• 제목/요약/키워드: trial registration

검색결과 64건 처리시간 0.03초

측두하악 장애 치료를 위한 수기치료에 대한 체계적 고찰의 프로토콜 (Manual Therapy in the Treatment of Temporomandibular Disorders: A Protocol for a Systematic Review)

  • 김형석;정재영;정석희
    • 한방재활의학과학회지
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    • 제25권4호
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    • pp.41-46
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    • 2015
  • Objectives This systematic review will analyse randomised controlled trials (RCTs) of manual therapy in patients with temporomandibular disorders (TMDs) to evaluate the efficacy of this approach. Methods RCTs will be identified in the following ten databases based on searches starting with their inception: MEDLINE, EMBASE, CENTRAL, four Korean databases as KoreaMed, DBPIA, NDSL, and RISS and three Chinese databases as CNKI, VIP and Wanfang. The quality of these studies will be analysed using the Cochrane risk of bias. A meta-analysis will be conducted, and subgroup analysis will be considered if comparatively large heterogeneity is detected. Conclusions We plan to publish this systematic review in a peer-reviewed journal. Findings from this review may contribute to the treatment process in clinical situations. Trial registration number: PROSPERO 2015: CRD42015024090

Non-inferiority study of the efficacy of two hyaluronic acid products in post-extraction sockets of impacted third molars

  • Yang, Hyunwoo;Kim, Junghun;Kim, Jihong;Kim, Dongwook;Kim, Hyung Jun
    • Maxillofacial Plastic and Reconstructive Surgery
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    • 제42권
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    • pp.40.1-40.5
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    • 2020
  • Background: Hyaluronic acid (HA) is well known to exert an anti-inflammatory effect during oral wound healing and is commonly applied after tooth extraction. However, no double-blind randomized controlled study comparing two hyaluronate mouthwash products has been conducted so far. The aim of this study was to comparatively analyze the efficacy of Mucobarrier® and Aloclair® in terms of clinical symptoms. Results: A total of 112 patients were randomly assigned to assess the degree of discomfort, pain reduction, redness, burning sensation, and swelling between two groups on the day of surgery and 7 days later in a double blind test, with a total 56 Aloclair patients and 56 Mucobarrier patients. There was no statistically significant difference in the overall discomfort, degree of pain reduction, redness, burning sensation, and swelling between the Mucobarrier and Aloclair groups. Conclusion: The local application of hyaluronic acid mouth wash after wisdom tooth extraction is beneficial in reducing overall discomfort and pain reduction, and the clinical utility of Mucobarrier® is no different from Aloclair®. Trial registration: Institutional Review Board of Yonsei University College of Dentistry, 2-2018-0036. Registered 10 September 2018-prospectively registered, https://eirb.yuhs.ac/

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

  • 안성후;신희라;박경태;이윤승;김종규;염승룡;권영달;조혜영
    • 한방재활의학과학회지
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    • 제29권4호
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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.

Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial

  • Jovanovski, Elena;Smircic-Duvnjak, Lea;Komishon, Allison;Au-Yeung, Fei (Rodney);Sievenpiper, John L.;Zurbau, Andreea;Jenkins, Alexandra L.;Sung, Mi-Kyung;Josse, Robert;Li, Dandan;Vuksan, Vladimir
    • Journal of Ginseng Research
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    • 제45권5호
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    • pp.546-554
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    • 2021
  • Background: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. Methods: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. Results: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. Conclusion: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. Clinical trial registration: Clinicaltrials.gov identifier, NCT01578837;

보중익기탕연조엑스의 1회 경구투여 후 안전성 평가에 관한 단일기관 연구 (Safety of Bojungikgi-tang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study)

  • 안성후;정영진;김종규;신혜령;권영달
    • 한방재활의학과학회지
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    • 제31권4호
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    • pp.157-166
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    • 2021
  • Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

동거와 한국가족: 전국조사에서 나타난 동거자의 특성 (Implications of Cohabitation for the Korean Family: Cohabiter Characteristics Based on National Survey Data)

  • 이연주
    • 한국인구학
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    • 제31권2호
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    • pp.77-100
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    • 2008
  • 지난 약 십년사이 급변하는 한국의 가족환경 속에서 대중매체들은 혼인신고 지연 등을 포함 하여 동거(cohabitation)가 많이 증가하고 있다고 보고한다. 본 연구에서는 동거자의 특성을 검증하고, 한국가족에서 동거가 가지는 의미를 탐구하고자 하였다. 조사의 초점은 아니었지만 동거의 일면을 밝혀줄 수 있는 2개의 전국조사, 즉 혼인신고와 사회통계조사, 자료를 바탕으로 다변인 로짓분석을 실시하였다. 결과들은 대체로 서구문헌에서 제시하는 이론적 틀을 수용한다. 첫째, 동거는 이혼의 증가 등 가족제도의 전반적인 변화와 관련되어있다. 혼전동거의 비율이 초혼보다 재혼에서 높았고, 초혼과는 달리 이혼 후 재혼에서는 교육수준에 따른 혼전동거비율의 차이가 거의 없었다. 둘째, 취업이나 학력 등의 면에서 사회경제적 자원이 적은 남자들이 많은 남자들에 비하여 결혼보다 동거를 택할 확률이 대체로 높았다. 셋째, 부부간 취업, 교육수준, 연령차이 등 사회경제적 지위를 비교해 보면, 결혼커플보다 동거커플에서 성역할 평등 혹은 성역 할 반전이 더 활발한 것 같다. 학력, 취업, 가족가치관, 연령 등 동거커플들의 특성이 미혼자 및 이혼자뿐 아니라 결혼부부와도 특별히 유사하지 않다는 면에서, 현재 우리나라에서 행해지는 동거를 단순히 결혼의 연장선으로 볼 수는 없는 것 같다. 결혼을 하되 당분간 두고 본다는 의미를 넘어서, 동거를 선택할 수밖에 없는 이유가 있는 것이 아닌가 생각된다. 결혼을 유지하기 어려운 사회적 여건 때문에 동거가 확산되고 있는지, 그 원인, 과정 및 결과에 관한 보다 체계적인 후속 연구가 요청된다.

소면적 재배작물의 농약 잔류성 시험 후 작물 그룹화를 통한 외삽적용 (An Extrapolation from Crop Classifications Based on Pesticide Residues Trial Data within Vegetables in Minor Crops)

  • 박종혁;;;최정희;임건재;오창환;심재한
    • 농약과학회지
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    • 제13권1호
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    • pp.28-38
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    • 2009
  • Bifenthrin, chlorothalonil, cypermethrin, diazinon, fenvalerate, phenthoate 및 procymidone 등 7종의 농약에 대한 잔류시험을 통해 외삽적용을 위한 연구를 실시하였다. 실험을 위해 소면적 재배작물 중 잔류농약 부적합 사례가 많은 작물을 중심으로 11종의 엽채류, 5종의 근채류, 그리고 6종의 경채류를 포함한 총 22종의 작물을 선정하여 재배한 후 7종의 농약을 각각 처리하여 24시간 경과 시점을 1일로 하여 1, 3, 5, 7 일차에 수확하여 분석하였다. 실험결과 회수율은 엽채류는 $72.0{\sim}117.0%$, 경채류는 $81.3{\sim}105.0%$, 그리고 근채류는 $70.1{\sim}108.1%$ 수준이었고 검출한계는 엽채류는 0.005-0.1 mg/kg, 경채류와 근채류는 0.001-0.005mg/kg 수준이었다. 농약의 감소경향과 작물의 표면 형태학적 차이에 의한 농약 잔류특성을 파악 비교하여 선정된 작물을 고잔류군과 저잔류군으로 그룹화하였고 이 내용을 바탕으로 대상 농약들에 대하여 경채류 및 근채류 작물을 대상으로 농약데이터의 외삽을 통한 안전사용기준 및 MRL의 설정이 가능할 것으로 판단된다.

The Effect of Adding Kami-guibi-tang to Acetylcholinesterase Inhibitor Treatment on the Cognitive Function of Mild Alzheimer's Disease Patients: Study Protocol of a Randomized, Placebo-Controlled, Double-Blind Pilot Trial

  • Yang, Seung-bo;Kim, Ha-ri;Shin, Hee-yeon;Kim, Jeong-hwa;Lee, Chang-woo;Jahng, Geon-ho;Park, Seong-uk;Ko, Chang-nam;Park, Jung-mi
    • 대한한방내과학회지
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    • 제41권3호
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    • pp.326-338
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    • 2020
  • Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).

Effects of LI11 Acupuncture on CO2 reactivity in the anterior and middle cerebral arteries during hyperventilation-induced hypocapnia in normal subjects: A before and after study.

  • Kim, Gyeong-muk;Jung, Woo-Sang;Kwon, Seungwon;Jin, Chul;Cho, Seung-Yeon;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho
    • 대한한의학회지
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    • 제42권4호
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    • pp.164-175
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    • 2021
  • Objectives: The LI11 (Quchi) acupuncture point has always been included in the Seven acupoints for stroke; however, additional LI11 acupuncture research is needed. In this study, the effect of LI11 acupuncture on cerebral blood flow of the anterior cerebral arteries (ACA) and middle cerebral arteries (MCA) was investigated. Method: This study included 10 healthy young male subjects. Cerebral blood flow velocity and cerebrovascular reactivity were measured using transcranial Doppler sonography. Changes in hyperventilation-induced carbon dioxide (CO2) reactivity and modified ACA and MCA blood flow velocity at 40 mmHg (CV40), blood pressure, and heart rate were observed before and after LI11 acupuncture treatment. Results: A statistically significant increase in contralateral anterior cerebral artery CO2 reactivity (p=0.036) and decrease in contralateral middle cerebral artery CV40 (p=0.047) were observed. No significant difference in mean blood pressure was shown. A statistically significant increase in heart rate occurred after LI11 acupuncture; however, it was not clinically significant as there were negligible changes in the heart rhythm. Conclusions: LI11 acupuncture treatment could improve cerebral blood flow velocity. These results might be explained by regulating endothelium-dependent vessel dilation in the anterior cerebral artery region. Trial registration: This trial has been registered with Clinical Research Information Service, a service of the Korea Centers for Disease Control and Prevention: KCT0004494 (retrospectively registered). https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=15359

$1996{\sim}1998$년 유고슬라비아에서 실시한 한탄바이러스 불활화 백신($Hantavax^{TM}$)의 면역효과에 대한 야외시험 (A Field Efficacy Trial of Inactivated Hantaan Virus Vaccine ($Hantavax^{TM}$) Against Hemorrhagic Fever with Renal Syndrome (HFRS) in the Endemic Areas of Yugoslavia from 1996 to 1998)

  • 주용규;;;;;우영대;안창남;김훈;장양석;박승철;김민자;이은실;이호왕
    • 대한바이러스학회지
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    • 제29권2호
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    • pp.55-64
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    • 1999
  • In Yugoslavia, hemorrhagic fever with renal syndrome (HFRS) is one of the important national health problem, but no vaccine has been used to prevent HFRS. Since first HFRS case in 1952, sporadic cases of HFRS occurred every year and over 4,000 registered cases with $1{\sim}16%$ mortality so far. We performed a prospective, randomized double-blind placebo-controlled trial to evaluate the effectiveness of $Hantavax^{TM}$ against HFRS in 3,900 healthy adults living in the endemic areas of Yugoslavia. 1,900 people were given 0.5 ml of Hantavax subcutaneously twice at one month interval and a booster shot at one year after. For controls other 2,000 healthy people were given 0.5 ml of physiolosical saline as a placebo. We investigated HFRS cases in both the vaccinated and nonvaccinated groups by monitoring the program for patient registration in the areas from 1996 to 1998, and the effect of vaccine was analyzed epidemiologically. No confirmed case of HFRS was observed among 1,900 Hantavax vaccinees, while 20 confirmed cases were observed among 2,000 nonvaccinated control group. There were no remarkable side effects among the vaccinees either locally or in general after inoculation of the vaccine. The Hantavax vaccine showed statistically significant protective efficacy against HFRS among Yugoslavian people.

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