• Title/Summary/Keyword: randomized clinical trial

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EEG Changes due to Low-Frequency Electrical Stimulation to the BL62 and KI6 of Elderly Women (노년 여성의 신맥.조해 저주파 자극이 뇌파에 미치는 영향)

  • Lee, Sanghun;Choi, Kwang-Ho;Cho, Seong Jin;Choi, Sun-Mi;Hong, Kwon Eui;Ryu, Yeon-Hee
    • Korean Journal of Acupuncture
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    • v.30 no.2
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    • pp.135-142
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    • 2013
  • Objectives : This study aimed to investigate the general effects of low-frequency electrical stimulation of the ankle joint acupuncture points(BL62 and KI6) on the brain waves of elderly women as a pilot study to figure out the possibility of candidate non-invasive and non-chemical stimulation method for the enhancing the brain function. Methods : A randomized, controlled, double-blinded clinical trial was performed in 31 healthy women(mean age, 54.5 years) within a treatment duration of 12 sessions. In the experimental group, low-frequency electrical stimulation was applied using the maximum range of the individual insensible strength(mean current, $0.04{\mu}A$). The control group received sham stimulation. The background electroencephalographic activity was measured before and after the12 sessions. Results : After 12 sessions of stimulation, the relative power of the alpha wave increased(32 of 32 channels: significant difference in 11 channels, p<0.05); the theta(30 of 32 channels: significant difference in 10 channels, p<0.05), beta(31 of 32 channels), and gamma(30 of 32 channels: significant difference in 7 channels, p<0.05) powers were also decreased compared with the sham group. Conclusions : Electrical stimulation on the ankle joint acupuncture points(BL62 and KI6) seemed to stabilize the elderly women brain by inducing the alpha power and reducing beta, theta, and gamma powers. These results provide insight into the action mechanism of the stimulation and can assist the future developement of a non-invasive and non-chemical treatment technique for stressor related cognitive problems.

A Review of Domestic Research on Traditional Korean Medicine for Alcoholic Liver Disease (알코올성 간질환에 대한 한의학 연구 경향 분석 : 국내논문을 중심으로)

  • Cho, Na-kyung;Lee, Yu-ri;Kim, Kyung-soon;Choi, Hong-sik;Kim, Seung-mo;Back, Young-doo;Moon, Byung-kwon
    • The Journal of Internal Korean Medicine
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    • v.40 no.3
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    • pp.458-477
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    • 2019
  • Objectives: This study aimed to investigate the trend in the research on alcoholic liver disease (ALD) using Korean traditional medicine. Methods: This review was conducted using six electronic databases (NDSL, KMBASE, Koreantk, KISS, KISTI, and KoreaMed) with no restrictions in year. The search terms were "alcoholic liver disease", "alcoholic fatty liver", "alcoholic hepatitis", "alcoholic cirrhosis", "herbal medicine", "acupuncture" and "traditional medicine". The searched studies were analyzed according to the type of research. Results: After screening, 37 studies were selected among 552. The types of studies were as follows: 8 in vivo studies, 17 case reports, 7 case series, 1 assessment scale study, 1 randomized controlled trial, and 3 research reviews. The in vivo studies reported the efficacy and its mechanism in the animal phase of single or complex herbal medicine. In the clinical research, interventions such as herbal medicine and acupuncture were most commonly used for ALD treatment. Conclusions: We analyzed the trends in ALD treatment using Korean traditional medicine through this review. The results showed that Korean traditional medicine could be an effective method for ALD treatment. Conducting related in-depth studies, such as well-designed randomized controlled trial based on the results of experimental research, is necessary.

Superhongmi bran extract improves lipid profile and menopause symptoms: a randomized, placebo-controlled clinical trial (슈퍼홍미 미강 추출물의 폐경 후 여성의 혈중 지질 농도 및 대사성 질환 개선 효과)

  • Chung, Soo Im;Nam, Su Jin;Liang, Jie;Ma, Jing Wen;Kang, Mi Young
    • Korean Journal of Food Science and Technology
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    • v.51 no.2
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    • pp.182-187
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    • 2019
  • Women who undergo natural menopause transition have increased numbers of risk factors relating to metabolic syndrome due to estrogen deficiency. This study was conducted to investigate the effect of Superhongmi bran extract on metabolic syndrome improvement in menopausal women. Thirty women, who participated in a randomized, double-blind, placebo-controlled trial, were assigned to placebo-control (n=15) or Superhongmi bran extract (n=15) groups and were asked to consume two tablets (350 mg per extract per tablet) per day. After 12 weeks, weight, body mass index (BMI), plasma triglyceride (TG) levels, and total cholesterol (TC) levels were significantly decreased, whereas HDL-cholesterol (HDL-C), apolipoprotein A1 (ApoA1), adiponectin, superoxide dismutase 1 (SOD1), and GSH (glutathione) concentrations were significantly increased in the Superhongmi bran extract group. Moreover, $17{\beta}-estradiol$, and progesterone levels in the Superhongmi group were significantly higher than those in the placebo-control group. These results suggest that Superhongmi bran extract alleviates metabolic symptom in menopausal women.

The Effects of Ecklonia stolonifera Extracts on Improvement of Hepatic Function: a Double-Blind, Randomized, Placebo-Controlled Clinical Study (곰피추출물의 간기능 개선 효과 평가를 위한 12주, 무작위배정, 이중맹검, 위약-대조 인체적용시험)

  • Kim, Junghee;Kim, Eun Jin;Kang, Dahye;Kim, Hyung-Bin;Jang, Jae Young;Om, Ae-Son;Kim, Jongwook
    • Journal of Food Hygiene and Safety
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    • v.37 no.3
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    • pp.198-205
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    • 2022
  • Hepatic diseases are divided into two types: alcoholic and non-alcoholic. Non-alcoholic liver injury finally induces fatty liver and damages liver function. Many studies have demonstrated that Ecklonia stolonifera has antioxidative, anti-inflammatory, and hepatoprotective activities. We conducted a 12-week double-blind, placebo-controlled, randomized trial to examine the efficacy of E. stolonifera extracts (ESE) on biochemical markers of hepatic function. Sixty-five subjects with mild or moderate liver injuries were randomly allocated to receive either 420 mg/d of ESE or a placebo for 12 weeks. Fifty-five participants completed the trial. No significant adverse events were observed among the subjects during the study. The primary end points were changes in plasma levels of aspartate transaminase (AST), alanine transaminase (ALT), and γ-glutamyltransferase (γ-GT). The secondary end points were changes in lipid profile levels, including total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL). Compared with the baseline, AST and ALT levels decreased significantly in the ESE group compared to those in the placebo group (P<0.001). In addition, γ-GT levels in the ESE group were significantly lower than those in the placebo group (P=0.016). There were no differences in the TC, TG, HDL, and LDL levels between groups. In conclusion, ESE consumption for 12 weeks improved liver parameters in subjects with liver injury. Regular consumption of ESE could maintain liver health in individuals at risk of hepatic damage.

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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    • v.24 no.2
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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.

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 (흑효모배양액 분말의 면역관련 사이토카인에 미치는 영향에 대한 무작위 배정 임상연구)

  • Choi, Hae-Yun;Kim, Jong-Dae;Park, Mee-Yeon
    • Korean Journal of Oriental Medicine
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    • v.15 no.3
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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
    • The Journal of Korean Medicine
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    • v.43 no.2
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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.

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

  • Park, Sun-Ju;Go, Ho-Yeon;Han, Yoo-Jin;Ko, Seong-Gyu;Kim, Sung-Hoon
    • The Korea Journal of Herbology
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    • v.24 no.4
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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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    • v.1 no.2
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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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Effects of ASPAN's Evidence-based Clinical Practice Guidelines for Promotion of Hypothermia of Patients with Total Knee Replacement Arthroplasty (슬관절 전치환술 환자의 저체온 관리를 위한 ASPAN의 근거기반 임상실무 가이드라인 적용 효과)

  • Yoo, Je Bog;Park, Hyun Ju;Chae, Ji Yeoun;Lee, Eun Ju;Shin, Yoo Jung;Ko, Justin Sangwook;Kim, Nam Cho
    • Journal of Korean Academy of Nursing
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    • v.43 no.3
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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.