• 제목/요약/키워드: randomized clinical trial

검색결과 912건 처리시간 0.023초

Efficacy of sucrose application in minimizing pain perception related to dental injection in children aged 3 to 9 years: a randomized control trial

  • Ishani Ratnaparkhi;Jasmin Winnier;Divya Shetty;Sanjana R. Kodical;Reema Manoj;Shilpa S Naik
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제24권2호
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    • pp.109-117
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    • 2024
  • Background: Dental fear and anxiety are significant challenges in managing behavior in children. Oral administration of sucrose or sweet-tasting solutions has shown effectiveness in reducing procedural pain in infants and neonates. This study aimed to investigate whether pre-application of sucrose solution had an effect on minimizing pain perception during injection and to assess the potential impact of the child's age and sweet preference. Methods: A randomized control clinical trial was conducted on 60 children aged 3-9 years requiring buccal infiltration injections. Following parental consent, demographic data of the children were recorded. Sweet preferences was assessed using a modified forced-choice test. Children were equally and randomly allocated into study (sucrose) and control groups using a lottery method. Sucrose solution or distilled water, respectively, was applied to the lateral surface of the tongue for 2 min. Topical anesthetic was applied at the site of injection, followed by local anesthesia administration. The children rinsed their mouths thrice with water immediately after anesthetic injection. A video was recorded during injection which was then scored by three blinded examiners on the Sound Eye Motor (SEM) scale. The children also self-evaluated using Wong-Baker Faces Pain Rating Scale (WBFPS). Results: The mean SEM scores and WBFPS scores were analyzed using the Kruskall-Wallis test. The mean SEM score in the study group was 1.37 ± 0.61, compared to 3.17 ± 0.87 in the control group, showing a statistically significant difference (P < 0.001). Mean pain scores assessed by WBFPS in the study group were 0.60 ± 1.4, while in the control group, they were 6.27 ± 2.33, also showing a statistically significant difference (P < 0.001). Children with a sweet preference demonstrated a subjective reduction in pain perception. Conclusion: Application of sucrose before dental injections in children helps to minimize pain upon injection across all age groups.

흑효모배양액 분말의 면역관련 사이토카인에 미치는 영향에 대한 무작위 배정 임상연구 (A 4 week Randomized, Double-blind Human Trial to Compare the Efficacy and Safety of Aureobasidium pullulans Cultured Solution and Placebo on Improvement of Immune in Subjects)

  • 최해윤;김종대;박미연
    • 한국한의학연구원논문집
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    • 제15권3호
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    • pp.83-91
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    • 2009
  • $\beta$-glucan is a fiber-type complex sugar (polysaccharide) derived from the cell wall of baker's yeast, oat and barley fiber, and many medicinal mushrooms, such as maitake. The primary uses of $\beta$-glucan are to enhance the immune system, to lower blood cholesterol levels and to treat tumor. $\beta$-glucan has no systemic toxicity in mice, therefore it needed clinical trail to prove efficacy and safety for human. The subjects total 56 healty volunteers were divided into two groups including taken $\beta$-glucan tablet group and placebo group. Subjects were taken two tablets per oral for 4 weeks. They had agreed to take part in this experiment, and didn't take any other clinical trail products. After 4 weeks blood of subjects were checked. The check list are TNF-$\alpha$, INF-$\gamma$, IL-2, IL-4, total WBC, differential WBC, RBC, hemoglobin, platelet, MCV, MCH, MCHC, HCT, Na, K, Ca, Cl, AST, ALT, ALP, $\gamma$-GTP, total protein, triglyceride, total cholesterol, total bilirubin, albumin, uric acid, creatinine, BUN, pH, protein, glucose, ketone body, blood, bilirubin. We evaluated efficacy by cytokines that compare before and after taking. Collected data were analyzed as two sample t-test, chi-square test and ANOVA using SAS V.9.1.This study results are that in TNF-$\alpha$ of $1^{st}$ efficacy measurement item, all of two groups figure were increased significantly compare to before figure. In IL4 of $2^{nd}$ efficacy measurement item, experimental group figure were decreased significantly but placebo group figure were increased. The conclusions show that based on the above results, $\beta$-glucan has favorable effect to enhance immune system, especially IL4 results showed that it has effect to improve the allergic immune system.

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Effect of Bi-/Unilateral Masticatory Training on Memory and Concentration - Assessor-blind, Cross-over, Randomized Controlled Clinical Trial

  • Bae, Jun-hyeong;Kim, Hyungsuk;Kang, Do Young;Kim, Hyeji;Kim, Jongyeon;Kim, Koh-Woon;Cho, Jae-Heung;Song, Mi-yeon;Chung, Won-Seok
    • 대한한의학회지
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    • 제43권2호
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    • pp.61-74
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    • 2022
  • Objectives: This study aimed to explore the short-term effects of bilateral masticatory training using an intraoral device on memory and concentration, which is an advanced form of Gochi, compared to the unilateral form with gum. Methods: Thirty young healthy participants (age, 16-30 years) were screened and randomly assigned to one of two sequences in a crossover design. The participants assigned to sequence A (n=15) performed bilateral mastication using an intraoral device with a total of 300 taps, followed by unilateral mastication using gum with the same number of repetitions and frequency, separated by a 7-day washout period. A reverse order was used for sequence B. The primary and secondary outcomes were the digit span test result and the symbol digit modality test and the word list recall results, respectively, which were conducted before and after each intervention. Results: Symbol digit modality test scores increased by 12.03±8.33 with bilateral mastication, which was significantly higher than that obtained with chewing gum (5.17 points;95% confidence interval: 0.99, 9.34; p<0.05). Changes in the digit span test and word list recall scores were not significantly different between the two groups. In the digit span test forward, symbol digit modality test, and word list recall test, bilateral mastication was not inferior to unilateral mastication in improving memory and concentration. Conclusions: Bilateral masticatory exercises using an intraoral device are not inferior to unilateral mastication with gum for improving memory in healthy young individuals. Further research is needed to determine the efficacy of bilateral masticatory training on cognitive function.

항암제 유발 신경독성을 관리하는 한의학 및 보완대체요법들과 임상시험 현황 (The Present Clinical Studies of Oriental Medicine and CAM Therapies in Chemotherapy-induced Peripheral Neurotoxicity)

  • 박선주;고호연;한유진;고성규;김성훈
    • 대한본초학회지
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    • 제24권4호
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    • pp.205-213
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    • 2009
  • Objectives : Cancer incidence is increasing in all countries and chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapeutic agents have been a clinically serious problems. So far therapeutic options for CIPN patients are limited and no confirmed methods have yet been established for dealing with peripheral neuropathy. Therefore this review is to provide an evidence-based summary of oriental medicine and CAM (complementary and alternative medicine) neuroprotective and treatment therapies which have gone through clinical trials. Methods : An overview of the domestic and international papers of adult clinical trials relating management of only CIPN symptoms through 1990 to present were searched by electronic databases. Search key words were chemotherapy-induced neurotoxicity, chemotherapy-induced peripheral neuropathy, chemotherapy toxicity & herb, chemotherapy toxicity & acupuncture, chemotherapy toxicity & CAM. Only English and Korean written papers were reviewed. Total 25 papers were reviewed in this study, 18 papers were retrieved by electronic search. Results : Clinical studies of managing CIPN were rare, two acupuncture clinical studies and four herb medicinal studies were found. Rest of 19 papers were about other CAM clinical studies. Total 25 papers were analyzed, and all interventions were focused on their pain control efficacy. Other 24 trials of potential therapies except one proved to be effective for CIPN, however some described to be inadequate positive or sufficient negative. Conclusions : As most of the studies were pilot studies, interventions for the prevention and treatment of CIPN have to go through prospective confirmatory studies, such as larger scale randomized, double-blinded, placebo controlled clinical trials must be done for the safe and effective use of proposed therapies. Also standard measurement scales have to be developed for the better clinical study of CIPN.

A review of atopic dermatitis in traditional Chinese medicine

  • Lee, Sang-Chang;Lee, Young-Seob;Seong, Man-Jun;Choi, Mi-Sun;Kang, Suk-Hoon;Lee, Sheng-Ho;Kim, Jong-Hak;Kim, Min-San;Kwon, Dong-Yeul
    • Journal of Evidence-Based Herbal Medicine
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    • 제1권2호
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    • pp.35-43
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    • 2008
  • Herbal medicines have an accurate effect on atopic dermatitis, and at the same time, they hardly have adverse reactions. However, herbal medicines are difficult to be quantitatively analyzed due to low-quality preparation and types. In addition, herbal medicines have raised many problems as they have not been standardized and their active components have not been analyzed. Patients with atopic dermatitis began to recognize the effectivity and safety of herbal medicines. Accordingly, standardization, biological analyses, animal experiments and clinical trials should be generally performed in order that herbal medicines may be recognized all over the world. A standard, which is to objectively judge the curative effect of atopic dermatitis, should be established as soon as possible. Case studies and RCTs (Randomized Controlled Trials) should be actively performed on the basis of rigid clinical trial design to the end that the curative effect of herbal medicines is recognized all the world over.

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슬관절 전치환술 환자의 저체온 관리를 위한 ASPAN의 근거기반 임상실무 가이드라인 적용 효과 (Effects of ASPAN's Evidence-based Clinical Practice Guidelines for Promotion of Hypothermia of Patients with Total Knee Replacement Arthroplasty)

  • 유제복;박현주;채지연;이은주;신유정;고저스틴상욱;김남초
    • 대한간호학회지
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    • 제43권3호
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    • pp.352-360
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    • 2013
  • Purpose: In this study an examination was done of the effects of the American Society of PeriAnesthesia Nurses (ASPAN) Evidence-Based Clinical Practice Guidelines on body temperature, shivering, thermal discomfort, and time to achieve normothermia in patients undergoing total knee replacement arthroplasty (TKRA) under spinal anesthesia. Methods: This study was an experimental study with a randomized controlled trial design. Participants (n=60) were patients who underwent TKRA between December 2011 and March 2012. Experimental group (n=30) received active and passive warming measures as described in the ASPAN's guidelines. Control group (n=30) received traditional care. Body temperature, shivering, thermal discomfort, time to achieve normothermia were measured in both groups at 30 minute intervals. Results: Experimental group had slightly higher body temperature compared to control group (p=.002). Thermal discomfort was higher in the experimental group before surgery but higher in the control group after surgery (p=.034). It decreased after surgery (p=.041) in both groups. Time to achieve normothermia was shorter in the experimental group (p=.010). Conclusion: ASPAN's guidelines provide guidance on measuring patient body temperature at regular intervals and on individualized and differentiated hypothermia management which can be very useful in nursing care, particularly in protecting patient safety and improving quality of nursing.

Effects of Copper Reduction on Angiogenesis-Related Factors in Recurrent Glioblastoma Cases

  • Jazayeri, Shima;Feli, Alireza;Bitaraf, Mohammad Ali;Dodaran, Masoud Solaymani;Alikhani, Mazdak;Hosseinzadeh-Attar, Mohammad Javad
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권10호
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    • pp.4609-4614
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    • 2016
  • Purpose: To evaluate the therapeutic effects of copper reduction on angiogenesis-related factors in patients with glioblastoma multiforme treated by gamma knife radiosurgery. Materials and Methods: In the present block randomized, placebo-controlled trial, fifty eligible patients with a diagnosis of glioblastoma multiforme who were candidates for gamma knife radiosurgery were randomly assigned into two groups to receive daily either 1gr penicillamine and a low copper diet or placebo for three months. The intervention started on the same day as gamma knife radiosurgery. Serum interleukin-6 (IL-6), tumor necrosis $factor-{\alpha}$ ($TNF-{\alpha}$), vascular endothelial growth factor (VEGF) and copper levels were measured at baseline and after the intervention. The serum copper level was used as the final index of compliance with the diet. In order to control probable side effects of intervention, laboratory tests were conducted at the beginning, middle and end of the study. Results: The patients had a mean age and Karnofsky Performance Scale of 43.7 years and 75 respectively. Mean serum copper levels were significantly reduced in intervention group. Mean survival time was 18.5 months in intervention group vs. 14.9 in placebo group. VEGF and IL-6 levels in the intervention group were also significantly reduced compared to the placebo group and $TNF-{\alpha}$ increased less. Conclusions: It seems that reducing the level of copper in the diet and dosing with penicillamine leads to decline of angiogenesis-related factors such as VEGF, IL-6 and $TNF-{\alpha}$. Approaches targeting angiogenesis may improve survival and can be used as a future therapeutic strategy.

홍삼의 온열 효과와 복약 순응도에 관한 연구 (A Study on Thermal Effect and Medication Compliance of Red Ginseng Extract)

  • 최민선;정재철;박장경;안홍엽;김동일
    • 대한한방체열의학회지
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    • 제7권1호
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    • pp.44-54
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    • 2009
  • Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.

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Serum level changes of long chain-polyunsaturated fatty acids in patients undergoing periodontal therapy combined with one year of omega-3 supplementation: a pilot randomized clinical trial

  • Martinez, Gisele Lago;Koury, Josely Correa;Martins, Marcela Anjos;Nogueira, Fernanda;Fischer, Ricardo Guimaraes;Gustafsson, Anders;Figueredo, Carlos Marcelo S.
    • Journal of Periodontal and Implant Science
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    • 제44권4호
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    • pp.169-177
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    • 2014
  • Purpose: We aimed to investigate the impact of nonsurgical periodontal treatment combined with one-year dietary supplementation with omega (${\omega}$)-3 on the serum levels of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and arachidonic acid (AA). Methods: Fifteen patients with chronic generalized periodontitis were treated with scaling and root planing. The test group consisted of seven patients ($43.1{\pm}6.0$ years) supplemented with ${\omega}$-3, consisting of EPA plus DHA, three capsules, each of 300 mg of ${\omega}$-3 (180-mg EPA/120-mg DHA), for 12 months. The control group was composed of eight patients ($46.1{\pm}11.6$ years) that took a placebo capsule for 12 months. The periodontal examination and the serum levels of DPA, EPA, DHA, and AA were performed at baseline (T0), and 4 (T1), and 12 (T2) months after therapy. Results: In the test group, AA and DPA levels had been reduced significantly at T1 (P<0.05). AA and EPA levels had been increased significantly at T2 (P<0.05). The ${\Delta}EPA$ was significantly higher in the test compared to the placebo group at T2-T0 (P=0.02). The AA/EPA had decreased significantly at T1 and T2 relative to baseline (P<0.05). Conclusions: Nonsurgical periodontal treatment combined with ${\omega}$-3 supplementation significantly increased the EPA levels and decreased the AA/EPA ratio in serum after one year follow-up. However, no effect on the clinical outcome of periodontal therapy was observed.

균형과 보행능력 향상을 위한 오타고 운동프로그램의 임상적 유용성: 만성 뇌졸중 환자를 대상으로, 무작위 배정 실험연구 (Clinical Feasibility of Otago Exercise Program to Improve the Balance and Gait Ability: In Chronic Stroke Patient, Randomized Controlled Trial)

  • 송현승;윤태원
    • 대한물리의학회지
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    • 제11권2호
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    • pp.63-70
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    • 2016
  • PURPOSE: The aim of this study was to conduct an Otago exercise program with stroke patients in a clinical setting and ascertain its effects on balance and walking ability. METHODS: The participating subjects were 45 people who had been diagnosed with stroke. They were assigned to two groups (Otago exercise; OE, n=22; balance exercise; BE, n=23), and the exercises were conducted for three sessions per week for eight weeks. The main balance outcomes were evaluated using the timed up and go test (TUG) and the four step square test (FSST), while walking ability was evaluated using the 10 m walk test (10MWT), direction change ability was measured using the figure 8 of walk test (F8WT), and the decrease of fear was evaluated using the modified falls efficacy scale (MFES). RESULTS: In the analysis results, the Otago exercise group showed significant increases in TUG, FSST, 10MWT, and F8WT within the both groups. There were significant differences in all variables between the OE group and the BE group at the post-intervention evaluation, but there was no significant difference between the groups with respect to the 10MWT. This study showed that conducting Otago exercise in stroke patients increased the main outcomes for TUG, FSST, F8WT scores, but not for 10MWT. CONCLUSION: The results of this study demonstrated that Otago exercise would be useful to improve balance and gait for stroke patients who want to improve their abilities and activities of daily living.