• Title/Summary/Keyword: 위약효과

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Efficacy and Adverse Events of Bangpungtongseong-san(Bofutsusho-san) and Bangkihwangki-tang(Boiogiot-tang) by Oriental Obesity Pattern Identification on Obese Subjects : Randomized, Double Blind, Placebo-controlled Trial (비만 환자에서 한방 비만 변증에 따른 방풍통성산과 방기황기탕의 치료효과 및 부작용 비교 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Lee, Myeong-Jong;Kim, Ho-Jun;Hong, Sun-woo;Lee, Dong-Ki;Yoo, Jae-Wook;Choi, Sun-Mi;Moon, Jin-Seok;Lim, Chi-Yeon;Lee, Jung-bok
    • Journal of Korean Medicine Rehabilitation
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    • v.21 no.2
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    • pp.265-278
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    • 2011
  • Objectives : This trial were conducted to evaluate the efficacy and adverse events of Bofutsusho-san(BTS) and Boiogiot-tang(BOT) by oriental obesity pattern identification on obese subjects, as compared to placebo. Methods : 166 subjects(body mass index ${\geq}25kg/m^2$) were recruited and randomized to receive BT(n=55), FH(n=55) or placebo(n=56) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure(BP), pulse rate, resting metabolic rate and oriental obesity pattern identification questionnaire were measured at baseline and 8 weeks. Adverse events and safety outcome variables were also checked during trials. Results : The frequency of top-scored oriental obesity pattern was ordered by indigestion(食積) > stagnation of the liver qi(肝鬱) > yang deficiency(陽虛) > spleen deficiency(脾虛) > phlegm(痰飮) > blood stasis(瘀血) in subjects. BTS group significantly decreased body weight, body mass index(BMI), waist circumference(WC), body fat mass, total cholesterol and HDL-cholesterol in stagnation of the liver qi(肝鬱) and WC in indigestion(食積). BOT group showed significant decrease of body weight, BMI, WC, and body fat mass in indigestion(食積) not in deficiency(虛症). Adverse events were reported most frequently in yang deficiency(陽虛) by BT group and stagnation of the liver qi(肝鬱) by BOT group. Conclusions : Bofu-tsusho-san was effective in treating obesity with stagnation of the liver qi(肝鬱). Obesity pattern identification could be a useful diagnostic tool predicting treatment effects and adverse events.

Effect of Korean Red Ginseng Extract on Blood Circulation in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial (건강한 지원자에서 홍삼농축액의 혈행 개선 효과: 무작위, 이중맹검, 위약-대조 시험)

  • Shin, Kyeong-Seob;Lee, Jung-Jin;Kim, Yeong-Il;Yu, Ji-Yeon;Park, Eun-Seok;Im, Ji-Hyun;You, Soon-Hyang;Oh, Ki-Wan;Lee, Myung-Koo;Wee, Jae-Joon;Kim, Young-Sook;Yun, Yeo-Pyo
    • Journal of Ginseng Research
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    • v.31 no.2
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    • pp.109-116
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    • 2007
  • Korean red ginseng has broad efficacious effects against hypertension, diabetes, nociception, and cancer, and it counteracts weakness. It has been reported that Korean red ginseng is able to normalize blood pressure, improve cholesterol and lower blood glucose levels. We have recently reported that Korean red ginseng extract (KRGE) significantly prevented rat carotid arterial thrombosis in vivo, and inhibited platelet aggregation ex vivo and in vitro in a dose-dependent manner. The purpose of this study was to examine the effects of KRGE on blood circulation in human by measuring ex vivo platelet aggregation, plasma coagulation and serum lipid profiles in healthy volunteers. Subjects were randomly divided into three groups (placebo-group, KRGE-low dose group, KRGE-high dose group). Administration of KRGE to subjects significantly inhibited ADP-induced platelet aggregations both in KRGE-low dose group from $72.79{\pm}20.53$ to $62.00{\pm}23.06%$ (p=0.0009), and in KRGE-high dose group from $75.14{\pm}21.86$ to $64.52{\pm}24.72%$ (p=0.0039), respectively. Administration of KRGE to subjects also significantly inhibited collagen-induced platelet aggregations both in KRGE-low dose group from $85.52{\pm}12.57$ to $79.62{\pm}20.47%$ (p=0.0916), and in KRGE-high dose group from $80.24{\pm}18.11$ to $70.31{\pm}25.93%$ (p=0.0565), respectively. Whereas, KRGE has no significant effects on coagulation system, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), and serum lipid profiles, such as total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride. KRGE also has no significant effects on hematological and serum biochemical profiles. These results suggest that KRGE has a potential to improve blood circulation through antiplatelet activity in human, and KRGE intake may be beneficial for the individuals with high risks of thrombotic and cardiovascular diseases.

Hypoglycemic Effect of Naturaceuticals Extract Supplementations in NIDDM Patients (천연소재 혼합물 섭취가 당뇨환자의 혈당 및 당화혈색소에 미치는 영향)

  • Kim, Hyun-Sook;Kim, Dae-Jung;Hwang, Ha-Jin;Lee, Hyun-Joo;Choe, Myeon
    • Applied Biological Chemistry
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    • v.50 no.1
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    • pp.68-71
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    • 2007
  • Cordyceps militaris, Artemisa capillaris, and Fagopyrum esculentum have been known to maintain normal blood sugar levels in folk medicine. We investigated the effects of these nutraceuticals extract supplementations on fasting and postprandial blood glucose in diabetes mellitus patients. The study population consisted of 50 diabetes subjects with a mean fasting blood glucose of 186.8${\pm}$6.2 mg/dl and postprandial blood glucose of 292.8${\pm}$10.3 mg/dl. They consumed 3 tea bags (3g per meal) of the extract of selected plants for 17 weeks. Patients treated with nutraceuticals extract supplementation showed a significant decrease of fasting blood glucose (118.4${\pm}$3.9 mg/dl) and postprandial blood glucose (160.5${\pm}$4.0 mg/dl) in 7 weeks. Nutraceticals extract supplemantation caused a significant decrease of 36.5% and 45% in fasting and postprandial blood glucose levels, respectively, and also significantly decreased HbA1c levels. This study shows that extract of nutraceuticals supplementation significantly lowered the fasting and postprandial blood glucose levels in NIDDM patients. These effects presumably contribute to the hypoglycemic activity.

Effects of Unripe Rubus Coreanus Extract on Upper Body Obesity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (미숙과 복분자 추출물의 상체비만 개선 효과: 무작위배정, 이중눈가림, 위약-대조 임상연구)

  • Ha, Ki Chan;Kim, Hye Mi;Baek, Hyang Im;Jeong, Da Young;Kim, Eun;Lee, Ki Hoon;Kim, Ha Rim;Kwon, Kang Beom;Kim, Sunoh;Lee, Jung Han
    • 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.

Role of the Baseline Heart Rate Variability to the Effect of the Huanglian-Jie-Du Granule in Hwa-Byung Patients: Supplementary Analysis from the Randomized Trial Comparing Huanglian-Jie-Du Granule and Placebo for Hwa-Byung (화병 환자의 심박변이도 차이에 따른 황련해독탕의 효과: 화병에 대한 무작위 대조 비교임상시험 결과의 추가 분석)

  • Choi, Yu-Jin;Cho, Seung-Hun
    • Stress
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    • v.26 no.4
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    • pp.305-311
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    • 2018
  • Background: The purpose of the study was to explore whether the effect of Huanglian-jie-du granule depends on the baseline heart rate variability in patients with Hwa-byung. Methods: We used the supplementary data from a randomized, double-blind, placebo-controlled trial of Huanglian-jie-du granule for Hwa-byung patients. Study drugs were taken orally three times per day for one week. Heart rate variability was measured three times; before the treatment, after the treatment, and month follow-up period. Spearman's rho test was done to explore the role of the baseline heart rate variability to the effect of Huanglian-jie-du granule. Results: Baseline low frequency power of heart rate variability was negatively correlated with the reduction of the insomnia severity index in experimental group (r=-0.493 p=0.02). Also, Huanglian-jie-de granule significantly decreased the low frequency power of heart rate variability in patients with Hwa-byung compared to placebo (mean difference 266 [95% CI: 29~503], p=0.028). In Hwa-byung symptoms, stuffy, pushing up in the chest, and flush of anger were correlated with low frequency power of heart rate variability (p=0.010, p=0.000, and p=0.016, respectively). Conclusions: The effect of the Huanglian-jie-de granule for insomnia seems to be lower when the baseline low frequency power of heart rate variability is higher in Hwa-byung patients. Also, Huanglian-jie-de granule is likely to decrease the sympathetic activity in patients with Hwa-byung. Measurement of heart rate variability may be the useful to understand the state of Hwa-byung patients.

Positive effect of Saengmaeg-san intake on blood lipid and arteriosclerosis index during high-intensity training (고강도 트레이닝 시 생맥산 섭취가 혈중 지질 및 동맥경화 지수에 미치는 긍정적인 영향)

  • Kwak, Jae-Jun;Lee, Jae-Hoon;Yook, Jang Soo;Lee, Sang-Ho;Ha, Min-Seong
    • Journal of the Korean Applied Science and Technology
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    • v.38 no.6
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    • pp.1512-1523
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    • 2021
  • The purpose of this study was to investigate the effect of Saengmaeg-san intake on blood lipids and arteriosclerosis index in male tennis players. Seventeen male tennis players enrolled in university were assigned to a Saengmaeg-san intake group (n=9) and a placebo control group (n=8) according to whether they took Saengmaeg-san during 4-week high-intensity tennis training. Tennis training was conducted 5 times a week for 4 weeks, and the exercise intensity was performed at 70-90% of the spare heart rate. The intake of Saengmaeg-san was 110ml at a time before breakfast, before, during, during, and after exercise, and after dinner, a total of 7 times, 770ml per day. For all data, mean and standard deviation were used. Two-way repeated measures ANOVA was used to examine the effect of time and treatment, and Pearson's Correlation was used to examine the relevance of differences in blood lipid responses after treatment. As a result of this study, the Saengmaeg-san intake group significantly improved blood lipids (triglyceride, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) and arteriosclerosis index, and there was a significant correlation appeared between ∆TG, ∆LDL-C, and ∆TC. As a result, the intake of Saengmaeg-san during high-intensity training of male college student tennis players can have a positive effect on blood lipids and arteriosclerosis index, suggesting that it can be an effective sports drink as an exercise supplement.

Effects on the Respiratory Function, Lower Extremity Muscle Activity and Balance for the Wellness of Stroke Patients - Focused on Whole Body Vibration Exercise Combined with Breathing Exercise - (뇌졸중 환자의 웰니스를 위한 호흡기능, 하지근활성도 및 균형에 미치는 효과 - 호흡운동을 결합한 전신진동운동을 중심으로 -)

  • Kang, Jeong-Il;Yang, Sang-Hoon;Jeong, Dae-Keun
    • Journal of Korea Entertainment Industry Association
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    • v.14 no.8
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    • pp.397-405
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    • 2020
  • The purpose of study was to compare respiratory function and quadriceps muscle activity in stroke patients by applying inspiratory muscle training combined with whole body vibration. In addition, the purpose of study is to present an exercise method for improving the respiratory function of stroke patients and the function of the lower limb muscles of stroke patients. Totally, 21 patients with Stroke patients were randomly assigned to two groups through clinical sampling. 11 patients who applied whole body vibration combined with respiratory exercise were randomly assigned to Experiment Group I, and 10 patients who applied placebo exercise combined with breathing exercise were randomly assigned to Experiment Group II. And for 5 weeks, 4 days/week, 1 time/day, 4 sets/1 time intervention program was implemented. Before intervention, the respiratory function was measured with a maximum inspiratory pressure meter, the lower extremity muscle activity was measured using the surface EMG, and the balance ability was measured using a bug balance test. And after 5 weeks, the post-test was re-measured and analyzed in the same way as the pre-test. In the comparison of changes within the group of experimental group I, there were significant differences in the activity and balance of the respiratory muscle strength, the biceps femoris, and the anterior tibialis muscle (p<.05). In the comparison of the changes in the experimental group I, there was a significant difference in respiratory strength and balance (p<.05). In the comparison of changes between groups, there was a significant difference in the activity of the biceps femoris and anterior tibialis (p<.01). In the future, research on protocols for respiratory exercise and whole body vibration to improve neuromuscular function is considered to be necessary.

Effect of Glucose Control, SDSCA and Quality of Life of D-chiro-inositol(DCI) in patients with type 2 diabetes: A Path Analysis (제2형 당뇨병 환자의 D-chiro-inositol의 혈당강하 효과와 당뇨 자가관리 및 삶의 질: 경로분석)

  • Kang, Young Mi;Kim, Hyun Jin;Lee, Tae-Yong;Ku, Bon-Jeong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.10
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    • pp.243-253
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    • 2018
  • This study aimed to investigate the effects of DCI on glucose control, quality of life(SF-36 Version 2.0, Korean) and SDSCA(Summary of Diabetes Self-Care Activities) in patients with type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled study was performed on 46 patients with HbA1c 7.0% taking triple anti-diabetic drug regimen who visited the department of Endocrinology and Metabolism in Chungnam National University Hospital between March 2015 and May 2016. As a result, DCI treatment in the intervention group resulted in significantly reduced HbA1c levels $8.75{\pm}0.79%$(baseline), $8.36{\pm}1.03%$(after 12weeks), and $8.65{\pm}0.81%$(after 24weeks). However, patients in the control group did not show any significant change. Interestingly, both DCI treatment group and the control group significantly showed improvements in SDSCA. Participants in the intervention group showed a small yet significant improvement in their only fasting blood glucose test in SDSCA and revealed significant increase in the quantitative levels of quality of life, from $73.05{\pm}16.85$ to $82.74{\pm}10.68$. By using pathway analysis, improvement of SDSCA scores(${\beta}=-0.505$, t=-2.743) was the most influential factor to the fasting blood glucose. The quality of life of patients with type 2 diabetes mellitus was affected by changes of SDSCA scores(${\beta}=0.411$, t=2.024) and fasting c-peptide(${\beta}=-0.445$, t=-2.668) in DCI treatment group. In conclusion, treatment of DCI effectively improved glucose control in patients with type 2 DM(HbA1c level>7.0%) after 12 weeks of treatment, although it had no impact on glucose control after 24 weeks of treatment. Improved glucose control may encourage diabetic patients to conduct self-care activities and improve the quality of life. Based on the present study, we suggest that diabetes self-management, as well as consideration of comprehensive laboratory findings, may be important factor in regulating the quality of life in type 2 DM patients.

The Effect of Green Coffee Bean Extract Supplementation on Body Fat Reduction in Overweight/Obese Women (과체중 여성에서 생커피두 엑기스의 섭취가 체지방 개선에 미치는 영향)

  • Park, Ju-Yeon;Kim, Ji-Young;Lee, Sung-Pyo;Lee, Jong-Ho
    • Journal of Nutrition and Health
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    • v.43 no.4
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    • pp.374-381
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    • 2010
  • This study was performed to examine the diet effect of green coffee bean extract on body fat reduction. Overweight/obese women (body mass index > $23\;kg/m^2$ or body fat > 27%) who were not diagnosed any type of disease were included in this study and subjects were randomly assigned to green coffee bean extract group (n = 23) or placebo group (n = 20). We measured anthropometric parameters, abdominal fat distribution by computed tomography and blood components before and after the 8-weeks intervention period. After supplementation, green coffee bean extract group showed a significant reduction of body weight (p < 0.01), body fat percent (p < 0.01), total fat area at L1 vertebra (-4.8%, p < 0.05) and visceral fat area at L4 vertebra was(-4.7%, p < 0.05). In addition, total fat area and visceral fat area at L1 vertebra decreased significantly in green coffee bean extract group compared with placebo group (p < 0.05, p < 0.05 respectively). The result of present study demonstrated that the supplementation of green coffee bean extract for 8 weeks can give beneficial effects on body fat reduction and visceral fat accumulation.

The Effects of Mixtures with Ginseng Radix rubra and Paeonia Radix on Endurance Exercise Performance (홍삼과 백작약의 혼합물 투여가 지구성 운동수행능력에 미치는 영향)

  • Kim, Seung-Kyum;Kim, Chang-Ju;Kim, Hong;Lim, Yong-Taek;Yoon, Sung-Jin
    • Journal of Ginseng Research
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    • v.31 no.2
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    • pp.93-101
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    • 2007
  • The purpose of this study is to examine the improvement of endurance exercise performance by taking mixtures of Ginseng Radix rubra and Paeonia Radix. For this purpose, time of exhaustion, $V0_2max$, heart rate, and blood lactate was used as improvement index. The experiments were executed to thirty eight men in their twenties. They were randomly assigned into four groups[CG: control group(n=10), IG: ingestion mixtures group(n=9), TPG: ingestion placebo+training group(n=9), TIG: ingestion mixtures+training group(n=10)]. IG and TIG took mixtures of Ginseng Radix rubra and Paeonia Radix for four weeks, and TPG and TIG exercised once a day, three times a week, exercised for 25 minutes during the first week and added 2 minutes by week during four weeks up to 75% of their maximum heart rate. Time of exhaustion showed statistically significant increase for IG, TPG and TIG. TIG had the longest time of exhaustion and IG the shortest. In case of $VO_2max$, no statistically significant change was found among four groups. However, IG, TPG, TIG showed small increase in $VO_2max$. Similarly, no significant change was found for heart rate in rest even though TIG and TPG appear to have decreasing trend. For maximum heart rate, no significant change was found either, but IG, TPG and TIG showed increase. In case of blood lactate from rest to exercise until 18 minutes, no group had significant decrease. In case of blood lactate in exhaustion, IG, TPG and TIG had significant increase. Blood lactate recovery volume at 5 minutes, 10 minutes, 20 minutes showed no significant results for all four groups, but TIG and TPG had a small increase.