• Title/Summary/Keyword: human clinical trial

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A review study of treatment effects for vascular dementia (혈관성 치매 치료 약물에 대한 문헌 고찰 연구 : 외국문헌을 중심으로)

  • Lee, Young-Joon;Han, Chang-Hyun;Jeon, Won-Kyung;Baek, Kyung-Min;Cheon, Woo-Hyun;Choi, Seong-Hun
    • Journal of Society of Preventive Korean Medicine
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    • v.15 no.2
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    • pp.51-67
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    • 2011
  • The average human life span has increased due to the development of modern medicine and science, resulting in prolonged life expectancy and increase in the population counts of the geriatric age group. In particular, a dramatic increase of elderly patients suffering from senile disorders including neurodegenerative diseases, Alzheimer's disease(AD), and vascular dementia has become a serious social problem in public health. Thus, this study is aimed to summarize available clinical trial data on several commonly used medicines include donepezil, rivastigmine, galantamine, memantine and oriental medicine, and examine the effect of oriental medicine combined with western medicine in the treatment of patients with senile disorders using the data from literature reviews and survey studies.

The analysis of Research about Adiponectin (아디포넥틴(adiponectin) 관련 연구논문 분석)

  • Byeon, Young-Soon
    • Journal of Korean Biological Nursing Science
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    • v.12 no.3
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    • pp.175-185
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    • 2010
  • Purpose: The purpose of this study is to analyze the trend of research on intervention using adiponectin and to find the utilization in nursing. Methods: A systematic literature review was conducted. From 2005 to 2009, the articles were searched electronically using the data base with the key words of adiponectin. The criteria for inclusion in review were 1) an randomized clinical trial (RCT), 2) human, 3) English or Korean language. Finally, 89 articles (41 domestic studies, 48 foreign studies) were included in the review. Results: The major findings of this study were as follows: 1) In domestic studies, subjects of obesity were 80.5%, and the most frequently used intervention were exercise (95.1%). 2) In foreign studies, there were interventions for subjects of obesity (55.1%), and diabetes (25.0%). 66.7% of studies were in medicine including 56.3% on medicine/hormone therapy. 3) Adiponectin was significantly increased in 31 domestic studies and 33 foreign studies. Conclusion: It needs to understand the influence of Adiponectin in nursing research and practice. The practical use of Adiponectin has to be considered in a sense that it may help determining the direction of the nursing research to provide more objective evidence for nursing practice.

The Effect of Arm Movements in the during Standing Position on Lower Limb Global Synkinesis and Balance in Stroke Patients

  • Moon, YoungJun;Jeong, DaeKeun;Kang, Jeongil
    • Journal of International Academy of Physical Therapy Research
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    • v.10 no.3
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    • pp.1849-1855
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    • 2019
  • Background: Stroke patients require arm movement exercising for various stimulations in standing position for various stimulations rather than in a sitting position because they require integrated skillful movements, such as stretching, holding, and controlling. Objective: This study was conducted to provide foundational clinical data about lower limb global synkinesis in stroke patients using arm movements in a standing position. Design: Randomized controlled trial. Methods: The subjects were divided into a control group (n = 10) and an experimental group (n = 10), and a pre-test was conducted to evaluate leg global synkinesis (GS) and balance. Intervention method is stretching an arm to hold a ball, repeating supination and pronation of the hand only while maintaining the arm extended as much as possible, repeating shoulder abduction and adduction while holding the pegboard. This was followed by a three-week intervention during which re-measurement was conducted in the same way as was done for the pre-test. Results: The control group showed a significant difference in GS and balance during plantar flexion (p<.05), and the experimental group showed a significant difference in GS and balance during all movements (p<.05, p<.01, respectively). There was a significant difference in GS and balance between the two groups during dorsiflexion (p<.05, p<.01, respectively). Conclusion: The findings demonstrate that human arm movements in a standing position can reduce GS in the affected limb, and balance can be improved by stimulating the surrounding tissues of the affected limb and changing them positively.

Surfactant preparations for preterm infants with respiratory distress syndrome: past, present, and future

  • Jeon, Ga Won
    • Clinical and Experimental Pediatrics
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    • v.62 no.5
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    • pp.155-161
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    • 2019
  • Following the first successful trial of surfactant replacement therapy for preterm infants with respiratory distress syndrome (RDS) by Fujiwara in 1980, several animal-derived natural surfactants and synthetic surfactants have been developed. Synthetic surfactants were designed to overcome limitations of natural surfactants such as cost, immune reactions, and infections elicited by animal proteins contained in natural surfactants. However, first-generation synthetic surfactants that are protein-free have failed to prove their superiority over natural surfactants because they lack surfactant protein (SP). Lucinactant, a second-generation synthetic surfactant containing the SP-B analog, was better or at least as effective as the natural surfactant, suggesting that lucinactant could act an alternative to natural surfactants. Lucinactant was approved by the U. S. Food and Drug Administration in March 2012 as the fifth surfactant to treat neonatal RDS. CHF5633, a second-generation synthetic surfactant containing SP-B and SP-C analogs, was effective and safe in a human multicenter cohort study for preterm infants. Many comparative studies of natural surfactants used worldwide have reported different efficacies for different preparations. However, these differences are believed to due to site variations, not actual differences. The more important thing than the composition of the surfactant in improving outcome is the timing and mode of administration of the surfactant. Novel synthetic surfactants containing synthetic phospholipid incorporated with SP-B and SP-C analogs will potentially represent alternatives to natural surfactants in the future, while improvement of treatment modalities with less-invasive or noninvasive methods of surfactant administration will be the most important task to be resolved.

Effects of Lipomyces starkeyi KSM 22 Glucanhydrolase on human gingival fibroblasts (Lipomyces starkeyi KSM 22 Glucanhydrolase 용액의 치은 섬유아세포에 대한 영향)

  • Yun, Hyun-Jeong;Chung, Hyun-Ju;Kim, Ok-Su;Kim, Do-Man
    • Journal of Periodontal and Implant Science
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    • v.32 no.3
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    • pp.665-683
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    • 2002
  • A novel glucanhydrolase from a mutant of Lipomyces starkeyi KSM 22 has additional amylase activity besides mutanolytic activity and has been suggested as promising anti-plaque agent. It has been shown effective in hydrolysis of mutan, reduction of mutan formation by Streptococcus mutans and removal pre-formed sucrose-dependent adherent microbial film and has been strongly bound to hydroxyapatitie. These in vitro properties of Lipomyces starkeyi KSM 22 glucanhydrolase are desirable for its application as a dental plaque control agent. In human experimental gingivitis model and 6 month clinical trial, mouthrinsing with Lipomyces starkeyi KSM 22 dextranase was comparable to 0.12% chlorhexidine mouthwash in inhibition of plaque accumulation and gingival inflammation and local side effect was negligible. This study was aimed to evaluate the cytotoxic effect of Lipomyces starkeyi KSM 22 glucanhydrolase on human gingival fibroblasts. Primary culture of human gingival fibroblasts at the 4th to 6th passages were used. Glucanhydrolase solution was made from lyophilized glucanhydrolase powder from a mutant of Lipomyces stakeyi KSM 22 solved in PBS and added to DMEM medium to the final concentration of 0.5, 1, and 2 unit. Cells were exposed to glucanhydrolase solution or 0.1 % chlorhexidine and the cells cultured in DMEM with 10% FBS and 1% antibiotics as control. After exposure, the morphological change, cell attachment, and cell activity by MTT assay were evaluated in 0.5, 1.5, 3, 6, 24 hours after treatment. The cell proliferation and cell activity was also evaluated at 2 and 7 days after 1 minute exposure, twice a day. The cell morphology was similar between the Lipomyces smkeyi KSM 22 glucanhydrolase groups and control group during the incubation periods, while most fibroblasts remained as round cell regardless of incubation time in the chlorhexidine group. The numbers of the attached cells in the glucanhydrolase groups were comparable to that of control and significantly higher than the chlorhexidine group. The numbers of the proliferated cells in the glucanhydrolase groups at 7 days of incubation were comparable to the control group and higher than the chlorhexidine group. The cell activity in glucanhydrolase groups paralleled with the increased cell number by attachment and proliferation. According to these results, Lipomyces starkeyj KSM 22 glucanhydrolase has little harmful effect on attachment and proliferation of human gingival fibroblasts, in contrast to 0.1% chlorhexidine which was cytotoxic to human gingival fibroblasts. Therefore this glucanhydrolase preparation is considered as a safe and promising agent for new mouthwash formula in the near future.

Agrobacterium sp.-derived β-1,3-glucan enhances natural killer cell activity in healthy adults: a randomized, double-blind, placebo-controlled, parallel-group study

  • Lee, Yeon Joo;Paik, Doo-Jin;Kwon, Dae Young;Yang, Hye Jeong;Park, Yongsoon
    • Nutrition Research and Practice
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    • v.11 no.1
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    • pp.43-50
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    • 2017
  • BACKGROUND/OBJECTIVES: The present study investigated the hypothesis that a highly pure linear ${\beta}$-1,3-glucan produced by Agrobacterium sp. R259 enhances human natural killer (NK) cell activity and suppresses pro-inflammatory cytokines. SUBJECTS/METHODS: In an eight-week, double-blind, randomized, placebo-controlled clinical trial, 83 healthy adults with white blood cell counts of $4,000-8,000cells/{\mu}L$ were participated and randomly assigned to take two capsules per day containing either 350 mg ${\beta}$-1,3-glucan or placebo. Six participants withdrew their study consent or were excluded due to NK cell activity levels outside the normal range. NK cell activity and serum levels of immunoglobulin G (IgG) and cytokines, such as interferon (IFN)-${\gamma}$, interleukin (IL)-2, IL-4, IL-6, IL-10, IL-12 and tumor necrosis factor (TNF)-${\alpha}$ were measured. RESULTS: NK cell activity and the serum levels of IL-10 were significantly higher from baseline to week 8 in the ${\beta}$-glucan group compared with the placebo group (P = 0.048, P = 0.029). Consumption of ${\beta}$-1,3-glucan also significantly increased NK cell activity compared with placebo after adjusting for smoking and stress status (P = 0.009). In particular, the effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants with severe stress than in those experiencing mild stress. However, the administration ${\beta}$-1,3-glucan did not significantly modulate the levels of IFN-${\gamma}$, IL-2, IL-4, IL-6, IL-12, TNF-${\alpha}$ and IgG compared with the placebo. CONCLUSION: The results showed that supplementation with bacterial ${\beta}$-1,3-glucan significantly increased NK cell activity without causing any adverse effects. Additionally, the beneficial effect of ${\beta}$-1,3-glucan on NK cell activity was greater in participants experiencing severe stress.

A Clinical Trial of Orally Administered Alkaline Reduced Water

  • Yang, Eun-Ju;Kim, Jung-Rye;Ryang, Yong-Seok;Kim, Dong-Heui;Deung, Young-Kun;Park, Seung-Kyu;Lee, Kyu-Jae
    • Biomedical Science Letters
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    • v.13 no.2
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    • pp.83-89
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    • 2007
  • Effects of alkaline reduced water (ARW) on the scavenging of reactive oxygen species (ROS) and diabetes were recently reported. However, no studies have yet been investigated on general drinking effects. In this study, we examined 100 patients hospitalized for senile disease treatment and recuperation. All examines received the ARW for 2 months. WBC level was decreased from $6.34\pm1.9(\times10^9/L)$ to $5.66\pm1.7(\times10^9/L)$. SGPT level was decreased from 27.47$\pm$14 Ut to 23.95$\pm$8.8 U/L. Cholesterol level was increased from 167.9$\pm$32 mg/dl to 176.21$\pm$42 mg/dl within normal range. However, the levels of potassium, adiponectin, SGOT and blood pressure showed no significant difference. The levels of growth hormone and homocysteine and mini-mental state examination also showed no significant difference. We suppose that the slight blood parameter trends indicate an improved physical condition induced by the ARW. Furthermore, we could found no harmful effect of the ARW in this study.

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Study on the Safety of Bojungbangdocktang Ethanol Extract (보정방독탕 에탄올 추출물의 안전성에 대한 연구)

  • Lee, Eun-Ok;Lee, Hyo-Jeong;Lee, Hyo-Jung;Jeong, Soo-Jin;Choi, Do Young;Jung, Hee-Jae;Ahn, Kyoo-Seok;Kang, Jong-Gu;Kim, Sung-Hoon
    • Journal of Korean Traditional Oncology
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    • v.15 no.1
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    • pp.37-45
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    • 2010
  • Bojungbangdocktang (BJBDT), a formula of eight Oriental herbs, is a modified herbal prescription of Bangdoktang and Bojungbangamtang. Recently, BJBDT was demonstrated to inhibit angiogenesis induced by vascular endothelial growth factor in human umbilical vein endothelial cells, enhance hematopoiesis and protect cisplatin-induced cytotoxicity in normal MCF-10A breast cells. Nevertheless, there is no safety study of BJBDT before clinical trial so far. Thus, in the current study, we investigated the toxicity about ethanol-extracted BJBDT. Male and female Spraque Dawley (SD) rats were given orally by BJBDT at 250, 500, and 1000 mg/kg for 4 weeks. Mortality, clinical signs and measured change of body weight, food consumption and water consumption were observed. In addition, we performed ophthalmologic, urinary, hematological, blood serum biochemical and histopathological examination. Any general toxicity was not found in BJBDT treated group. Also, there were no significant differences in the parameters such as body weight, food consumption and water consumption, a lot of urine and blood factor levels except HCT, MCHC, Ca, TG, Glucose and T-Bilirubin level compared with control group. Although HCT was elevated and TG was decreased in male rats, and MCHC, Glucose and T-Bilirubin were elevated and Ca and HCT were decreased in female rats, these were within normal ranges. Finally, we determined that maximum tolerated dose (MTD) was 1000 mg/kg and no observed adverse effect level (NOAEL) was 500 mg/kg. Taken together, these results demonstrated that BJBDT is very safe to SD rats.

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Study on the Safety of Kamikaekyuk-tang Ethanol Extract (가미계격탕 주정추출물의 안전성에 대한 연구)

  • Lee, Eun-Ok;Seo, Nam-Jun;Jung, Hee-Jae;Kang, Jong-Gu;Kim, Sung-Hoon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.23 no.4
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    • pp.799-804
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    • 2009
  • Kamikaekyuk-tang(KMKKT), a formula of ten Oriental herbs, was orientally designed to promote vital energy, to remove blood stasis, and to decrease inflammation for treating cancers. KMKKT and its component had potent antiandrogen and androgen receptor activities in prostate cancer and also inhibited angiogenesis induced by basic fibroblast growth factor (bFGF) in human umbilical vein endothelial cells and suppressed the tumor growth in LLC-bearing mice, and liver metastasis of colon 26-L5 cancer cells, suggesting a potent cancer preventive agent. Nevertheless, there is no safety study of KMKKT before clinical trial so far. Thus, in the current study, we investigated the toxicity about ethanol-extracted KMKKT. Male and female Spraque Dawley (SD) rats were given orally by KMKKT at 250, 500, and 1000 mg/kg for 4 weeks. Mortality, clinical signs and measured change of body weight, food consumption and water consumption were observed. In addition, we performed ophthalmologic, urinary, hematological, blood serum biochemical and histopathological examination. Any general toxicity was not found in KMKKT treated group. Also, there were no significant differences in the parameters such as body weight, food consumption and water consumption, a lot of urine and blood factor levels except WBC, MCHC and Ca level compared with control group. Although WBC and MCHC were elevated in female rats and Ca level was decreased in male rats, these were within normal ranges. Finally, we determined that maximum tolerated dose (MTD) was 1000 mg/kg and no observed adverse effect level (NOAEL) was 500 mg/kg. Taken together, these results demonstrated that KMKKT is very safe to SD rats.

Effect of yoghurt with a Bifidobacteria enhancer and dietary fiber on irritable bowel syndrome

  • Cho, Young Hoon;Bae, Hyoung Churl;Nam, Myoung Soo
    • Korean Journal of Agricultural Science
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    • v.48 no.3
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    • pp.575-587
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    • 2021
  • This study was carried out to investigate the effects of supplementation with a Bifidobacteria enhanced yogurt (BE0623 yogurt), which includes Bifidobacterium lactis BB12, Lactobacillus acidophilus, Streptococcus thermophilus, and Bifidobacterium lactis, in the management of irritable bowel syndrome (IBS) using animal models and clinical trials. In a rat study, a loperamide-treated group (LOP) showed reduced water content in fecal pellets but showed an increased number of fecal pellets in the distal colon. In addition, the BE0623 yogurt (L-BE0623Y) group had the fewest fecal pellets in the distal colon. Regarding the serum lipid parameters, the LOP group had a high-density lipoprotein (HDL)/total cholesterol ratio that was 43% lower than that of a normal water group (NOR), but the outcome for the L-BE0623Y group was 27% lower than the NOR group. In a human study, 116 adults with IBS were sampled as subjects and fed 300 mL of yogurt per day for an eight week period. There was an IBS improvement in the L-BE0623Y and commercial yogurt (L-CY) groups, though flatulence, stool consistency and frequency of defecation outcomes were also noted. Specifically, the L-BE0623Y treatment group showed significant effects with regard to defecation duration and urgency after the consumption of the yogurt used in this study. These results suggest that the Bifidobacteria-enhanced yogurt has superior effects with regard to relieving loperamide-induced constipation in rats and that regular consumption of L-BE0623Y is effective to improve IBS in humans.