• Journal of Korean Medicine Rehabilitation
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• v.29 no.1
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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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• v.27 no.4
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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.

• The Korean Journal of Applied Statistics
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• v.26 no.4
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• pp.675-686
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• 2013

The Korea Food and Drug Administration(KFDA) recommends the use of a $2{\times}2$ crossover design to assess the bioequivalence of generic drugs. However, a standard $2{\times}2$ crossover design for bioequivalence trials is often considered problematic due to ethical and economic issues as highly variable drugs are usually required by large numbers of subjects when designing the trial. To overcome this problem a $2{\times}4$ crossover design has been a recommended option as per US regulations; in addition, a $2{\times}3$ crossover design has also recently drawn special attention as an efficient alternative. The current KFDA regulation requires an ANOVA table for every bioequivalence study; however, ANOVA tables of $2{\times}4$ and $2{\times}3$ crossover designs have never been published in the literature. This study shows the derivation of tables of analysis of variance for a $2{\times}4$ cross-over design and a $2{\times}3$ cross-over design. We also suggest a sample size formulas for $2{\times}2$, $2{\times}4$ and $2{\times}3$ crossover designs to provide information on the selection of efficient designs for highly variable drugs.

• Journal of Nutrition and Health
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• v.42 no.5
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• pp.442-452
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• 2009

Smoking has been known to exacerbate the initiation and propagation of oxidative stresses. Efforts have been made to reduce the smoking-induced oxidative stresses using commercial dietary supplements. Propolis is the resinous substance collected by bees from the leaf buds and bark of trees, especially poplar and conifer trees. In this trial, we examined whether a daily supplementation of 800 mg propolis can protect endogenous lymphocytic DNA damage and modulate antioxidative enzyme activities and the level of antioxidant vitamin in smokers using a placebo-controlled, doubleblinded cross-over trial. After two weeks of running-in period, 29 smokers (mean age 34.38 ${\pm}$ 1.73) received 6 tablets/day of either propolis or placebo pills for 4 weeks. After 2 weeks of washout period the subjects switched they pills for cross-over study. The degree of DNA damage (assessed by tail DNA, tail length and tail moment) was not significantly changed with propolis intake or placebo intake. Similarly, total antioxidant status (TAS) remained at the same level regardless of the treatment. Erythrocyte catalase, glutathione peroxidase (GSH-Px), superoxide dismutase (SOD), plasma vitamin C and tocopherol level did not differ before and after propolis treatment, and did not differ between treatments. Putting all these results together, we would suggest that it is still too early to claim that propolis possess antioxidative activities.

• Journal of Nutrition and Health
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• v.30 no.9
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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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• v.38 no.1
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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.

• Journal of the Korean Society of Physical Medicine
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• v.18 no.2
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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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• v.13 no.2
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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.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.19 no.2
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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.

• Therapeutic Science for Rehabilitation
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• v.7 no.3
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• pp.79-88
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• 2018

Objective : Localized vibration has been shown to have a positive effect on recovery of upper-limb motor function in patients with hemiparetic stroke, but there has been little research on kinematic analysis for qualitative changes in movement. This study investigated kinematic changes in elbow motion during reaching after localized vibration in persons with hemiparetic stroke. Methods : This study used a one-group, cross-over trial design. Ten chronic stroke patients randomly received localized vibrations on the affected biceps brachii for 5, 10, or 20 min, at 70 Hz. Kinematic analysis of reaching was measured using a 3-D motion analysis system. Variables included peak angular velocity, time to peak angular velocity, and movement units during elbow motion. Result : Affected side elbow motion during reaching was faster, smoother, and more efficient after 20 min localized vibration. Peak angular velocity increased (p<0.05), and time to peak angular velocity (p<0.05) and the movement unit were significantly decreased (p<0.05) during elbow motion for reaching. Conclusion : Localized vibration can improve kinematic components during reaching motion in persons with hemiparetic stroke.