• Title/Summary/Keyword: Trial registration

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

  • Kim, Hyungsuk;Jung, Jae-Young;Chung, Seok-Hee
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.4
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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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    • v.42
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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/

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.

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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    • v.45 no.5
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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;

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

  • An, Sung-Hu;Jeong, Yeong-jin;Kim, Jong-gyu;Shin, Hyeryung;Kwon, Young-Dal
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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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.

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

  • Lee, Yean-Ju
    • Korea journal of population studies
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    • v.31 no.2
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    • pp.77-100
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    • 2008
  • This study explores the implications of increasing cohabitation for the Korean family, by comparing the characteristics of cohabiters with those of married couples and of never-married and divorced people. Data are from the Marriage Registration Files for the years of 1997 through 2005 and Social Statistics Survey conducted in 2006. Results from descriptive statistics and logit analysis generally confirm the predictions of the western literature. First, cohabitation is part of overall changes in the family system. Cohabitation is more prevalent among the previously married than among the never married. Second, the socioeconomic status of cohabiting men is lower than that of married men. Third, according to spouses' employment status, educational levels, and age differences, gender roles are more egalitarian among cohabiting couples than among married couples. The finding that cohabiter characteristics are not similar to those of married couples seems to suggest that cohabitation does not simply represent a trial of marriage out of caution, unlike what most media articles assume. Instead, cohabitation may signify some unconventional circumstances forcing the couple to choose it as an alternative to marriage even temporarily. This and other conjectures discussed in this paper need to be reexamined with more rigorous data, as increasing trend of cohabitation seems to be inevitable in the coming years.

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

  • Park, Jong-Hyouk;Mamun, M.I.R.;El-Aty, A.M.Abd;Choi, Jeong-Heui;Im, Geon-Jae;Oh, Chang-Hwan;Shim, Jae-Han
    • The Korean Journal of Pesticide Science
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    • v.13 no.1
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    • pp.28-38
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    • 2009
  • An extrapolation of residue data of seven commonly used pesticides namely bifenthrin, chlorothalonil, cypermethrin, diazinon, fenvalerate, phenthoate and procymidone on a total of 22 minor crops has been carried out in an experimental field trial. The pesticides were applied to 11 leafy-, 5 root- and 6 stem-crops grown in the experimental green-house and the crops and plants were randomly collected at 1, 3, 5, 7 days after application. The average recoveries of applied pesticides were ranged from 72.0 to 117.0% in leafy crops, from 81.3 to 105.0% in stem crops and from 70.1 to 108.1% in the root-crops. Limits of detection (LODs) were 0.005-0.1 mg/kg in the leafy crops and 0.001-0.005 mg/kg in both the stem & root crops. Based on the results of residual dissipation pattern and their morphology, all crops were classified into high and low residual groups. The results showed that it might be possible to extrapolate residual data of stem-crops to root-crops within the same group. Crops that have currently no registered pesticide for use, would be possible to use the pesticides which are already been registered for the similar crops.

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
    • The Journal of Internal Korean Medicine
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    • v.41 no.3
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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
    • The Journal of Korean Medicine
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    • v.42 no.4
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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

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 ($1996{\sim}1998$년 유고슬라비아에서 실시한 한탄바이러스 불활화 백신($Hantavax^{TM}$)의 면역효과에 대한 야외시험)

  • Chu, Yong-Kyu;Gligic, Anna;Tomanovic, Snezana;Bozovjc, Boyana;Obradovic, Mirceta;Woo, Young-Dae;An, Chang-Nam;Kim, Hun;Jiang, Yang-Seok;Park, Seung-Chul;Kim, Min-Ja;Lee, Eun-Il;Lee, Ho-Wang
    • The Journal of Korean Society of Virology
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    • v.29 no.2
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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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