• Journal of Pharmacopuncture
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• v.12 no.3
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• pp.31-40
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• 2009

Objective : This study was to investigate the effects of distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture have on the autonomic nervous system. Methods : 60 healthy male volunteers were divided into three groups which consist of two experimental groups such as Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture, and a control group. Study design was a randomized, placebo-controlled, double-blind clinical trial. 20 subjects in experimental group were injected distilled Cervi Pantotrichum Cornu Pharmacopuncture at $GB_{21}$(Kyonjong), 20 subjects in other experimental group were injected distilled Zizyphi Spinosi Semen Pharmacopuncture and 20 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). One volunteer of each groups were excluded from analysis because of error during measuring HRV. At the end of the study 57 volunteers completed HRV analysis. HRV was measured by QECG-3:LXC3203(LAXTHA Inc. Korea) at P0, P1, P2, P3, P4, P5 and P6 and its time-course dependent change in each group was analyzed using paired t-test, and the difference of HRV fluctuation among two experimental group and a control was evaluated by one way ANOVA(p<0.05). Results : A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased only at 20 minutes after injection. SDNN was significantly increased from 15 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Complexity was significantly decreased at 10, 15 and 30 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, pNN50 was significantly decreased at 15, 20 and 25 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture showed significant difference on HRV index and pNN50 at 5 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(VLF) After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at 15 and 30 minutes after injection. Ln(VLF) was significantly increased at 10, 15 and 30 minutes after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Ln(VLF) was significantly increased only at 30 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture showed significant difference on Ln(TP) after 5 minutes of injection. Conclusions : Our results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

• Korean Journal of Food Science and Technology
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• v.38 no.5
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• pp.717-719
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• 2006

A randomized, double blind, placebo-controlled human intervention study involving 62 healthy volunteers was performed to investigate the effects of Keumsa sangwhang (Phellinus linteus) mushroom extracts (KPLE) on natural killer (NK) cell activity in peripheral blood. The volunteers were randomly distributed into two groups, one receiving KPLE (3.3 g/day) and the other a placebo by oral administration for 8 weeks. In this study, the number of NK cells did not increase with KPLE administration, however the cytotoxic activity of NK cells against the Jurkat leukemia cell line increased significantly. This result suggests that administration of KPLE induces cell-mediated immunity by increasing NK cell activity in humans.

• Osteoporosis and Sarcopenia
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• v.2 no.4
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• pp.228-237
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• 2016

Objective: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin $D_3$ after intramuscular injection in Korean adults with vitamin D deficiency. Method: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ${\geq}19$ and <65 years of age were randomly allocated to either the vitamin $D_3$ or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin $D_3$ 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mLon week 12 or thereafter, a repeat injection was administered. Results: After a single intramuscular injection of vitamin $D_3$ to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 12 weeks was 46.4% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). The proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 24 weeks was 73.2% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin $D_3$ injection was $12.8{\pm}8.1$ and $21.5{\pm}8.1ng/mL$, respectively, in the vitamin $D_3$ group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin $D_3$ group but no change in the placebo group. Conclusion: Intramuscular injection of vitamin $D_3$ 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.

• The Korea Journal of Herbology
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• v.38 no.2
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• pp.1-7
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• 2023

Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.

• The Journal of Pediatrics of Korean Medicine
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• v.27 no.1
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• pp.36-49
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• 2013

Objectives The goal of this review is to investigate clinical and experimental studies on external application treatment for atopic dermatitis in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Methods Electronic researches were performed with KTKP, OASIS, National Assembly Library, Korean Medicine Database, KISS, DBpia, and KISTI. Results and Conclusions In Twenty six studies, the numbers of clinical and experimental studies are respectively 10 (38.46%) and 16 (61.54%). The numbers of studies that used herbal complex were 20 (76.92%), and out of that, 6 studies had used a single herbal medicine (23.08%). The external application with oriental medicine for the atopic dermatitis used with Phellodendri Cortex (7), Sophorae Radix (6), Scutellariae Radix (6), Lonicerae Flos (5), Coptidis Rhizoma (5) and so on. Among the clinical studies, the 5 studies were double-blind and randomized-controlled study (50%). The numbers of studies that used Hanifin and Rajka Diagnostic Criteria (1980) were 6 (60%), and that used the Diagnostic Criteria in Korean Atopic Dermatitis (2005) were 4 (40%). Among the clinical studies, categories to evaluate of atopic dermatitis are respectively SCORAD Index (80%), Total IgE (80%), Eosinophil count (70%) and so on. All of the clinical studies (100%) showed a statistically significant decline in atopic dermatitis according to the SCORAD Index, Modified SCORAD Index, the Clinic index score. Among the experimental studies, the numbers of studies that used NC/Nga mice were 9 (56.25%), and out of that 5 studies used BALB/c mice (31.25%). Most of the studies (68.75%) used DNCB as allergy inducing materials. The scales for evaluation of atopic dermatitis were Clinical skin severity score, Histopathologic examination, Immunohematologic examination, safety test and so on. In 12 cases (75%) of experimental studies, the IgE level of experimental group showed a statistically significant decline after using external application. In 8 study cases (50%), Clinical skin severity score of experimental group showed a statistically significant decline after using external application.

• Journal of Preventive Medicine and Public Health
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• v.37 no.4
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• pp.381-389
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• 2004

Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

• Journal of Korean Medicine Rehabilitation
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• v.31 no.4
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• pp.117-127
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• 2021

Objectives Previously, we demonstrated that a 5% ethanol extract of unripe Rubus coreanus (5-uRCK) and ellagic acid has hypocholesterolemic and antiobesity activity in high-fat diet-fed animals. Therefore, we conducted a clinical study on the anti-obesity effect of 5-uRCK in 140 Korean adults (aged 19-70 years, body mass index (BMI) ≥25 kg/m²). Methods The participants were randomly assigned to two groups and were administered the placebo (n=70) or 5-uRCK extract (800 mg, n=70) daily for 12 weeks. The subjects were instructed to maintain their usual dietary intake and normal physical activity. Anthropometrics, body composition (dual-energy X-ray absorptiometry), and blood parameters were compared between the two groups. Results Average body weight and BMI did not show any significant changes; however, changes in upper body fat mass between the two groups was significantly different, as determined using analysis of covariance adjusted for baseline of percent body fat and drinking units. Moreover, Although not significant, the trunk fat mass and percent trunk fat tended to decrease after 5-uRCK supplementation. There was no significant difference in other laboratory biomarkers between the two groups. All safety parameters were within normal ranges in the both group. Conclusions In the present study, 5-uRCK significantly reduced upper body fat in obese subjects after 12 weeks, which indicates that it may help improve android-type obesity. Furthermore, the supplement is safe and well tolerated.

• Korean Journal of Food Science and Technology
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• v.53 no.1
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• pp.72-77
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• 2021

Silkworms have traditionally been used to produce silk and textiles. However, steamed and freeze-dried mature silkworm larval powder (SMSP) contain large amounts of amino acids, vitamins, and essential minerals. In this study, we investigated the potential of SMSP as a hangover-relieving agent. Thirty individuals who met the selection criteria and exclusion criteria were included in the study and subsequently underwent a double-blind, randomized, placebo-controlled, cross-design human application test. Importantly, the test product containing SMSP (CKDHC) was proven to alleviate hangovers through a significant reduction in the plasma concentration of acetaldehyde in the context of an alcohol-induced hangover model. In particular, from 0.5 h after SMSP intake, the blood acetaldehyde concentration (mg/L), area under the time curve (AUC; indicating the degree of bioabsorption of blood acetaldehyde), and the highest blood acetaldehyde concentration (Cmax) were reduced. Altogether, these results suggest that the test product (CKDHC) exhibits an accelerated hangover-relieving effect.

• Korean Journal of Clinical Pharmacy
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• v.15 no.1
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• pp.9-20
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• 2005

Cholestatic liver disease is a frequent complication of prolonged parenteral nutrition, especially in premature infants. Numerous factors have been cited as contributing to TPN associated cholestasis. However the exact etiology remains obscure. Ursodeoxycholic acid (UDCA) has been reported to be beneficial far children and adults with various chronic cholestatic liver disease. The aim of this prospective, randomized, double-blind, placebo-controlled study was to determine the preventive effects of UDCA administration during TPN. Seventeen pediatric patients (8 boys and 9 girls) undergoing TPN were assigned randomly to two groups, UDCA and placebo group. UDCA group (n=9) received 15 mg/kg/day UDCA and placebo group (n=8) received 15 mg/kg/day placebo enterally during the TPN period. Liver function tests (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase) were per-formed before TPN and weekly or three times a week. The patients' weights, complete blood count, composition of TPN, and the infusion rate of TPN and lipid were monitored everyday. Calcium and phosphate were monitored twice a week. Between the UDCA and placebo groups, there were no differences in weight at the onset of TPN, birth weight, duration of TPN, respiratory distress syndrome associated with prematurity, age at the onset of TPN, gestational age, the number of days the patients received antibiotics, the number of patients received enteral nutritions and the composition of TPN. In contrast, there was a significant difference between the UDCA and placebo groups in alanine aminotransferase levels during TPN. It doesn't seem that UDCA administration during TPN correlates directly with improvement of liver function. But the preventive administration of UDCA may be effective in reducing liver enzyme, alanine aminotransferase and has no adverse effects.

• Journal of Pharmacopuncture
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• v.11 no.1
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• pp.55-69
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• 2008

Objective : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. Method : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. 1 healthy volunteers consisted of 31 subjects in experiment(distilled Wild Ginseng Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Wild Ginseng Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 11 subjects(7 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 24 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t-test(in group) and Student t-test(between two groups) were used to verify the result. Result : 1. After distilled Wild Ginseng Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low after 5 minute, HRV index is significantly high after 10 minute and pNN50 is significantly low after 5 minute. 2. SDNN of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25minute, and pNN50 of distilled Wild Ginseng Herbal Acupuncture Group significantly decreased from 10minute to 15minute and 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Wild Ginseng Herbal Acupuncture injection, Ln(TP), Ln(VLF) and Ln(LF) are significantly high after 5 minute, normalized LF is significantly high after 5 minute and normalized HF is significantly low after 5 minute. 4. Ln(TP) and Ln(VLF) of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25 minute compared with those of Normal Saline group. Conclusion : The results suggest that distilled Wild Ginseng Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.