• Title/Summary/Keyword: Double blind test

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An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract

  • Park, Soo-Hyun;Oh, Mi-Ra;Choi, Eun-Kyung;Kim, Min-Gul;Ha, Ki-Chan;Lee, Seung-Kwon;Kim, Young-Gon;Park, Byung-Hyun;Kim, Dal-Sik;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.38 no.4
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    • pp.239-243
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    • 2014
  • Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

The Onset and Duration of Action of 0.2% Lidocaine in a One-per-Mil Tumescent Solution for Hand Surgery

  • Prasetyono, Theddeus O.H.;Lestari, Puri A.
    • Archives of Plastic Surgery
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    • v.43 no.3
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    • pp.272-277
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    • 2016
  • Background One-per-mil tumescent solution, which contains 0.2% lidocaine with 1:1,000,000 epinephrine, has been reported to be clinically effective for hand surgery under local anesthesia. However, it was lacking in its basic pharmacokinetics profile in regard to the onset of action (OOA) and duration of action (DOA). Methods A randomized, double-blind study was conducted on 12 volunteers who met the inclusion criteria from October to November 2014. All volunteers had their right and left ring finger pulps injected with either one-per-mil solution or 2% lidocaine. Semmes-Weinstein and two-point discrimination tests were used to test sensation. Visual analogue scale was recorded at the time when the finger lost its sensation and when it regained normal sensation to measure the OOA and DOA. The data were then analyzed with a paired t-test and a Wilcoxon signed-rank test. Results The OOA and DOA of 2% plain lidocaine were 1 minute and 99.67 minutes, respectively. Meanwhile, 0.2% lidocaine in a one-per-mil tumescent solution showed an OOA of 5 minutes and a DOA of 186.83 minutes. The OOA of 0.2% lidocaine in a one-per-mil tumescent solution is statistically shorter than 2% plain lidocaine (P=0.04); while its DOA is statistically longer than 2% plain lidocaine (P<0.001). Conclusions The 0.2% lidocaine in a one-per-mil tumescent solution is statistically and clinically superior to 2% plain lidocaine in achieving longer duration of local anesthesia.

The effect of Chiljehyangbuhwan on the abdominal temperature in the primary dysmenorrhea patients (칠제향부환(七製香附丸)이 원발성(原發性) 월경통(月經痛) 환자(患者)의 복부(腹部) 온도(溫度)에 미치는 영향(影響))

  • Lee, Chang-Hoon;Cho, Jung-Hoon;Jang, Jun-Bock;Lee, Kyung-Sub;Yoon, Young-Jin
    • Journal of Oriental Medical Thermology
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    • v.4 no.1
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    • pp.29-38
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    • 2005
  • Purpose: We intended to observe the relations between Chiljehyangbuhwan and abdominal temperature according to primary dysmenorrhea severity. Methods: We selected the 100 primary dysmenorrhea patients by the screening tests (first screening test-inquiry, second screening test-clinical test, additionally WHR (Waist-to-Hip ratio) by Inbody 2.0). By the fixed blocked randomization and double blind method, Chiljehyangbuhwan or placebo was administered for 1 menstration period. Finally, 69 patients remainded. Before and after administration, we measured 4 points abdominal temperature (Chon-jung(CV17), Chung-wan(CV12), Kwan-won(CV4), Chung-guk(CV3)) by DITI (DOREX Inc., USA). And then we checked the difference of temperature $({\Delta}T)$ between CV17 and CV12 / CV17 and CV4 / CV17 and CV3 / CV12 and CV4 / CV12 and CV3. After that, we compared ${\Delta}T$ with primary dysmenorrhea severity evaluated by VRS (verbal rating scale) and MVRS (multidimensional verbal rating scale). In dysmenorrhea severity, we standardized scale score and 3-group-severity by score (mild, moderate, severe). For statistics, we used Pearson correlations and Spearman's rho correlations, SPSS 11.0 for windows. Results: In case of MVRS, Chiljehyangbuhwan was correlated to ${\Delta}T$ (CV12 and CV3 / CV12 and CV4). In case of VRS, Chiljehyangbuhwan was not correlated to ${\Delta}T$. Statistically they showed significant result (p<0.05). Conclusion: The primary dysmenorrhea patients showed that severity by MVRS was connected with ${\Delta}T$ (CV12 and CV3 / CV12 and CV4) after Chiljehyangbuhwan administration. So we can consider Chiljehyangbuhwan effects the abdominal temperature according primary dysmenorrhea severity.

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The supplementation effects of peanut sprout on reduction of abdominal fat and health indices in overweight and obese women

  • Ha, Ae Wha;Kim, Woo Kyoung;Kim, Jung Hwan;Kang, Nam E
    • Nutrition Research and Practice
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    • v.9 no.3
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    • pp.249-255
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    • 2015
  • BACKGROUD/OBJECTIVES: This study was conducted in order to investigate the effect of peanut sprout extracts (PSE) on health indices in overweight and obese women (BMI $${\geq_-}23kg/m^2$$). SUBJECTS/METHODS: Subjects were divided into three groups by double-blind randomized trial; the Placebo group (n = 15) and the Low PSE group (2.6 g PSE/day, n = 15), and the High PSE group (5.8 g PSE/day, n = 15). Subjects consumed 12 capsules per day, three times a day, 30 min before meals, for 4 weeks. Anthropometric data, blood biochemical variables, and dietary intake were evaluated before and after the experiments. RESULTS: In the Low and High PSE group, the waist circumference showed a significant decrease between pre- and post-test. In the Low PSE group, the reduction of systolic blood pressure between pre- and post-test was statistically significant. Serum LDL or triglyceride levels in both Low and High PSE groups were significantly decreased, and serum alanine transaminase and aspartate transaminase were significantly decreased only in the Low PSE group. The parameters regarding erythrocyte and leucocyte counts showed no significant differences between pre- and post-test among groups, which suggested the safety of intake of peanut sprouts as a dietary supplement. CONCLUSIONS: This study indicates that PSE supplementation improves abdominal obesity and overall health indices. Therefore, an appropriate amount of peanut sprouts may be a plausible effective agent for obesity and obesity related health problems in obese women.

Evaluation the Effects of Short Term Intake Avena sativa Extracts on Blood Glucose and Cholesterol Level (단기간 귀리 추출물 섭취의 혈당 및 콜레스테롤 저하 효과 평가)

  • Kim, Hana;Lee, Insoo;Shin, Kyungsook;Yoon, Soonkyu;Lee, Buhyung;Yoon, Seungkyu;Choi, Jinwoo;Suh, In Bum
    • The Journal of the Korea Contents Association
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    • v.15 no.3
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    • pp.272-279
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    • 2015
  • Recently, studies about various natural extracts to help control blood glucose has been in progress. Avena sativa is well known to have various physilogical effects. Especially, ${\beta}$-glucan has effect about lowering blood glucose level and prevent cardiovascular dz and adult dz related to obesity. In this study we evaluated the effect of Down and control (BM pharmaceutical) which is consist of commercialized Avena sativa fextracts on blood glucose and cholesterol, 6weeks, randomized, double-blind, placebo-controlled trials. The results show not significantly different in all blood index test group from control group, but in glycated albumin decreased 50.33% for test group, decreased 37.91% for control group, in triglyceride decreased 7.51% for test group, increased 3.98 for control group and we can observed Avena sativa has blood glucose and triglyceride lowering effect in some.

Efficacy of Korean Red Ginseng by Single Nucleotide Polymorphism in Obese Women: Randomized, Double-blind, Placebo-controlled Trial

  • Kwon, Dong-Hyun;Bose, Shambhunath;Song, Mi-Young;Lee, Myeong-Jong;Lim, Chi-Yeon;Kwon, Bum-Sun;Kim, Ho-Jun
    • Journal of Ginseng Research
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    • v.36 no.2
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    • pp.176-189
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    • 2012
  • This study examined the effects of Korean red ginseng (KRG) on obese women and aimed to confirm that the effects of KRG on obesity differ dependently on a gene. Fifty obese women were recruited and randomized to receive KRG (n=24) or placebo (n=26) for 8 wk. Measurements of blood pressure, height, weight, waist circumference, waist-hip ratio (WHR), total fat mass, percentage of body fat, resting metabolic rate, basal body temperature, and daily food intake (FI), blood test (serum lipid, liver and renal function), Korean version of obesity-related quality of life scale (KOQOL), and a gene examination were performed. Comparisons of subjects before and after the administration of KRG revealed significant improvements of obesity in terms of weight, body mass index (BMI), WHR, FI, and KOQOL. However, in the comparison between KRG group and placebo group, only KOQOL was significantly different. KRG displayed significant efficacy on BMI and KOQOL in the CT genotype of the G protein beta 3 gene, but not in the CC genotype, on blood sugar test in the Trp64/Arg genotype of the beta 3 adrenergic receptor gene, but not in Trp64/Trp genotype, on KOQOL in the DD genotype of the angiotensin I converting enzyme gene, but not in the ID and DD genotypes. The effects of KRG on obesity were confirmed to some extent. However, a distinct effect compared to placebo was not confirmed. KRG is more effective for improving the secondary issues of the quality of life derived from obesity rather than having direct effects on the obesity-related anthropometric assessment and blood test indices.

An exploratory study for an evidence of electroencephalographic changes in isolated subjects for distant mental intention

  • Kim, Dae-Keun
    • Science of Emotion and Sensibility
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    • v.17 no.4
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    • pp.51-60
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    • 2014
  • This double-blind study, as a human experiment of nonlocality, investigated the effects of senders' intention on the central nervous system of a distant human receiver and it explored the roles that motivation might have in modulating these effects. Whole brain activity was measured in the receiver whom was asked to relax in a distant room for 16 minutes; the sending person directed intention of oneness toward the receiver during repeated variable-second epochs separated by variable-second non-intention epochs. The total length of intention epochs and that of nonintention epochs were balanced. Eighteen sessions were conducted. In 9 of those sessions, the sender was the receiver's lover. In another 9 of those sessions, the sender was just acquainted with the receiver before the session. The receiver's whole brain activity recorded during the intention epochs were compared with the same measures recorded during the nonintention epochs used as controls. The statistical difference between the intentions versus controls across 18 sessions was examined by paired-t test. In addition, subgroup analysis for the 9 couple sessions and 9 non-couple sessions were additionally examined by the same test. The effect of distant intentionality decreased slow waves or increased EEG fast waves mainly in frontal regions, and increased EEG coherence during the intention epochs. The effects was not statistically significant after Bonferroni correction, but the couple sessions combined showed the largest effect followed by all sessions combined. Non-couple sessions combined showed the smallest effect. The changes in EEG power mean that receiver participants became more alert during the intention epochs and the change in EEG coherence might be evidence of coherent heart influence on EEG activity. Planned comparison with specific hypothesis testing for the suggested changes in this study have to be followed for an evidence of electroencephalographic changes in isolated subjects for the distant mental intention.

Action observation training enhances upper extremity function in subacute stroke survivor with moderate impairment: a double-blind, randomized controlled pilot trial

  • Kim, Chang-Heon;Bang, Dae-Hyouk
    • Journal of the Korean Society of Physical Medicine
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    • v.11 no.1
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    • pp.133-140
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    • 2016
  • PURPOSE: This study's aim was to investigate the effects of an action observational training in subactue stroke patients with moderate impairment. METHODS: 22 participants (men=13, women=9) with hemiparesis were randomly assigned to action observation training group or task-oriented training group. Patients in both group underwent a patient-specific multidisciplinary rehabilitation program. Participants in the action observation group (mean age, $62.78{\pm}9.85$) were asked to watch the video scene, in the knowledge that they would then attempt to perform the same movement task after watching. The control group (mean age, $61.49{\pm}8.64$) practiced the same tasks, without watching the video. To evaluate upper limb function, the upper extremity part of the Fugl-Meyer Assessment upper extremity and the Box and Block Test were used. The modified Barthel index was used to assess ADLs, and the modified Ashworth scale were used to assess spasticity in the upper extremity. RESULTS: The action observational training group exhibited greater changes in the Fugl-Meyer assessment upper extremity (P<0.05; 95% CI, 0.929 - 6.403), the Box and Block test (P<0.05; 95% CI, 0.086 - 5.913), and the modified Barthel index (P<0.01; 95% CI, 2.483 - 12.627) between groups. And the modified Ashworth scale (P>0.05; 95% CI, -0.402 to 0.624) did not show significantly different between groups. CONCLUSION: These findings suggest that action observational training may be more helpful to improve upper-extremity function than physical training only in subactue patients with moderate impairment after stroke.

Behavioral and Physiological Effects Induced by the Acute Administration of Melatonin in Healthy Young Men (정상인에서의 멜라토닌 투여에 따른 행동 및 생리적 효과)

  • Joe, Sook-Haeng;Nam, Min
    • Korean Journal of Psychosomatic Medicine
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    • v.5 no.2
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    • pp.195-204
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    • 1997
  • Objectives : The behavioral and physiological effects following low doses and high doses of melatonin have not been fully explored. In this study the authors investigated the nature and extent of the hypnotic effects, oral temperature, blood pressure effects, performance effects and subjective feelings following the acute administration of low pharmacological oral doses of melatonin at mid-day. Methods : Thirty-five healthy young medical students were randomly assigned to receive 6mg of oral melatonin(N=11), 12mg of oral melatonin(N=12) or a placebo(N=12) in a double-blind, placebo controlled trial. Measures of the behavioral and physiological effects used in the study were Stanford Sleepiness Scale, Digit Symbol Substitution Test, Trail test and visual analogue scale for subjective feelings. Oral temperature and blood pressure were measured. The subjects were studied between 10:00 and 16:00 hours. Data were analyzed by using repeated-measures analyses of variance(ANOVA). Results: Melatonin produced statistically significant effects on oral temperature, but there were no significant effects on time and the $dose{\times}time$ interaction. There was a significant difference on oral temperature between the 12mg oral melatonin group and the placebo group at 12:00 and 16:00 hours, but no significant difference between the 12mg and the 6mg oral melatonin groups. Melatonin produced a dose-related increase in subjective sleepiness and had significant effects on time, the $dose{\times}time$ interaction. There was a significant difference on subjective sleepiness among the placebo, 6mg, 12mg oral melatonin groups at 13:00-16:00 hours. Melatonin did not produce statistically significant dose-related effects on subjective fatigue but produced significant effects on time and the $dose{\times}time$ interaction. There was a significant difference on subjective fatigue between the 12mg, the 6mg oral melatonin groups and the placebo group at 13:00 hour. Conclusions : These data indicated that acute administration of melatonin at mid-day increased subjective sleepiness and fatigue but decreased oral temperatures. These effects were shown especially in 12mg oral melatonin group.

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Articaine (4%) with epinephrine (1:100,000 or 1:200,000) in inferior alveolar nerve block: Effects on the vital signs and onset, and duration of anesthesia

  • Lasemi, Esshagh;Sezavar, Mehdi;Habibi, Leyla;Hemmat, Seyfollah;Sarkarat, Farzin;Nematollahi, Zahra
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.15 no.4
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    • pp.201-205
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    • 2015
  • Background: This prospective, randomized, double-blind, clinical study was conducted to compare the effects of 4% articaine with 1:100,000 epinephrine (A100) and 4% articaine with 1:200,000 epinephrine (A200) on the vital signs and onset and duration of anesthesia in an inferior alveolar nerve block (IANB). Methods: In the first appointment, an IANB was performed by injecting A100 or A200 in 1 side of the mouth (right or left) randomly in patients referred for extraction of both their first mandibular molars. In the second appointment, the protocol was repeated and the other anesthetic solution was injected in the side that had not received the block in the previous session. Systolic and diastolic blood pressures (SBP and DBP) and pulse rate were measured during and 5 min after the injection. The onset and duration of anesthesia were also evaluated. Data were analyzed using t-test and Mann-Whitney U-test, and p-value was set at 0.05. Results: SBP and pulse rate changes were slightly more with A100; however, DBP changes were more with A200, although the differences were not significant (P > 0.05). There were no statistically significant differences in the parameters evaluated in this study. The onset and duration of anesthesia, and the changes in SBP, DBP, and pulse rate during and 5 min after the injection were the same in both the groups. Conclusions: For an IANB, A200 and A100 were equally efficient and successful in producing the block. Epinephrine concentration did not influence the effects of 4% articaine.