• Title/Summary/Keyword: double-blind

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Analysis of Plasma Proteome before and after Oral Administration of Acidic Polysacharide from Panax Ginseng, Double-blind, Placebo-controlled, Randomised Trial (인삼 다당체 경구 투여 전 ${\cdot}$ 후 혈장의 proteome 분석;무작위배정, 이중 맹검, 위약비교시험)

  • Lee, Seon-Goo;Cho, Young-Ho;Kang, Tae-Gyu;Yang, Ha-Young;Yoo, Byong-Chul;Cho, Chong-Kwan;Yoo, Hwa-Seung
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.21 no.5
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    • pp.1185-1193
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    • 2007
  • Ginsing polysaccharide, known to have an immune regulating effect, was administered to 23 randomly selected healthy male subjects with a mean age of 23 years in accordance with an IRB approval. Then, these subjects underwent physico-chemical tests and serum proteome was analyzed from the blood sample taken from these subjects. Analyses of proteome involved image analysis, protein sections and protein identification in sequence after two-dimensional electrophoresis was carried out. During the physico-chemical test, 4 subjects were excluded from the study. In the proteome analysis, identified were 5 spots such as SP40, 40, Cytokeratin 9, hypothetical protein LOC544932, Apolipoprotein E ,similar to Human albumin, which showed differences in the amount of protein expression. In conclusion, changes of 5 proteins were remarkable before and after administration of ginsing polysaccharides. In certain cases, hepatic and renal slight injury occurred. Thus, further clinical study on dosage regimen would be necessary for securing the basis for concentration-dependent effectiveness and safety.

Randomized, Double Blind, Placebo-Controlled Study of Bofu-tsusho-san on Obese Patients (비만환자에 대한 방풍통성산(防風通聖散)의 무작위배정, 이중맹검, 위약-대조군 임상시험)

  • Lee, Ji-Eun;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine for Obesity Research
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    • v.10 no.1
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    • pp.1-16
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    • 2010
  • Objectives The clinical trial was designed to investigate the safety and effects of Bofu-tsusho-san extracts on the change of the weight, body compositions, serum in obese patients. Methods This study was a 4-weeks, double blind, comparative clinical trial. Eligible subjects had a body mass index(BMI) greater than $25\;kg/m^2$ and waist circumference(WC) longer than 85 cm in woman or 90 cm in man. Among 38 subjects, 36 subjects were randomized either to Bofu-tsusho-san or placebo. After 4 weeks of treatment, we measured anthropometric factors(weight, height, WC, BMI etc.), abdominal fat area by CT scanning, serum lipid(total cholesterol(TC), triglyceride(TG), HDL cholesterol, LDL cholesterol), blood level of variety(glucose, adiponectine, leptin, C-reactive protein(CRP) etc.), blood pressure(BP). Adverse events also evaluated. Results BMI, BP, TG, CRP were reduced and weight, WC, score of KOQOL(Korean version of obesity-related QOL scale), SRI(Stress response inventory) were significant changed in Bofu-tsusho-san. But there were no considerable difference between Bofu-tsusho-san and placebo. there were no serious adverse events in either group. Conclusion There were limitations in this study that it conducted within a short period of 4 weeks. but its weight and WC loss effect was significant and it had few adverse events.

A Double-blind Comparison of 0.125% Ropivacaine with Fentanyl and 0.125% Bupivacine with Fentanyl for Labor Analgesia Using Patient-Controlled Epidural Infusion (지속적 통증조절기를 이용한 경막외강으로 Fentanyl을 첨가한 0.125% Ropivacaine과 0.125% Bupivacaine 주입시 분만통 조절에 대한 효과)

  • Choi, Jeong-Hwan;Lee, Hae-Jin;Sung, Choon-Ho
    • The Korean Journal of Pain
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    • v.13 no.1
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    • pp.67-73
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    • 2000
  • Background: This study intends to evaluate the benefits of the administation of continuous infusion and demand doses of 0.125% ropivacaine compared with 0.125% bupivacaine after addition of fentanyl using patient controlled epidural analgesia (PCEA) for pain control during labor. Methods: Thirty-nine American Society of Anesthesiologists physical status 1 or 2 parturients were randomized by double blind design to receive either 0.125% bupivacaine with fentanyl 1 ug/ml or equivalent concentration of ropivacaine/fentanyl using PCEA; with 6~8 ml/hr basal rate, 3 ml bolus, 5 min lockout, 30 ml/hr dose limit. We assessed analgesia, the amount of study solution used in PCEA, sensory levels, motor block (0~3 scales), side effects and patient satisfaction. A postpartum questionnaire was carried out afterward. Results: There were no differences in visual analogue scores (VAS) for pain, hourly study solution use, sensory levels, side effects and patient satisfaction between groups. However, patients administered ropivacaine/fentanyl had significantly less demand, less administered in PCEA, less numbness and restriction of movement compared with patients in the bupivacaine/fentanyl group. Conclusions: Ropivacaine 0.125% with fentanyl, when administerd epidurally by PCEA for labor analgesia, was equally efficious as bupivaciane 0.125% with fentanyl, having with minimal numbness and restriction of motion.

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Randomized, Double-Blind Study of Efficacy and Safety of Gynostemma pentaphyllum Ethanol Extract in a Normal Population (정상인에서 스트레스와 불안에 대한 돌외추출물의 효과와 안전성에 관한 무작위 배정 이중 맹검 임상시험)

  • Jeong, Seong-Hae;Lee, Myung-Koo;Park, Mi-Sook;Kim, Jae-Moon
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.2
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    • pp.131-137
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    • 2011
  • The purpose of this study was to evaluate the clinical efficacy of a standardized special ethanol extract from Gynostemma pentaphyllum as a management for anxiety and stress of normal population. This is a two-arm, parallelgroup, randomized, double blind clinical trial comparing Gynostemma pentaphyllum extract 200 mg bid (GP-EX, n=48) or placebo bid (n=54). The main outcome measures were the decrease in anxiety sensitivity index (ASI), the State version (S-STAI) of the Stait-Trait Anxiety Inventory (STAI) and the Trait version (T-STAT) of the STAI from baseline over a 6 weeks treatment period. In more anxious group (S-STAI50 or ASI19), the anxiety in group with GP-EX was decreased significantly than one in normal population with placebo [S-STAI50: T-STAI = from $57.7{\pm}6.5$ ($mean{\pm}S.D.$) to $46.8{\pm}11.2$ in normal population with GP-EX, p=0.002 vs. from $54.1{\pm}9.9$ to $49.0{\pm}9.6$ in normal population with placebo, p>0.05; ASI19: T-STAI = from $47.2{\pm}12.0$ to $42.4{\pm}11.1$ in normal population with GP-EX, p=0.022 vs. from $48.7{\pm}11.5$ to $46.0{\pm}10.4$ in normal population with placebo, p>0.05]. The most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events. GP-EX is more effective than placebo and is well tolerated as a therapy for anxiety and stress of normal population.

Onion peel extract reduces the percentage of body fat in overweight and obese subjects: a 12-week, randomized, double-blind, placebo-controlled study

  • Lee, Ji-Sook;Cha, Yong-Jun;Lee, Kyung-Hea;Yim, Jung-Eun
    • Nutrition Research and Practice
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    • v.10 no.2
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    • pp.175-181
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    • 2016
  • BACKGROUND/OBJECTIVES: The anti-obesity effect of quercetin-rich onion peel extract (OPE) was suggested in rats, but information from human studies is limited. This study aimed to investigate the effects of OPE on the body composition of overweight and obese subjects. MATERIALS/METHODS: In this 12-week, randomized, double-blind, placebo-controlled study, parallel clinical trials were performed in overweight and obese Korean subjects. Randomly assigned subjects were instructed to take daily either the placebo (male, 6 and female, 30) or OPE capsules containing 100 mg of quercetin (male, 5 and female, 31). Body composition was measured by using bioimpedance and dual-energy X-ray absorptiometry (DXA). Resting energy expenditure (REE) and respiratory quotient (RQ) were evaluated by using indirect calorie measurement methods. Fasting blood levels of glucose, insulin, lipids, and leptin were determined. RESULTS: Quercetin-rich OPE supplementation significantly reduced the weight and percentage of body fat as measured by DXA (P = 0.02). These effects were not shown in the control group. Levels of blood glucose (P = 0.04) and leptin (P = 0.001 for placebo, P = 0.002 for OPE) decreased in both groups. Significant increases in REE and RQ were observed in both groups (P = 0.003 for placebo, P = 0.006 for OPE) and in the OPE group alone (P = 0.02), respectively. CONCLUSIONS: Quercetin-rich OPE supplementation changed the body composition of the overweight and obese subjects. This result suggests a beneficial role of the anti-obesity effect of OPE human subjects.

A Double-Blind, Sham-Controlled, Pilot Study to Assess the Effects of the Concomitant Use of Transcranial Direct Current Stimulation with the Computer Assisted Cognitive Rehabilitation to the Prefrontal Cortex on Cognitive Functions in Patients with Stroke

  • Park, See-Hyun;Koh, Eun-Jeong;Choi, Ha-Young;Ko, Myoung-Hwan
    • Journal of Korean Neurosurgical Society
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    • v.54 no.6
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    • pp.484-488
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    • 2013
  • Objective : To examine the synergistic effects of both computer-assisted cognitive rehabilitation (CACR) and transcranial direct current stimulation (tDCS) on cognitive function in patients with stroke. Methods : The current double-blind, sham-controlled study enrolled a total of 11 patients who were newly diagnosed with stroke. The patients of the tDCS group (n=6) completed sessions of the Korean computer-assisted cognitive rehabilitation program five times a week for 30 minutes a session during a mean period of 18.5 days concomitantly with the anodal tDCS over the bilateral prefrontal cortex combined with the CACR. The patients of the control group (n=5) also completed sessions of the sham stimulation during a mean period of 17.8 days. Anodal tDCS over bilateral prefrontal cortex (F3 and F4 in 10-20 EEG system) was delivered for 30 minutes at an intensity of 2 mA. Cathode electrodes were applied to the non-dominant arm. All the patients were evaluated using the Seoul Computerized Neuropsychological Test (SCNT) and the Korean Mini-Mental State Examination. Results : Mann-Whitney U test revealed a significant difference between the two groups. The patients of the tDCS group achieved a significant improvement in the post/pre ratio of auditory continuous performance test and visual continuous performance test on the SCNT items. Conclusion : Our results indicate that the concomitant use of the tDCS with CACR to the prefrontal cortex may provide additional beneficial effects in improving the cognitive dysfunction for patients with stroke.

Double-blind Randomized Controlled Trials on Blood Pressure and Pulse Rate of Korean Ginseng and American Ginseng in Koreans and Chineses (한국인과 중국인에서 고려삼과 화기삼의 혈압과 맥박에 대한 이중맹검-무작위배정 임상시험)

  • Seo Jung Chul;Lee Se Yun;Lee Kyung min;Leem Sung Chul;Jeong Tae Young;An Hee Duk;Han Sang Won;Ha Il Do;Heo Zheng Jie;Lee Kyung lim;Kim Myung soo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.18 no.2
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    • pp.606-611
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    • 2004
  • In East-South Asia it has been known that Korean ginseng(Panax ginseng) increases blood pressure, whereas American ginseng(Panax quinquefolius) doesn't. This study was designed to find out if Korean ginseng really could increase blood pressure comparing with American ginseng. Double-blind randomized controlled trials on blood pressure and pulse rate of Korean ginseng and American ginseng in Koreans and Chineses was performed. There was no significant difference on blood pressure and pulse rate between Korean ginseng and American ginseng in both Koreans and Chineses by repeated-measures ANOVA. It was revealed that Korean ginseng does not increase blood pressure. Maybe the concept that Korean ginseng increases blood pressure is concerned with commercial interests dealing with American Ginseng.

Clinical Studies of Sweet Bee Venom to the Effect of Abdominal Fat Accumulation (Sweet BV의 침감비교 연구)

  • Lim, Chung-San;Park, Won-Pil;Jang, Seong-Bong;Choi, Young-Chon;Park, Do-Il;Kwon, Ki-Rok;Lee, Hee-Choon
    • Journal of Pharmacopuncture
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    • v.11 no.2
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    • pp.55-62
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    • 2008
  • Objective Sweet bee venom is made by removing allergen from the bee venom through gel filtration chromatography and propionic acid/urea polyacrylamide gel electrophoresis. The aim of this study was to verify allergy inhibitory action in Sweet Bee Venom(SBV) and New Sweet Bee Venom(NSBV) removed enzymes and compounds of low molecular weight. Methods 84 healthy adult men and women were selected through a survey whom had never received the bee venom therapy in the past. The concentration of Normal Saline, SBV and NSBV pharmacopuncture was equally at 0.1mg/mL and the experiment was conducted as the double blind test. Results Participants of the study was comprised of 63 men and 21 women with the average age of 28.3 years. According to results of pain sense, SBV group showed significant higher score compared with NS group and NSBV group using VAS in treating time. And SBV and NSBV group showed significant higher score compared with NS group after 30 minutes. Other allergic responses were insignificant between the groups. Conclusions As a result of removed allergen and compounds of low molecular weight, NSBV significantly inhibits pain sense in treating time compared with SBV. This indicates wider and easier application of NSBV for the useful application in clinical treatment. Further comparative studies should be conducted to yield more objective verification.

Evaluations on Salivary Flow Induction and Dissolution Patterns in Saliva of Pilocarpine Chewing Tablet in Healthy Human Volunteers (건강한 성인 지원자를 대상으로 한 필로칼핀 저작정의 타액분비 유도 및 타액중 용출패턴 평가)

  • Park, Kyoung-Ho
    • Journal of Pharmaceutical Investigation
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    • v.27 no.4
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    • pp.331-335
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    • 1997
  • Xerostomia is caused by organic or functional changes affecting the salivary system at different levels. Patients suffering from xerostomia may also complain of an oral burning sensation, ulceration or soreness, difficulty in swallowing, and poor denture retention. And pilocarpine is administered orally to induce salivary secretion. In Seoul National University Hospital(SNUH) pharmacy, the pilocarpine chewing tablets are prepared and supplied to patients of xerostomia in request of the dental hospital in SNUH. And we tested the salivary flow induction and the dissolution patterns of these products in saliva by a double-blind, sequential cross-over trials to eight healthy human volunteers with placebo. The pilocarpine chewing tablet contained 5 mg of pilocarpine, and placebo consisted of same materials as test drug, but didn't contain pilocarpine. In vivo experiment, all subjects were instructed to chew as 60-80 times/min. Mixed saliva was collected in the ranges of intervals such as 0-2, 2-5, 5-10, 10-15, 15-20, 20-30, 30-45 and 45-60 min after pilocarpine chewing tablet or placebo administration. Saliva volume was measured in each collecting time interval, and saliva pilocarpine concentrations were determined by reversed phase HPLC. The 82.5 percent $(4.13{\pm}0.69\;mg)$ of pilocarpine was extracted from chewing tablets during mastication of 60-80 times per minute for 60 minutes. Among these dissolved amounts, 90 percent was extracted within 20 minutes. The salivary flow rates were more increased in a group who administered pilocarpine chewing tablet at the interval of 5-10, 10-15, 20-30 and 45-60 min rather than a placebo-group, but only extracted amount of pilocarpine at 45-60 min interval is significanly different between two groups (p<0.05). But total amounts of saliva secreted for 1 hour in two group-pilocarpine and placebo treated- were $46.36{\pm}9.72\;ml\;and\;39.09{\pm}7.81\;ml$, respectively, and were not significantly different between two groups.

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Effects of phylloquinone supplementation on lipid profile in women with rheumatoid arthritis: a double blind placebo controlled study

  • Kolahi, Sousan;Gargari, Bahram Pourghassem;Abbasi, Mehran Mesgari;Jafarabadi, Mohammad Asghari;Shishavan, Neda Ghamarzad
    • Nutrition Research and Practice
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    • v.9 no.2
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    • pp.186-191
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    • 2015
  • BACKGROUND/OBJECTIVES: Rheumatoid arthritis (RA) is associated with an excess mortality from cardiovascular disease which is likely attributed to an atherogenic lipid profile. Among nutritional factors vitamin K has been recently focused as a pivotal nutrient in improvement of lipid related markers. Thus, this study was designed to determine the effects of vitamin K on lipid profile in this disease. SUBJECTS/METHODS: Fifty eight patients with definitive RA were participated in the present double blind placebo controlled study. They were randomly allocated into two groups to receive vitamin $K_1$ as phylloquinone [10 mg/day] (n = 30) or placebo pills (n = 28), for eight weeks. In order to control the effects of probable confounders dietary intakes, anthropometric measurements including weight and height, clinical status using disease activity score-28 (DAS-28), physical activity and anxiety status were evaluated at baseline. Moreover, serum levels of lipid related markers including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) were measured at baseline and at the end of intervention. RESULTS: There were no significant differences between the two groups regarding any of the baseline characteristics. After adjusting for some relevant confounders, in comparison between two groups, we observed no significant changes in lipid related markers at the end of intervention. Also, there was no significant difference between before and after intervention values within groups (P > 0.05). CONCLUSIONS: Function of vitamin $K_1$ in lipid profile modification remains still controversial. This study showed that vitamin $K_1$ has no effect on lipid profile in women with rheumatoid arthritis. Further studies with a longer follow-up are required to determine the effects of vitamin K on atherogenic lipid profile.