• Title/Summary/Keyword: Clinical trial pharmacy

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Assessment of the Therapeutic Potential of Persimmon Leaf Extract on Prediabetic Subjects

  • Khan, Mohd M.;Tran, Bao Quoc;Jang, Yoon-Jin;Park, Soo-Hyun;Fondrie, William E.;Chowdhury, Khadiza;Yoon, Sung Hwan;Goodlett, David R.;Chae, Soo-Wan;Chae, Han-Jung;Seo, Seung-Young;Goo, Young Ah
    • Molecules and Cells
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    • v.40 no.7
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    • pp.466-475
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    • 2017
  • Dietary supplements have exhibited myriads of positive health effects on human health conditions and with the advent of new technological advances, including in the fields of proteomics, genomics, and metabolomics, biological and pharmacological activities of dietary supplements are being evaluated for their ameliorative effects in human ailments. Recent interests in understanding and discovering the molecular targets of phytochemical-gene-protein-metabolite dynamics resulted in discovery of a few protein signature candidates that could potentially be used to assess the effects of dietary supplements on human health. Persimmon (Diospyros kaki) is a folk medicine, commonly used as dietary supplement in China, Japan, and South Korea, owing to its different beneficial health effects including anti-diabetic implications. However, neither mechanism of action nor molecular biomarkers have been discovered that could either validate or be used to evaluate effects of persimmon on human health. In present study, Mass Spectrometry (MS)-based proteomic studies were accomplished to discover proteomic molecular signatures that could be used to understand therapeutic potentials of persimmon leaf extract (PLE) in diabetes amelioration. Saliva, serum, and urine samples were analyzed and we propose that salivary proteins can be used for evaluating treatment effectiveness and in improving patient compliance. The present discovery proteomics study demonstrates that salivary proteomic profile changes were found as a result of PLE treatment in prediabetic subjects that could specifically be used as potential protein signature candidates.

Comparison of Forced Vital Capacity and Maximal Voluntary Ventilation Between Normal and Forward Head Posture (정상자세와 머리전방자세 사이의 강제폐활량과 최대 수의적 환기량 비교)

  • Han, Jin-Tae;Go, Min-Ji;Kim, Yeong-Ju
    • Journal of the Korean Society of Physical Medicine
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    • v.10 no.1
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    • pp.83-89
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    • 2015
  • PURPOSE: The purpose of this study was to investigate the vital capacity and maximal voluntary ventilationin subjects with forward head posture (FHP). METHODS: Twenty-eight subjects participated in this study (normal 14, FHP 14) and were resident in B city. The mean age, height and weight of subjects was 22.80yrs, 169.36cm and 62.79kg. Subjects were asked to breath maximally for FVC and repeatedly for MVV during 12 seconds. The variables of data were collected as follows: Forced Vital Capacity(FVC), Forced Expiratory Volume in One Second($FEV_1$), $FEV_1$/FVC, Maximal Voluntary Ventilation(MVV). Each trial was performed by 3 times and we used the means to analyze the data. The mann-whitney U test and independent t-test were used to compare the vital capacity between normal and FHP subjects. All statistical analyses were performed using SPSS 21.0 for window versionand p-values less than 0.05 were used to identify significant differences. RESULTS: The FVC, $FEV_1$, $FEV_1$/FVC and MVV of FHP subjects were decreased more than that of normal subjects and the difference was statistically significant between two groups. CONCLUSION: The vital capacity of subjects with FHP was generally lower than normal subjects. This study shows that the vital capacityof subjectswith FHP could be decreased due to the bad neck posture that weakens the respiratory accessory muscles of neck.

A network pharmacology and molecular docking approach in the exploratory investigation of the biological mechanisms of lagundi (Vitex negundo L.) compounds against COVID-19

  • Robertson G. Rivera;Patrick Junard S. Regidor;Edwin C. Ruamero Jr;Eric John V. Allanigue;Melanie V. Salinas
    • Genomics & Informatics
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    • v.21 no.1
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    • pp.4.1-4.18
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    • 2023
  • Coronavirus disease 2019 (COVID-19) is an inflammatory and infectious disease caused by severe acute respiratory syndrome coronavirus 2 virus with a complex pathophysiology. While COVID-19 vaccines and boosters are available, treatment of the disease is primarily supportive and symptomatic. Several research have suggested the potential of herbal medicines as an adjunctive treatment for the disease. A popular herbal medicine approved in the Philippines for the treatment of acute respiratory disease is Vitex negundo L. In fact, the Department of Science and Technology of the Philippines has funded a clinical trial to establish its potential as an adjunctive treatment for COVID-19. Here, we utilized network pharmacology and molecular docking in determining pivotal targets of Vitex negundo compounds against COVID-19. The results showed that significant targets of Vitex negundo compounds in COVID-19 are CSB, SERPINE1, and PLG which code for cathepsin B, plasminogen activator inhibitor-1, and plasminogen, respectively. Molecular docking revealed that α-terpinyl acetate and geranyl acetate have good binding affinity in cathepsin B; 6,7,4-trimethoxyflavanone, 5,6,7,8,3',4',5'-heptamethoxyflavone, artemetin, demethylnobiletin, gardenin A, geranyl acetate in plasminogen; and 7,8,4-trimethoxyflavanone in plasminogen activator inhibitor-1. While the results are promising, these are bound to the limitations of computational methods and further experimentation are needed to completely establish the molecular mechanisms of Vitex negundo against COVID-19.

A Clinical Practice Guideline for Ma-huang(Ephedra sinica) Prescription in Obesity (비만치료 및 체중감량에서의 적절한 마황 사용에 대한 임상 진료지침 개발)

  • Kim, Ho-Jun;Han, Chang-Ho;Lee, Eui-Ju;Song, Yun-Kyung;Shin, Byung-Cheul;Kim, Yun-Kyung
    • Journal of Korean Medicine for Obesity Research
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    • v.7 no.2
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    • pp.27-37
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    • 2007
  • Background Clinical practice guidelines (CPG) are systematically developed statements to assist practitioners and patients on healthcare decisions. They provide recommendations for the average patient, which should take into account individual clinical judgment and the patient's values and expectations. Ephedra has sympathomimetic effect and has been used for weight loss worldwide. However, its safety is controversial especially in autonomic and cardiovascular systems. Therefore, the need of appropriate CPG for ephedra prescription in obesity was advocated in Korean Traditional Medicine. Methods The committee comprised of specialists of obesity, oriental herbology, oriental cardiology, constitutional medicine. The committee collected all relevant references about adverse effect and safety of ephedra in the forms of meta-analysis, systematic review, randomized controlled trial, case-control study and observational study from international and domestic databases and paper journals. 11 English- and 5 Korean-language references were gathered and categorized by PICO (Patient, Intervention, Comparison, Outcome) method. We could not complete strength of recommendation which should be clarified according to the evidence grade estimation. Result The first version of CPG for ephedra prescription in obesity was issued by Korean Oriental Association for Study of Obesity. It includes topics of introduction, pharmacokinetics, side effects and adverse events, constitutional aspect and recommendations for dose, indication and contraindication. Conclusion There should be periodic upgrade of this CPG from now on. Although there are some drawbacks in this version of CPG, it has significance as the first CPG in Korean Traditional Medicine.

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Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study (궁하탕정의 단회 경구투여 후 안전성 평가를 위한 단일기관 연구)

  • An, Sung-Hu;Shin, Hee-Ra;Park, Kyungtae;Lee, Yoon-Seung;Kim, Jonggyu;Yeom, Seung-Ryong;Kwon, Young-Dal;Cho, Hea-Young
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.4
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    • pp.101-108
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    • 2019
  • Objectives The purpose of this study is to evaluate the safety of Gunghatang tablet in healthy male volunteers. Methods Single center pharmacokinetics study was carried out in healthy male volunteers. Through the laboratory test, vital sign and adverse event data, safety evaluation was conducted. Total 15 of 16 subjects who met the inclusion criteria were enrolled and three subjects were allocated to waiting group. 12 subjects were allocated by serial number according to registration order. Subjects took the maximum daily dose of the tablet on the second day of hospitalization. For the evaluation of safety, blood samples were collected and vital sign were checked 4 times (screening, before administration, after administration and follow up period) during the trial. All adverse events were recorded and summarized as frequency and percentage. All continuous data were summarized as mean and standard deviation. For comparison of variables between before administration and after administration, data were analyzed by paired T-test or Wilcoxon signed rank test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, there were no significant differences associated with the clinical trial drug between pre and post administration. And there was no adverse event associated with the clinical trial drug. Conclusions Gunghatang tablet were found to be safe for healthy male volunteers.

Cytotoxic Effects of an Oncolytic Adenoviral Vector AdLPCDIRESE1A in Hepatocellular Carcinoma Cells (암세포 용해성 AdLPCDIRESE1A 벡터의 간암 세포독성효과)

  • Chung, In-Jae
    • YAKHAK HOEJI
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    • v.55 no.1
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    • pp.75-79
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    • 2011
  • The replication competent adenoviral vector (AV), AdLPCDIRESE1A was generated and reported previously to have cytotoxic effects in some cell lines. In AdLPCDIRESE1A, the expression of cytosine deaminse (CD) and E1A genes are under the control of tumor-specific L-plastin promoter. CD enzyme can deaminate the nontoxic prodrug 5-fluorocytosine (5-FC) to the toxic 5-fluorouracil (5-FU). E1A gene is essential for viral replication. Primary liver cancer, most of which is hepatocellular carcinoma (HCC), is the third common leading cancer in Korea. Thus, we have conducted in vitro preclinical study to evaluate effectiveness of AdLPCDIRESE1A on HCC. The efficacy of cytotoxicity was measured by generation of cytopathic effect (CPE) and cell counting. We infected HepG2 cells with various MOI of vector alone or concurrent with 5-FC. Exposure of cells to AdLPCDIRESE1A generated a significant cytotoxic effect as compared to the control. Almost 83% of the cell had manifested the characteristic cytotoxic effect on day 9 after infection of cells with 10 MOI of vector. We also observed the additive cytotoxic effects when AdLPCDIRESE1A vector had been coadministrated with 5-FC. The results suggest that the use of AdLPCDIRESE1A/5FC may be value in treatment of liver cancer. Further animal studies are needed for clinical trial.

Bitam-S Improves the Non-alcoholic Fatty Liver Disease in C57BL/6J ob/ob Mice (Ob/ob Mouse에서 비탐-에스의 비 알코올성 지방간 개선 활성)

  • Han, Eun-Jung;Kim, Ae-Kyung;Chung, Sung-Hyun
    • YAKHAK HOEJI
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    • v.49 no.4
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    • pp.306-311
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    • 2005
  • Semisulospira libertine (SL) has been used as a folk medicine for quenching a thirst, hepatic fever and inflammation in oriental countries. Although SL has been anecdotally ascertained to ameliorate the hepatic diseases, there are no sufficient experimental evidences. The purpose of this study was to examine the effect of Bitam-S, in which SL is a main component, on non-alcoholic fatty liver disease manifested in C57BL/6J ob/ob mice. At 6 week old, the ob/ob mice were randomly divided into four groups; control and three treatment groups. The control mice was to receive a regular diet, and the treatment groups were fed a regular diet with either 250mg/kg, 500mg/kg of Bitam-S (BS250 and BS500) or 300mg/kg of metformin (MT300) for a 8-week period. Bitam-S exerted beneficial effects on lipid homeostasis in ob/ob mice that are not necessarily due to its ability to decrease food intake but its specific effects on hepatic lipogenesis related genes (SREBP1a, FAS and SCD-1). The combined effects of Bitam-S to reduce body weight and lipogenic gene expressions, and reduce the deposition of triglyceride in the liver are indicative of a marked improvement in obesity-related non-alcoholic fatty liver disease. Taken together, Bitam-S has potential as a treatment agent for non-alcoholic fatty liver disease and deserves clinical trial in the near future.

NEW ANTI-AGING AND ANTI-WRINKLE COSMETIC INGREDIENT : INNER NUTSHELL OF CASTANEA MOLLISIMA BL (CHESTNUT)

  • Kim, Beom-Jun;Kim, Jeong-Ha;Kim, Hyun-Pyo;Heo, Moon-Young
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.24 no.3
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    • pp.17-23
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    • 1998
  • Inner nutshell of Castanea mollisima BL (chestnut) has been used as an anti-aging and anti-wrinkle agent from the ancient time in east Asia. In order to develop new anti-aging and anti-wrinkle, ethanolic extract of inner nutshell of Castanea mollisima BL (Cor-285) was prepared and various biological activities were evaluated. Cor-285 showed potent antioxidant activity, Especially, Cor-285 possessed potent free radical scavenging activity in vitro (IC50:7.6 g/ml) compared to gallic acid (IC50:12.5 g/ml), Cor-285 showed the preventive effect against UV-induced cytotoxicity of fibroblast at concentration of 25-250 g/ml. When Cor-285 was evaluated for its anti-allergic activity, it effectively inhibited histamine release from mast cells induced by compound 48/80 (86% inhibition at 10 mg/ml). The inhibitory activity was stronger than that of glycyrrhiznate. Cor-285 also showed in vivo inhibition against delayed hypersensitivity as well as croton-oil induced ear edema in mice when topically applied These results strongly suggest that Cor-285 may reduce immunoregulatory 1 inflammatory skin trouble. From the attempts to isolate the constituents, citropten (simple coumarin) and ellagic acid, a well known radical scavenger, were isolated. In a clinical trial of twenty healthy volunteers with aged skin,6 weeks application of Cor-285 (3% cream) decreased wrinkle about 26% and increased moisturizing 20% on the skin. All of these results indicate that Cor-285 may be an effective anti-aging and anti-wrinkle agent.

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Effect of Cimetidine and Phenobarbital on Metabolite Kinetics of Omeprazole in Rats

  • Park Eun-Ja;Cho Hea-Young;Lee Yong-Bok
    • Archives of Pharmacal Research
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    • v.28 no.10
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    • pp.1196-1202
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    • 2005
  • Omeprazole (OMP) is a proton pump inhibitor used as an oral treatment for acid-related gastrointestinal disorders. In the liver, it is primarily metabolized by cytochrome P-450 (CYP450) isoenzymes such as CYP2C19 and CYP3A4. 5-Hyroxyomeprazole (5-OHOMP) and omeprazole sulfone (OMP-SFN) are the two major metabolites of OMP in human. Cimetidine (CMT) inhibits the breakdown of drugs metabolized by CYP450 and reduces, the clearance of coad-ministered drug resulted from both the CMT binding to CYP450 and the decreased hepatic blood flow due to CMT. Phenobarbital (PB) induces drug metabolism in laboratory animals and human. PB induction mainly involves mammalian CYP forms in gene families 2B and 3A. PB has been widely used as a prototype inducer for biochemical investigations of drug metabolism and the enzymes catalyzing this metabolism, as well as for genetic, pharmacological, and toxicological investigations. In order to investigate the influence of CMT and PB on the metabolite kinetics of OMP, we intravenously administered OMP (30 mg/kg) to rats intraperitoneally pretreated with normal saline (5 mL/kg), CMT (100 mg/kg) or PB (75 mg/kg) once a day for four days, and compared the pharmacokinetic parameters of OMP. The systemic clearance ($CL_{t}$) of OMP was significantly (p<0.05) decreased in CMT-pretreated rats and significantly (p<0.05) increased in PB-pretreated rats. These results indicate that CMT inhibits the OMP metabolism due to both decreased hepatic blood flow and inhibited enzyme activity of CYP2C19 and 3A4 and that PB increases the OMP metabolism due to stimulation of the liver blood flow and/or bile flow, due not to induction of the enzyme activity of CYP3A4.

A Potent Tyrosinase Inhibitor from Artocarpus Lakoocha Heartwood Extract: Comparative Evaluation of Its Melanin- Reducing Efficacy in Guinea Pigs and Humans

  • Tengamnuay, Parkpoom;Pengrungruangwong, Kumkwan;Likhitwitayawuid, Kittisak
    • Proceedings of the SCSK Conference
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    • 2003.09b
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    • pp.201-212
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    • 2003
  • The heartwood extract of Artocarpus lakoocha Roxb., which contains a potent tyrosinase inhibitor oxyresveratrol, was evaluated for its melanin-reducing efficacy in both guinea pigs and human volunteers. After 4 week-daily application of the extract dissolved in propylene glycol to the back of guinea pigs, significant reduction in melanin content was detected, with the effect greater than 3% kojic acid and solvent propylene glycol (P < 0.05). The extract was subsequently tested in female volunteers (3 groups of 20 subjects) using a parallel clinical trial with self-control. The first group received the A. lakoocha solution in propylene glycol whereas the second and the third group respectively received 0.25% licorice extract and 3% kojic acid in the same solvent. The subject in each group twice daily applied the test solution on one arm whereas the remaining arm was applied with only propylene glycol (self-control) for 12 weeks. The A. lakoocha extract was found to be the most effective agent, giving the shortest onset of significant whitening after only 4 weeks of application (P < 0.05), followed by 3% kojic acid (8 weeks) and 0.25% licorice extract (10 weeks). The whitening effect also increased with time, with the highest extent observed with A. lakoocha at week 12. The in vitro antityrosinase activity of A. lakoocha extract decreased with time upon storage at room temperature but could be stabilized by a combination of several antioxidants. In conclusion, the heartwood extract of A. lakoocha appeared to have promising potential for use as an effective and economical skin-whitening agent.

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