• 제목/요약/키워드: Clinical trial center

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봉독을 이용한 무작위배정 임상연구의 국내 현황 (The Review on the Randomized Controlled Clinical Trials of Bee Venom in the Journal of Korean Medicine)

  • 이용석;이영준;한창현
    • 한방재활의학과학회지
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    • 제23권3호
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    • pp.87-106
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    • 2013
  • Objectives We will provide basic information on bee venom clinical tests and aid the practical use of bee venom in such tests, through examination of RCT research related to bee venom that was reported domestically. Methods We collected 365 articles on Bee venom study result from the OASIS system using the Keyword 'bee venom, apitoxin, apitherapy, bee sting'. The initially selected theses were primarily screened for clinical research. Out of these, case studies and non randomized controlled trial (non-RCT) were ruled out. As a result, 39 studies of randomized controlled trial (RCT) research were chosen as the subjects of study. Results RCT research related to bee venom was first presented in 2003, and 39 studies have been published until 2012. 18 studies were tests to confirm the effectiveness of bee venom, 7 studies were comparisons between SBV and BV, and 13 studies were comparisons with other types of treatment. Research conducted through appropriate randomization methods were 20 studies, and inappropriate randomization methods were used in 19 studies. In therms of Jadad score, 12 studies received 4~5 points, 15 studies received 1-3 points, and 12 studies received zero point. Conclusions In order to assure good quality RCT research, appropriate guidelines should be provided, and proper evaluation standards should be established. In-depth study is needed concerning the difference of responses to treatment according to the types of treatment received. A standardization of treatment should be reached as a result.

Preliminary Study on Effectiveness of Dexamethasone-Soaked Gelatin Sponges for Reducing Pain after Lumbar Microdiscectomy : A Randomized Controlled Trial

  • Shin, Dong-Ah;Gong, Tae-Sik;Shin, Dong-Gyu;Kwon, Chang-Young;Kim, Hyoung-Ihl
    • Journal of Korean Neurosurgical Society
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    • 제39권1호
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    • pp.11-15
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    • 2006
  • Objective : A prospective, randomized, controlled clinical study is performed to verify the effectiveness of epidural dexamethasone-soaked gelatin sponges to reduce postoperative pain following lumbar microdiscectomy. Methods : Twenty-three patients (10 men and 13 women) undergoing lumbar microdiscectomy were included. Five pieces of gelatin sponge measuring $1{\times}1cm$ [Gelfoam; Pharmacia & Upjohn. Kalamazoo, MI, USA], soaked with either 5mg dexamethasone or an equal amount [2mL] of saline, were left on the decompressed nerve root after unilateral hemilami-nectomy, flavectomy and discectomy. Results : Subjective visual analog scale[VAS] scores of leg pain in the dexamethasone group on the first, third and first postoperative days [2.5, 2.5, 1.7, respectively] were significantly lower than in the control group [5.0, 4.8, 3.6][P<0.05]. No side effects related to the dexamethasone-soaked gelatin sponges were observed. Conclusion : The intraoperative application of dexamethasone-soaked gelatin sponges during lumber microdiscetomy can provide effective-postoperative analgesia without complications.

폐경 후 고혈압 전단계 및 1기 고혈압에 대한 침 치료 효과: 무작위 대조 예비연구 (Acupuncture for Prehypertension and Stage 1 Hypertension in Postmenopausal Women: A Randomized Controlled Pilot Trial)

  • 김정은;최선미;최진봉;김형준;권오진;김재홍;박지은
    • Korean Journal of Acupuncture
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    • 제34권3호
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    • pp.116-125
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    • 2017
  • Objectives : The aim of this study was to assess the effectiveness of acupuncture in treating prehypertension and stage 1 hypertension in postmenopausal women. Methods : The study was a multi-center, four-arm, non-blinded, randomized clinical trial. Sixty participants were randomly assigned to experimental or control groups. The experimental groups received 10 acupuncture sessions over 4 weeks(Group A, n=20) or 20 sessions over 8 weeks(Group B, n=20) along with usual care. The acupoints were GB20, LI11, ST36, and SP6, bilaterally. The acupuncture groups were followed-up for an additional 12 weeks after acupuncture treatment. The control groups received usual care for 16 weeks(Group C, n=10) or 20 weeks(Group D, n=10). The outcomes were blood pressure, blood pressure control rates, lipid profile, and high-sensitivity C-reactive protein(hs-CRP). Results : After 4 weeks, DBP in the acupuncture groups(A+B) showed no significant decrease compared to the control group(C+D). However, after 8 weeks of acupuncture treatment, group B showed a significant decrease in DBP after acupuncture treatment and follow-up period compared to control group. Although there was no difference between the acupuncture and control groups in SBP after acupuncture treatment, group B showed a significant decrease in SBP compared to control group after follow-up period. Lipid profiles and hs-CRP did not differ significantly between acupuncture and control groups. Conclusions : Acupuncture treatment for 8 weeks showed the effect on prehypertension and mild hypertension. To verify the effect of acupuncture on blood pressure, rigorous trials including more participants are required.

A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds

  • Pak, Changsik;Park, Jihoon;Hong, Jinmyung;Jeong, Jaehoon;Bang, Saik;Heo, Chan Yeong
    • Archives of Plastic Surgery
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    • 제42권6호
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    • pp.721-728
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    • 2015
  • Background We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds. Methods In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests. Results Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane. Conclusions In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings.

한의원에서 사용 가능한 정량적인 월경곤란증 평가지표 개발 (A Study for Suggestion of Quantitative Scale for Dysmenorrhea in Clinics)

  • 박정수;박선주;김경훈;김운지;최형심;최한석;최윤경;조정훈;신용철;고성규
    • 대한한방부인과학회지
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    • 제24권1호
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    • pp.144-161
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    • 2011
  • Objectives: Oriental Medicine has thousands years of history. But this era, every medical decision should be based on scientific evidence, that is evidence-based medicine (EBM). This study is to suggest quantitative case report form for dysmenorrhea that can be easily used in clinics. Methods: First, to search published papers in Korea and overseas, OASIS, KISS and NCBI(pubmed) database. Second, to search clinical trials in clinical trial register website, ISRCTN and clinicaltrials.gov. Result: Visual Analogue Scale(VAS) is the most commonly used scale. Conclusion: The main scales for dysmenorrhea are Visual Analogue Scale(VAS), Multidimensional verbal Rating scale(MVRS), pain-killer intake amount and restriction of daily life activities. To measure the effect of herbal medicine, more than 2 menstrual cycle is recommended.

In vitro Stimulation of NK Cells and Lymphocytes Using an Extract Prepared from Mycelial Culture of Ophiocordyceps sinensis

  • Sun-Hee Jang;Jisang Park;Seung-Hwan Jang;Soo-Wan Chae;Su-Jin Jung;Byung-Ok So;Ki-Chan Ha;Hong-Sig Sin;Yong-Suk Jang
    • IMMUNE NETWORK
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    • 제16권2호
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    • pp.140-145
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    • 2016
  • Ophiocordyceps sinensis is a natural fungus that has been valued as a health food and used in traditional Chinese medicine for centuries. The fungus is parasitic and colonizes insect larva. Naturally occurring O. sinensis thrives at high altitude in cold and grassy alpine meadows on the Himalayan mountain ranges. Wild Ophiocordyceps is becoming increasingly rare in its natural habitat, and its price limits its use in clinical practice. Therefore, the development of a standardized alternative is a great focus of research to allow the use of Ophiocordyceps as a medicine. To develop an alternative for wild Ophiocordyceps, a refined standardized extract, CBG-CS-2, was produced by artificial fermentation and extraction of the mycelial strain Paecilomyces hepiali CBG-CS-1, which originated from wild O. sinensis. In this study, we analyzed the in vitro immune-modulating effect of CBG-CS-2 on natural killer cells and B and T lymphocytes. CBG-CS-2 stimulated splenocyte proliferation and enhanced Th1-type cytokine expression in the mouse splenocytes. Importantly, in vitro CBG-CS-2 treatment enhanced the killing activity of the NK-92MI natural killer cell line. These results indicate that the mycelial culture extract prepared from Ophiocordyceps exhibits immune-modulating activity, as was observed in vivo and this suggests its possible use in the treatment of diseases caused by abnormal immune function.

방풍통성산 및 대시호탕의 항비만효과 분석: 단일기관 무작위배정 이중맹검 임상시험 프로토콜 (The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial)

  • 오지홍;심혜윤;차지윤;김호석;김민지;안은경;이명종;이준환;김호준
    • 한방비만학회지
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    • 제20권2호
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    • pp.138-148
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    • 2020
  • Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.

성인 호흡곤란 증후군에 있어 체외막 산소화 장치를 이용한 치료 (The Treatment of Adult Respiratory Distress Syndrome (ARDS) Using Extracorporeal Membrane Oxygenation (ECMO))

  • 김고운;최은영;홍상범
    • Tuberculosis and Respiratory Diseases
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    • 제72권1호
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    • pp.1-7
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    • 2012
  • Extracorporeal Membrane Oxygenation (ECMO) support to tissue oxygenation has been shown to improve survival in patients with life threatening respiratory distress syndrome or cardiac failure. Extracorporeal life support such as ECMO, including extracorporeal $CO_2$ removal ($ECCO_2R$), is used as temporary support until successful recovery of organs. A recently published multicentre randomized controlled trial, known as the CESAR (conventional ventilation or extracorporeal membrane oxygenation for severe adult respiratory failure) trial, was the first trial to demonstrate the utility of ECMO in acute respiratory distress syndrome (ARDS). During the 2009 influenza A (H1N1) pandemic, there were many reports of patients with severe ARDS related to H1N1 infection treated with ECMO. These reports revealed a high survival rate and effectiveness of ECMO. In this review, we explain the indication of ECMO clinical application, the practical types of ECMO, and complications associated with ECMO. In addition, we explain recent new ECMO technology and management of patients during ECMO support.

일반적인 체외수정 방법과 세포질내 정자주입술로 얻어진 배아의 동결-융해 후 이식의 결과 (Results of Transfer of Cryopreserved Supernumerary Embryos Obtained after Conventional in vitro Fertilization and Intracytoplasmic Sperm Injection (ICSI))

  • 김정욱;한미현;변혜경;전진현;손일표;궁미경;백은찬;강인수;이호준
    • Clinical and Experimental Reproductive Medicine
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    • 제24권1호
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    • pp.111-118
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    • 1997
  • Intracytoplasmic sperm injection (ICSI) recently has been utilized widely as the most successful technique to overcome the unfertilization problem in cases of severe male infertility in couples who could not be treated by conventional IVF. Recently, indications of ICSI have been extended further and more fertilized oocytes become available. Thus, it is necessary to examine the efficiency of freezing the surplus embryos obtained from ICSI. We compared the survival rate and the future outcome of cryopreserved embryos obtained either after conventional IVF or ICSI during the same period. After ICSI or IVF, five best-quality embryos from each patient were transferred in the stimulation cycle and the surplus pronuclear (PN) stage oocytes or multicellular embryos were cryopreserved by slow freezing protocol with 1,2-propanediol (PROH) as a cryoprotectant. A total of 792 embryos from ICSI trial were thawed and 65.2% (516/792) survived. The survival rates of PN stage oocyte, multicellular embryo and PN + multicellular embryo were 63.5%, 68.2%, 64.0%, respectively. After 111 transfers, 34 pregnancies were achieved, corresponding to a clinical pregnancy rate of 30.6% per transfers. We thawed 1033 embryos from IVF trials and 57.5% (594/1033) survived. In IVF cycle, the survival rates of PN stage oocyte, multicellular embryo and PN + multicellular embryo were 58.2%, 65.2%, 40.2%, respectively. Thirty eight clinical pregnancies were established after 134 transfers, corresponding to a pregnancy rate of 28.4% per transfer. The cleavage rate of thawed PN stage oocytes from ICSI trial (61.3%) was significantly higher than those from conventional IVF (53.4%). The developmental rates of good embryo (${\geqq}$ grade II) in thawed PN stage oocytes obtained from conventional IVF and ICSI were 63% and 65%, respectively. We concluded that PN stage oocytes, multicellular embryos resulting from ICSI procedure can be successfully frozen/thawed with reasonable clinical pregnancy rates comparable to those of IVF.

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유기농법에 의해 재배된 열무김치의 품질 및 기능적 특성 (Physiochemical and Quality Characteristics of Young Radish (Yulmoo) Kimchi Cultivated by Organic Farming)

  • 정수진;소병옥;신상욱;노순옥;정은수;채수완
    • 한국식품영양과학회지
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    • 제43권8호
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    • pp.1197-1206
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    • 2014
  • 유기농법으로 재배한 친자연개발퇴비열무(YR-FNC), 일반퇴비열무(YR-GC)와 일반관행농법인 화학비료로 재배한 일반열무(YR-Control)로 김치를 제조하여 발효기간의 경과에 따른 품질특성, 관능적 특성 및 기능성에 대한 차이를 관찰하였다. 열무의 일반영양성분 중 수분 및 조단백질의 함량은 유기농 열무(YR-FNC, YR-GC)보다 일반열무(YRControl)에서 높았으나 식이섬유소 및 비타민 C의 함량은 유기농 열무에서 높았다. 무기질 중 인과 구리의 함량은 유기농 열무가 높은 반면 질소, 칼륨, 칼슘, 마그네슘, 철, 망간 및 아연의 함량은 일반열무(YR-Control)에서 높게 나타났다. 일반열무김치(YR-Control)는 발효진행의 속도가 빠르게 진행이 되어 적숙기 pH에 빨리 도달하였고, 유기농 열무김치(YR-FNC, YR-GC)는 발효가 서서히 진행되어 저장성이 길어지는 경향을 확인하였다. 당초 열무김치 담금 초기(0일)부터 열무김치의 총 폴리페놀과 총 플라보노이드의 함량은 유기농 열무김치(YR-FNC, YR-GC)의 경우 일반열무김치(YR-Control)에 비해 약 1.5~3배가 높은 수준으로 나타났으며 발효기간이 경과되면서 일반열무김치(YR-Control)와 유기농 열무김치(YR-FNC)에서 유의적으로 증가하였다. 김치 발효 7일째에 김치의 젖산균인 lactic acid bacteria 함량과 총 균수(total microbial)는 일반열무김치(YRControl)에 비해 유기농 열무김치(YR-FNC)에서 높은 수준이었다. 발효기간이 경과하면서 유기농 열무김치는 관능적 품질의 특성이 우수하였고 저장성을 연장시킬 수 있는 가능성을 시사한다. 따라서 일반관행농법으로 재배한 일반열무 김치에 비해 유기농 열무김치를 섭취함으로써 맛의 증진 효과뿐만 아니라 고기능성 생리활성물질을 높게 섭취할 수 있어 기능성식품 소재로서의 개발 가능성을 기대할 수 있을 것으로 사료된다.