{\times}4$와 $2{\times}3$ 교차설계법에 기초한 피험자 계산을 $2{\times}2$ 교차설계법과 비교 제시하여 고변동성 제제의 생물학적 동등성 시험 연구에 적절한 시험 설계 선택에 정보를 제공한다.

• Journal of Nutrition and Health
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• 제42권5호
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• pp.442-452
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• 2009

흡연은 신체 내 산화 스트레스를 유발할 뿐 아니라 체내 항산화 상태를 악화시킨다. 따라서 흡연으로 인해 유도되는 산화 스트레스를 줄여주기 위한 여러 다양한 식품영양학적인 시도들이 되어져 왔다. 프로폴리스는 꿀벌이 자신의 생존과 번식을 유지하기 위하여 여러 식물에서 뽑아낸 수지에 꿀벌 자신의 침과 효소 등을 혼합하여 만든 천연 물질이다. 본 연구에서는 프로폴리스가 산화 스트레스로 인해 나타난 흡연자의 DNA 손상을 회복시키어 항산화 영양 상태를 개선시키는지를 보고자 하여 placebo를 사용하는 double- blind cross-over 인체시험을 수행하였다. 흡연자에게 800 mg의 프로폴리스와 placebo를 4주 섭취시킨 후 2주 washout period를 가진 뒤 다시 군을 바꾸어 교차시험으로 4주간 섭취시킨 후, comet assay에 의한 DNA 손상도 및 신체 내 항산화 효소 수준, 총 항산화력 및 항산화 비타민 상태를 분석하였다. 처음 2주 동안의 고갈기간 후에 흡연자 29명 (평균나이: 34.38 ${\pm}$ 1.73세)을 프로폴리스군과 위약군의 두 군으로 나누어 하루에 프로폴리스 또는 위약을 4주 동안 공급하였고 2주 동안의 washout 기간을 가진 후에 교차실험을 위해 대상자의 군을 바꾸어 다시 4주 동안 프로폴리스와 위약을 공급하였다. Comet assay로 분석한 대상자의 임파구 DNA 손상정도는 프로폴리스를 섭취한 군이나 위약을 섭취한 군 간에 차이를 보이지 않았으며 총 항산화 영양상태도 두 군 간에 차이가 나타나지 않았다. 적혈구 항산화 효소인 catalase, glutathione peroxidase (GSH-Px), superoxide dismutase (SOD) 활성도, 그리고 혈장 vitamin C와 tocopherol 수준도 프로폴리스군과 위약군 사이에 차이를 보이지 않았다. 따라서 흡연자에 있어서 프로폴리스의 항산화 효과를 평가하기 위해서는 앞으로 더 다양한 연구가 필요하리라고 생각된다.

• Journal of Nutrition and Health
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• 제30권9호
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• pp.1073-1083
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• 1997

This project was to compare the effects of consuming diets incorporating soybean oil , canola oil, ad palm oil on blood serum lipid patterns and fecal fat excretion in healthy human adults. The project was composed of three studies that were run concurrently . Each study was composed of a 4-day pre-trial period and two , 14-day experimental periods arranged according to a cross-over design. During the pre trial period, subjects were allowed to eat self-selected diets. During the experimental period , subjects were asked to eat constant, laboratory controlled diets in which sources of dietary fat varied . Thirty healthy , young adult subjects were fed a laboratory controlled diet incorporating soybean oil, canola oil, and palm oil. Test oils provided approximately 20% of the total dietary calories form all sources. Total dietary fat from all sources was approximately 30% of consumed calories. The highest serum total cholesterol , LDL cholesterol, VLDL cholesterol , and triglyceride values occurred when pam oil diets were eaten. However, feeding on palm oil diets resulted in the same HDL cholesterol content as with soybean oil or canola oil diets. Soybean oil diets produced numerically lower blood serum total cholesterol , LDL cholesterol, and triglycerides, and numerically higher HDL cholesterol and VLDL cholesterol than did those with canola oil. Fecal fat excretion was numerically lower with soybean oil diets than with canola diets. The highest fecal fat excretion occurred when palm oil diets were eaten.

• International Journal of Industrial Entomology and Biomaterials
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• 제38권1호
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• pp.14-17
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• 2019

Oral gargling solution has been used for the control of halitosis. The purpose of this study was to compare the level of hydrogen sulphide concentration between silk oral gargling solution and commercially available oral gargling solution. Total 21 volunteers were included in this study. The relative level of hydrogen sulphide concentration was calculated to the baseline level. In terms of the primary endpoint of the trial, relative level of hydrogen sulphide concentration was $50.84{\pm}33.19%$ with silk group, versus $71.07{\pm}21.83%$ with Listerine group ($P_{non-inferiority}=0.003$). In conclusion, the results of oral gargling with a silk protein for healthy individual were non-inferior to oral gargling with Listerine for hydrogen sulphide concentration reduction.

• 대한물리의학회지
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• 제18권2호
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• pp.1-11
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• 2023

PURPOSE: This study examined the immediate effects of applying ankle eversion taping using kinesiology tape in chronic stroke patients-design: a randomized cross-over trial. METHODS: Seventeen stroke patients underwent three interventions in random order. The subjects were initially assigned randomly to an ankle eversion taping, placebo taping, or no taping for each intervention. Ankle eversion taping was used for mechanical correction and was involved in ankle dorsiflexion and eversion. The tape was stretched by 30-40%. Placebo tapping was applied in the same form as eversion tapping but was not stretched. The balance ability was assessed using the Y-balance test. The gait ability was assessed by maximum foot pressure and time of stance phase, and gait speed was assessed using a 10 m walk test (10MWT). All measurements were performed immediately after the intervention. RESULTS: The results showed that the dynamic balance and stance phase time in chronic stroke patients was improved after ankle eversion taping. The ankle eversion taping conditions increased significantly (p < .05) compared to the placebo and no taping conditions. CONCLUSION: The application of ankle eversion taping that uses kinesiology tape instantly increased the gait ability of chronic stroke patients. On the other hand, more research will be needed to identify the long-term effects of ankle eversion taping.

• Nutrition Research and Practice
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• 제13권2호
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• pp.105-114
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• 2019

BACKGROUND/OBJECTIVES: Several previous studies have investigated whether regular walnut consumption positively changes heart-health-related parameters. The aim of this study was to investigate the effects of daily walnut intake on metabolic syndrome (MetS) status and other metabolic parameters among subjects with MetS. SUBJECTS/METHODS: This study was a two-arm, randomized, controlled crossover study with 16 weeks of each intervention (45 g of walnuts or iso-caloric white bread) with a 6 week washout period between interventions. Korean adults with MetS (n = 119) were randomly assigned to one of two sequences; 84 subjects completed the trial. At each clinic visit (at 0, 16, 22, and 38 weeks), MetS components, metabolic parameters including lipid profile, hemoglobin A1c (HbA1c), adiponectin, leptin, and apolipoprotein B, as well as anthropometric and bioimpedance data were obtained. RESULTS: Daily walnut consumption for 16 weeks improved MetS status, resulting in 28.6%-52.8% reversion rates for individual MetS components and 51.2% of participants with MetS at baseline reverted to a normal status after the walnut intervention. Significant improvements after walnut intake, compared to control intervention, in high-density lipoprotein cholesterol (HDL-C) (P = 0.028), fasting glucose (P = 0.013), HbA1c (P = 0.021), and adiponectin (P = 0.019) were observed after adjustment for gender, age, body mass index, and sequence using a linear mixed model. CONCLUSION: A dietary supplement of 45 g of walnuts for 16 weeks favorably changed MetS status by increasing the concentration of HDL-C and decreasing fasting glucose level. Furthermore, consuming walnuts on a daily basis changed HbA1c and circulating adiponectin levels among the subjects with MetS. This trial is registered at ClinicalTrials.gov as NCT03267901.

• 대한한의진단학회지
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• 제19권2호
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• pp.91-100
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• 2015

Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

• 재활치료과학
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• 제7권3호
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• pp.79-88
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• 2018

목적 : 본 연구의 목적은 뇌졸중 환자를 대상으로 환측 상지에 진동자극을 적용했을 때, 팔 뻗기 수행에서 나타나는 팔꿈치 움직임의 운동학적 변화를 관찰하기 위함이다. 연구방법 : 연구 설계는 단일집단 교차실험설계(one-group cross-over trial design)를 사용하였으며, 10명의 만성 뇌졸중 환자를 대상으로 하였다. 대상자의 환측 위팔두갈래근(biceps brachii)에 국소 진동자극을 5분, 10분, 20분 동안 무작위로 70Hz로 적용한 후, 3차원 동작분석 시스템을 통해 팔 뻗기 수행의 운동학적 움직임을 분석하였다. 종속변수에는 팔꿈치 움직임에서 나타나는 최대 각 속도, 최대 각속도까지의 시간, 움직임 단위를 포함하였다. 결과 : 팔 뻗기를 수행함에 있어서 팔꿈치의 움직임은 20분 동안 국소 진동자극을 적용하였을 때 보다 빠르고 부드러워졌으며, 효율적으로 나타났다. 팔꿈치 움직임의 최대 각속도는 증가하였고(p<0.05), 최대 각속도까지의 시간과 운동단위는 유의하게 감소하였다(p<0.05). 결론 : 국소 진동자극은 편마비 뇌졸중 환자가 팔 뻗기 움직임을 수행함에 있어 발생하는 운동학적 구성요소를 향상시킬 수 있는 효과적인 방법일 될 수 있다.