• Title/Summary/Keyword: Healthy volunteers

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Effect of Mahuang on Heart Rate Variability in Adults : a Double-Blind, Placebo-Controlled, Randomized Trial (마황 복용이 정산인의 심박변이도에 미치는 영향에 대한 무작위배정 이중맹검 임상연구)

  • Son, Dong-Hyuk;Hsing, Li-Chang;Kim, Lak-Hyung;Jeong, Seung-Il;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.105-116
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    • 2007
  • Objectives : Mahuang (Ephedra sinica), well known as an herbal medicine in the East and West, contains a relatively high percentage of ephedrine known as sympathomimetic alkaloid. We investigated the effects of Mahuang on sympathetic nervous system with heart rate variety (HRV). Time and frequency domain analysis of HRV is a noninvasive technique capable of providing information on autonomic modulation of the sinus node. Methods : We investigated 57 healthy volunteers consisting of 37 subjects in the Mahuang group and 20 subjects in the placebo group. Study form was a randomized, placebo-controlled, double-blind clinical trial. The 37 subjects in the Mahuang group took 3 Mahuang capsules (1 capsule equivalent to 2g herb Mahuang) twice a day at 10 a.m. and 2 p.,., while the 20 subjects in the placebo group took 3 placebo-capsules filled with glutinous rice powder at the same times. Mahuang medicine and placebo medicine were made into opaque capsules. We measured HRV at 3 p.m. 1 or 2 days before medication and at 3 p.m. after medication. Results : Mean-RR and SDNN of the Mahuang group significantly decreased compared with that of the placebo group, but the heart rate of the Mahuang group significantly increased compared with the placebo. HRV-Index, RMSSD and SDSD of the Mahuang group significantly decreased compared with that of the placebo group, but PNN50 of the Mahuang group significantly increased compared with placebo. Ln(TP), Ln(VLF), Ln(LF) and Ln(HF) of the Mahuang group significantly decreased compared with those of the placebo group. There were no significant differences in normalized LF, normalized HF and LF/HF ratio between the Mahuang and placebo groups. Conclusion : The results suggest that Mahuang in healthy adults tends to reduce the autonomic nervous system within the normal range.

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A Comparative Study about Cerebrovascular Reactivity from a Single Medication and Continuous Medication on Healthy Subjects (우황청심원(牛黃淸心元)의 단독투여 및 연속투여에 따른 정상인의 뇌혈관반응도의 비교연구)

  • Hwang, Jae-Woong;Kim, Chang-Hyun;Min, In-Kyu;Kim, Young-Ji;Leem, Jung-Tae;Na, Byong-Jo;Park, Sung-Wook;Park, Jung-Mi;Ko, Chang-Nam;Bae, Hyung-Sup;Jung, Woo-Sang;Moon, Sang-Kwan;Cho, Ki-Ho;Kim, Yong-Suk
    • The Journal of Korean Medicine
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    • v.30 no.1
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    • pp.95-108
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    • 2009
  • Objectives: Uwhangchungsim-won (DC) has been used in various medical fields such as stroke, hypertension, atherosclerosis, autonomic imbalance and mental instability, etc. The aim of this study was to evaluate the effect of UC on cerebral hemodynamics and estimate the appropriate dose of UC. Methods: We studied changes of hyperventilation-induced cerebrovascular reactivity and mean blood flow velocity of middle cerebral arteries (MCA) using transcranial Doppler. We observed the changes of mean blood pressure, pulse rate and expiratory CO2 using S/5 Compact Anesthesia Monitor from 10 healthy young volunteers who were administered UC twice a day in the 1 st section and then once a day in the 2nd section. Results: Mean blood pressure tended to decrease at 1 hour and pulse rate tended to decrease at 2 hours after second administration. After 2 hours, mean blood pressure rose to state before administration, but pulse rate maintained from 2 hours to 4 hours. The changes were not statistically significant. Cerebral blood flow velocity in middle cerebral artery was not statistically significant after second administration. Cerebrovascular reactivity increased from 2 hours to 4 hours after second administration. Conclusions: This study provides that administration of UC twice a day is more effective on hyperventilation-induced cerebrovascular reactivity than administration of UC once a day.

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Effect of Mood and Personality Characteristics on Psychophysiological Responses (기분과 성격특성이 정신생리적 반응에 미치는 영향)

  • Koo, Moon-Sun;Yu, Bum-Hee
    • Sleep Medicine and Psychophysiology
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    • v.8 no.1
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    • pp.59-66
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    • 2001
  • Objectives: This study examined the effect of mood and personality characteristics on psychophysiological responses measured by a biofeedback system in a normal population. Methods: Fifty healthy volunteers without any history of medical or psychiatric illnesses participated in this study. We measured the Spielberger trait anxiety inventory, Beck depression inventory, and Eysenck personality questionnaires in these subjects. Using the J & J biofeedback system, we also measured skin temperature, electrodermal response, forearm and frontal electromyography (EMG)s in 3 experimental conditions of baseline, stress, and recovery phases. Results: Trait anxiety did not show any significant correlation with psychophysiological responses except stress response in forearm EMG levels(r=0.282, p<0.05). Depressed mood was negatively correlated with forearm EMG levels in baseline (r=-0.299, p<0.05) and recovery phases(r=-0.314, p<0.05). Subjects with relatively high levels of depressed mood showed different stress and recovery responses in frontal EMG levels compared with those with relatively low levels of depressed mood (F=4.26, p<0.05). Extroverted subjects showed higher levels of forearm EMG than introverted ones in stress phase. Conclusion: Mood and personality characteristics in healthy subjects are closely related with psychophysiological responses measured by a biofeedback system. We suggest that mood and personality characteristics should be considered as important variables in analyzing abnormal psychophysiological responses in some psychiatric patients.

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The Effects of Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus.Fel Ursi Pharmacopuncture on the Heart Rate Variability (녹용약침과 웅담.우황(BU)약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Lee, Hwi-Yong;Lee, Jin-Bok;Cho, Yi-Hyun;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Acupuncture Research
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    • v.27 no.1
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    • pp.65-74
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    • 2010
  • Objectives : This study was to investigate the effects of Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi pharmacopuncture have on the autonomic nervous system. Methods : 40 healthy male volunteers were divided into two experimental groups, such as Cervi Pantotrichum Cornu Pharmacopuncture group and Bovis calculus Fel Ursi Pharmacopuncture group. Study design was a randomized, double-blind clinical trial. 20 subjects in one experimental group were injected Cervi Pantotrichum Cornu Pharmacopuncture, 20 subjects in other experimental group were injected hydrolyzed Bovis calculus Fel Ursi Pharmacopuncture at GB21(Kyonjong). We measured HRV 7 times : baseline measurement and every 5 minutes for 30 minutes after injection. The SPSS 15.0 for Windows was used to analyze the data by the paired t-test(in group) and independent sample t-test(between the groups). Results A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased all the times after injection. SDNN was significantly increased at immediate and 25 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, Mean HRV was significantly decreased all the times after injection. Complexity was significantly decreased at 15 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of Cervi Pantotrichum Cornu Pharmacopuncture, HRV index was significantly increased immediately after injection. pNN50 was significantly decreased at immediately, 20 and 25 minutes after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, HRV index was significantly increased immediately after injection. pNN50 was significantly decreased at immediate and 25 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(HF), Ln(LF), Ln(VLF) After injection of Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at immediate and 25 after injection. Ln(HF) was significantly increased all the times after injection. Ln(LF) was significantly increased at 15, 20 and 25 minutes after injection. Ln(VLF) was significantly increased at immediate and 25 minutes after injection. After injection of Bovis calculus Fel Ursi Pharmacopuncture, Ln(TP) was significantly increased at immediately and 25 after injection. Ln(LF) was significantly increased at 20 and 25 minutes after injection. Ln(VLF) was significantly increased at immediate and 25 minutes after injection. Conclusions : We results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Bovis calculus Fel Ursi Pharmacopuncture in healthy adult men tend to activate the autonomic nervous system and sympathetic nervous system within normal range.

Effects of Lactobacillus acidophilus Intake on Microfloral Changes in Human Feces (Lactobacillus acidophilus의 섭취가 사람의 분변 균총에 미치는 영향)

  • Jung, Eun-Ji;Ahn, Young-Tae;Kim, Hyun-Uk
    • Korean Journal of Food Science and Technology
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    • v.31 no.6
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    • pp.1642-1647
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    • 1999
  • Twenty healthy adult volunteers (divided into two groups) were given with 100 mL of acidophilus milk, twice a day, containing $1{\times}10^8\;cfu/mL$ of Lactobacillus acidophilus SNUL 01 or SNUL 02 originated from healthy Korean adults. The floral changes of lactobacilli, Escherichia coli, and Clostridium perfringens surviving in the feces as well as the pH of the fecal material have been studied for three weeks. Initial pH of the fecal samples before taking acidophilus milk were about pH 7 and it has been decreased to about pH 5 when the acidophilus milk was given. Population of fecal lactobacilli increased from about $10^7\;cfu/g\;to\;10^8\;cfu/g$ of fecal material after 4 days of acidophilus milk intake and the high population of lactobacilli was maintained up to 21 days. Viable cells of the fecal E. coli and C. perfringens have been decreased from about $10^7{\sim}10^8\;cfu/g\;and\;10^5{\sim}10^6\;cfu/g\;to\;10^6\;cfu/g\;and\;10^3\;cfu/g$ of fecal material after 21 days, respectively. In conclusion, continuous intake of acidophilus milk made with L. acidophilus SNUL 01 and SNUL 02 helped maintaining normal intestinal microflora, suppress harmful microorganisms.

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Bioequivalence of Cefaclor (250 mg) Capsule (세파클러 250 mg 캅셀의 생물학적 동등성)

  • Yun, MH;Kim, HS;Choi, YP;Kwon, KI
    • Korean Journal of Clinical Pharmacy
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    • v.12 no.2
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    • pp.71-75
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    • 2002
  • This study was carried out to compare the bioavailability of $Ceclex^{(R)}$ (test drug, cefaclor 250 mg/capsule) with that of $Ceclor^{(R)}$ (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean adult. The bioavailability was examined on 20 healthy volunteers who received a single dose (250 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 6hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters $(AUC_{0-6hr},\;C_{max},\;T_{max},\;AUC_{int},\;K_e,\;t_{1/2},\;Vd)$ F, and CL/F) were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the $T_{max},\;log-transformed\;AUC_{0-6hr}\;log-transformed\;C_{max},\;t_{l/2},\;V_d/F$, and CL/F. The ratios of geometric means of AUC0-6hr and $C_{max}$ between test drug and reference drug were $103.2\%\;(6.74\;{\mu}g{\cdot}hr/ml\;vs\;6.53{\pm}g{\cdot}hr/ml)\;and\;100.4\%\;(4.85\;{\mu}g\ml\;vs\;4.82\;{\mu}g/ml)$, respectively. The $T_{max}$ of test drug and reference drug were $0.9\pm0.38\;hr\;and\;0.83\pm0.34$ hrs, respectively. The $90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-6h},\;and\;C_{max}$ were log $0.98{\sim}log$ 1.08 and log $0.88{\sim}log1.15$, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug. The estimated half-life of this study was longer $(1.21\pm0.27\;hrs\;vs\;0.5-1\;hr)$, the Vd/F was larger $(68.89\pm25.72L$ vs 24.9L), and the CL/F was higher $(38.62\pm7.09\;L/hr$ vs 24.9 L/hr) than the previously reported values.

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Effects of Addition of Chicory Extract on Starch Hydrolysis in vitro and Glucose Response in Healthy Subjects (치커리추출물 첨가가 in vitro 전분가수분해율 및 정상성인의 혈당반응에 미치는 영향)

  • Lee, Jung-Sun;Shin, Hyun-Kyung
    • Korean Journal of Food Science and Technology
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    • v.29 no.6
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    • pp.1295-1303
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    • 1997
  • This study determined the effects of addtition of chicory extract on the rate of starch hydrolysis in vitro and blood glucose response in healthy subjects. The rate of corn starch hydrolysis in the presence or absence of chicory extract was determined in an in vitro enzyme/dialysis system for 2hr. Additions of dried or roasted chicory extract (5%, w/w) to corn starch solution reduced the starch hydrolysis and significantly (p<0.05) decreased the area under hydrolysis curve by 16% and 18%, respectively. Groups of five to nine volunteers underwent 60 g glucose tolerance tests (GTT) with 2.5, 5, 10, 20% (w/w) dried or roasted chicory extracts. The addition of chicory extracts significantly (p<0.05) reduced blood glucose concentration during the GTT and reduced the mean peak rise and area under blood glucose curve. The glycemic indices of all dried chicory extract, $5{\sim}20%$ roasted chicory extract groups were significantly decreased compared with glucose control. Chicory extract is therefore likely to be useful in modifying postprandial hyperglycemia.

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The Effects of distilled Astragali Radix Herbal Acupuncture on the Heart Rate Variability(HRV) (황인 약침이 정산인의 심박변이도(HRV)에 미치는 영향)

  • Lim, Sung-Taek;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.107-124
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    • 2008
  • We investigated the effects of distilled Astragali Radix Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Astragali Radix Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 61 healthy volunteers consisted of 31 subjects in experiment(distilled Astragali Radix 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 Astragali Radix Herbal Acupuncture at GB21(Kyonjong) and 30 subjects in control group were injected Normal Saline at GB21(Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 25 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. Results : I. After distilled Astragali Radix Herbal Acupuncture injection, SDNN is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute, Complexity is significantly low from 20 minute to 30minute. HRV index is significantly mgb for first 20 minute and from 25 minute to 30 minute, RMSSD is significantly high only from 15 minute to 20 minute. 2. HRV index of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, pNN50 of distilled Astragali Radix Herbal Acupuncture Group significantly decreased from 25 minute to 30 minute and RMSSD of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Astragali Radix Herbal Acupuncture injection, Ln(TP) is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute. Ln(VLF) is significantly high after 5 minute, Ln(LF) is significantly high after 15 minute and Ln(HF) is significantly high from 5 minute to 10 minute and 25 minute to 30 minute, but significantly low for first 5 minute and from 10 minute to 20 minute. Normalized LF is significantly high after 20 minute and Normalized LF is significantly low after 20 minute. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system within normal range. This result is derived from that parasympathetic nervous system was continuously activated and sympathetic nervous system was activated a little later.

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Metabolomic analysis of healthy human urine following administration of glimepiride using a liquid chromatography-tandem mass spectrometry

  • Do, Eun Young;Gwon, Mi-Ri;Kim, Bo Kyung;Ohk, Boram;Lee, Hae Won;Kang, Woo Youl;Seong, Sook Jin;Kim, Hyun-Ju;Yoon, Young-Ran
    • Translational and Clinical Pharmacology
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    • v.25 no.2
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    • pp.67-73
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    • 2017
  • Glimepiride, a third generation sulfonylurea, is an antihyperglycemic agent widely used to treat type 2 diabetes mellitus. In this study, an untargeted urinary metabolomic analysis was performed to identify endogenous metabolites affected by glimepiride administration. Urine samples of twelve healthy male volunteers were collected before and after administration of 2 mg glimepiride. These samples were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS), and then subjected to multivariate data analysis including principal component analysis and orthogonal partial least squares discriminant analysis. Through this metabolomic profiling, we identified several endogenous metabolites such as adenosine 3', 5'-cyclic monophosphate (cAMP), quercetin, tyramine, and urocanic acid, which exhibit significant metabolomic changes between pre- and posturine samples. Among these, cAMP, which is known to be related to insulin secretion, was the most significantly altered metabolite following glimepiride administration. In addition, the pathway analysis showed that purine, tyrosine, and histidine metabolism was affected by pharmacological responses to glimepiride. Together, the results suggest that the pharmacometabolomic approach, based on LC-MS/MS, is useful in understanding the alterations in biochemical pathways associated with glimepiride action.

Effects of Cordyceps militaris supplementation on the immune response and upper respiratory infection in healthy adults: a randomized, double-blind, placebo-controlled study (건강한 성인을 대상으로 면역증강 및 상기도 감염 예방에 대한 동충하초주정추출물의 유효성 평가 : 이중맹검 플라세보 대조 연구)

  • Jung, Su Jin;Hwang, Ji Hyun;Oh, Mi Ra;Chae, Soo Wan
    • Journal of Nutrition and Health
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    • v.52 no.3
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    • pp.258-267
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    • 2019
  • Purpose: Upper respiratory tract infections are major causes of the common cold throughout the world. Cordyceps militaris (C. militaris) is a well-known functional food for its anti-fatigue and immunomodulating activities. On the other hand, there are no reports on the protective effect against upper respiratory tract infections (URI). This study was a 12 week randomized, double-blind, and placebo-controlled trial in healthy volunteers. Methods: A total of 100 subjects 20 ~ 70 years of age with a history of at least two colds in the year were enrolled in the study. The participants were required to record any adverse events and rate any cold-related incidents in a diary during the investigation period. The efficacy end point was the symptoms and incidence of URI, and changes in cytokines, IgA and natural killer (NK) cell activity. Results: The Cordyceps militaris group over 12 weeks showed no significant impact on the incidence and symptomatology of URI compared to the placebo group. On the other hand, the experimental group showed significantly higher NK cell activity (p = 0.047) and IgA level (p = 0.035) compared to the placebo group. The NK-cell activity and IgA level were increased significantly by Cordyceps militaris over 12 weeks. Conclusion: The results suggest the possible beneficial immunomodulating effects, but the protective effects on URI could not be demonstrated under these conditions. Additional research will be needed to determine the efficacy and mechanisms of Cordyceps militaris function.