• 제목/요약/키워드: Non-clinical trial

검색결과 247건 처리시간 0.033초

Non-randomized, one way cross-over, open label preliminary clinical trial for silk protein based oral gargling

  • Kang, Yei-Jin;Ahn, Se-Hui;Kim, Yong-Wan;Jo, You-Young;Kweon, HaeYong;Kim, Seong-Gon
    • International Journal of Industrial Entomology and Biomaterials
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    • 제38권1호
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    • pp.14-17
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    • 2019
  • Oral gargling solution has been used for the control of halitosis. The purpose of this study was to compare the level of hydrogen sulphide concentration between silk oral gargling solution and commercially available oral gargling solution. Total 21 volunteers were included in this study. The relative level of hydrogen sulphide concentration was calculated to the baseline level. In terms of the primary endpoint of the trial, relative level of hydrogen sulphide concentration was $50.84{\pm}33.19%$ with silk group, versus $71.07{\pm}21.83%$ with Listerine group ($P_{non-inferiority}=0.003$). In conclusion, the results of oral gargling with a silk protein for healthy individual were non-inferior to oral gargling with Listerine for hydrogen sulphide concentration reduction.

Chronic non-bacterial osteomyelitis in the jaw

  • Kim, Soung Min;Lee, Suk Keun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제45권2호
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    • pp.68-75
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    • 2019
  • Chronic recurrent multifocal osteomyelitis (CRMO) is one of the most severe form of chronic non-bacterial osteomyelitis (CNO), which could result in bone and related tissue damage. This autoinflammatory bone disorder (ABD) is very difficult for its clinical diagnosis because of no diagnostic criteria or biomarkers. CRMO in the jaw must be suspected in the differential diagnosis of chronic and recurrent bone pain in the jaw, and a bone biopsy should be considered in chronic and relapsing bone pain with swelling that is unresponsive to treatment. The early diagnosis of CRMO in the jaw will prevent unnecessary and prolonged antibiotic usage or unnecessary surgical intervention. The updated researches for the identification of genetic and molecular alterations in CNO/CRMO should be studied more for its correct pathophysiological causes and proper treatment guidelines. Although our trial consisted of reporting items from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), there are very few articles of randomized controlled trials. This article was summarized based on the author's diverse clinical experiences. This paper reviews the clinical presentation of CNO/CRMO with its own pathogenesis, epidemiology, recent research studies, and general medications. Treatment and monitoring of the jaw are essential for the clear diagnosis and management of CNO/CRMO patients in the field of dentistry and maxillofacial surgery.

소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 - (The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP-)

  • 정윤경;최서연;방미란;이보람;장규태
    • 대한한방소아과학회지
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    • 제38권1호
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

뇌혈관질환 후 실어증의 한의학적 치료에 대한 국내 임상연구에 대한 고찰 (Review of Clinical Research about the Treatment of Aphasia after Cerebrovascular Disease)

  • 고지윤;손아현;신현수
    • 대한한방내과학회지
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    • 제39권6호
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    • pp.1105-1115
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    • 2018
  • Objectives: The aim of this review is to investigate clinical studies on Oriental medicine treatment for aphasia after cerebrovascular disease. Methods: Using the keywords 'Aphasia', 'Oriental medicine', 'Stroke' 'Cerebral infarction', 'Cerebral hemorrhage', and 'Clinic', we searched domestic databases, including "NDSL (National Discovery for Science Leaders)", "Korean Traditional Knowledge Portal", "OASIS (Oriental Medicine Advanced Searching Integrated System)", and "RISS (Research Information Sharing Service)". Each keyword was not searched individually, but combined in various ways. To investigate recent trends, we limited our search to papers published after 2000. Papers that did not include a specific treatment method or did not match the subject "Aphasia after stroke" were excluded. Results: Using the searching method, 13 studies were found. Of these, 12 studies were in the form of case reports, while one was in the form of a non-randomized controlled trial. These studies showed positive results for the use of Oriental medicine in terms of the Korean version of the Western Aphasia Battery (K-WAB), the evaluation form on functional performance capability and accuracy of articulatory organs developed by Lee, aphasia screening test refered in 'Assessment in Speech-Language Pathology' and adapted properly to Korean, the Communicative Ability in Daily Living Test (CADLT), the Korean Version-Boston Naming Test (K-BNT), and language assessment items included in CNS, and NIHSS. Conclusions: Of the 12 case reports, 11 studies showed positive results of the use of Oriental medicine for treatment of aphasia after cerebrovascular disease. However, more sophisticated and large-scale clinical research on aphasia should be conducted.

Prospective Clinical Trial of Survival Rate for Two Different Implant Surfaces Using the Osstem(R) SS II Non-submerged Implant System in Partially Edentulous Patients

  • Kim, Su-Gwan;Lim, Chae-Su;Oh, Min-Seok;Park, Jin-Sung;Kim, Seo-Yoon;Seol, Ka-Young
    • Journal of Korean Dental Science
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    • 제2권2호
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    • pp.35-41
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    • 2009
  • Objective : This study sought to investigate the clinical survival rate of two implants with different surfaces: resorbable blasting media (RBM)-treated and calcium metaphosphate (CMP)-coated implant. Study design : SSII non-submerged implants (Osstem, Seoul, Korea) were placed in a total of 48 patients with mean age of 38.8. At least 31 patients in the experimental group had a CMP-coated implant, and 1 patient in the control group received a, RBM surface implant. The evaluation period was between April 2006 and December 2007. Radiographs, periotest, clinical periodontal examination, and prosthetic adjustment and occlusion were used. Results : The survival rate of the experimental and control groups after 1 year was 97.2% and 100%, respectively. The Wald confidence interval reported for the experimental group was not inferior to the control group. Conclusion : No significant differences were found between the RBM and CMP groups. The observed data suggest that CMP-coated methods can provide favorable clinical results for the functioning and healing of dental implants.

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이침 임상시험에서의 대조군에 대한 문헌고찰 (A literature review on controlling methods used in clinical trials of auricular acupuncture)

  • 이지영;임윤경
    • Korean Journal of Acupuncture
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    • 제25권2호
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    • pp.57-69
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    • 2008
  • Objectives : To review the controlling methods used in RCTs (randomized controlled trials) of auricular acupuncture. Methods : To investigate the controlling methods used in clinical trials of auricular acupuncture, 46 articles were retrieved from PUBMED (from August 1976 to August 2007, with limits: english, clinical trial) using the key words of "ear acupuncture", "auricular acupuncture", "auriculo-medicine", and sorted out according to the types of control treatments. Among them, 10 articles were selected based on STRICTA (Standards for Reporting Intervention in Controlled Trials of Acupuncture), and the controlling methods used in those articles were reviewed. Results : In clinical trials of auricular acupuncture, 'sham acupoints (non-acupoints and non-treatment acupoints included)', 'minimal acupuncture', 'pseudo-intervention', and 'placebo devices' have been used as controlling methods, but their 'inactivity' have been in question. To compensate the disadvantages of 'minimal acupuncture', and 'pseudo-intervention' control, placebo auricular acupuncture needles have been developed, although these needles didn't satisfy the conditions of 'blinding' and 'physical inactivity' simultaneously. Conclusions : Further researches on 'sham acupoints' and new development of 'placebo auricular acupuncture needles' are needed.

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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;

신체화 장애에 대한 중의학 연구동향 (A Review on Treatment of Somatization Disorder in Traditional Chinese Medicine)

  • 김효섭;배진수;이승환;임정화;성우용
    • 동의신경정신과학회지
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    • 제28권3호
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    • pp.217-230
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    • 2017
  • Objectives: This study was conducted to review studies on somatization disorder in traditional Chinese medicine. Methods: We reviewed studies in the China National Knowledge Infrastructure (CNKI) to 2017. Keywords were 軀體化障碍, Somatization disorder, somatic symptom disorder. We included Randomized Controlled Trial (RCT), and excluded non-Randomized Controlled Trial (nRCT), non-related somatization disorder or traditional Chinese medicine, non-clinical trials, dissertations for degrees. Jadad scale and Cochrane Library's Risk of Bias (RoB) were used for assessment of the quality of studies. Results: Twelve studies were selected. The Chinese Classification of Mental Disorders-3 (CCMD-3) was most frequently used as diagnostic criteria for somatization disorder. As for outcome measurement, Hamilton Rating Scale for Depression (HAMD) was used most commonly. Meta-analysis of 10 studies revealed effective rate of Chinese Herbal Medicine groups (CHM) was significantly higher than Western Medicine groups (WM) (RR: 1.14, 95% CI: 1.02 to 1.27, p=0.02, $I^2=40%$). There was no significant difference in effective rate of CHM+WM and WM (RR: 1.12, 95% CI: 0.84 to 1.49, p=0.46, $I^2=83%$). And also, effective rate of Acupuncture group (Acu) revealed no significant difference compared to that of WM (RR: 1.17, 95% CI: 0.95 to 1.44, p=0.13, $I^2=84%$). For HAMD, there was significant difference in CHM vs, WM group and Acu vs. WM group. Quality of selected 12 RCTs was low. Conclusions: Therapies practiced in traditional Chinese medicine may be effective options for somatization disorder. treatment. For further clinical studies in Korean medicine, this study could be groundwork for development of diagnosis and treatment on somatization disorder.

침 임상연구에 사용된 거짓침의 분석 (Review and Analysis of Sham Acupuncture in Acupuncture Clinical Trials)

  • 장진영;김소정;김남식;남상수;김용석
    • Journal of Acupuncture Research
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    • 제28권5호
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    • pp.29-38
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    • 2011
  • Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.

Chewing gum as a non-pharmacological alternative for orthodontic pain relief: A randomized clinical trial using an intention-to-treat analysis

  • da Silva Santos, Diego Junior;Capelli, Jonas Jr.
    • 대한치과교정학회지
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    • 제51권5호
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    • pp.346-354
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    • 2021
  • Objective: To compare the effectiveness of ibuprofen, acetaminophen, and chewing gum for orthodontic pain relief and to assess if chewing gum can be a non-pharmacological alternative for orthodontic pain relief. Methods: The study enrolled 106 patients of both sexes, aged ≥ 12 years, with body weight > 50 kg, and mild-to-moderate dental crowding in the upper arch. After randomization and allocation concealment, the intervention groups were either administered with ibuprofen (400 mg) or acetaminophen (500 mg) or chewed sugar-free chewing gum immediately after initial archwire placement and every 6 hours for 1 week if the pain persisted. The control group did not receive any pain relief. The pain was assessed on a 100-mm visual analog scale at rest and while biting down at T1 (2 hours), T2 (24 hours), T3 (2 days), T4 (3 days), T5 (7 days), and T6 (21 days). Statistical analyses were performed using the Kruskal-Wallis and post-hoc Mann-Whitney U tests (α = 0.05). Results: The chewing gum group experienced more pain relief than the ibuprofen group at while biting down at T3 (p = 0.04) and at rest at T4 (p < 0.001). The chewing gum group reported more pain relief than the acetaminophen and control groups while biting down at T3 (p = 0.03 and p = 0.0006, respectively) and T4 (both p < 0.001). Conclusions: Chewing gum can be a non-pharmacological alternative for orthodontic pain relief at 2 and 3 days after initial archwire placement.