• Title/Summary/Keyword: randomized clinical trial

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Effects of multiple herb formula SEC-22 supplementation on dietary intake, picky eating behaviors, and growth indices in thin preschool children

  • Kim, Kijoon;Lee, Joonsuk;Paik, Hee Young;Yoon, Jihyun;Ryu, Bongha;Shim, Jae Eun
    • Nutrition Research and Practice
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    • v.9 no.4
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    • pp.393-399
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    • 2015
  • BACKGROUND/OBJECTIVES: Thin children may have insufficient intake of energy and nutrients, resulting in reduced immune function and growth. This study aimed to identify the effects of multiple herb formula SEC-22 supplementation on growth, dietary changes, and picky eating behaviors in thin children. SUBJECTS/METHODS: A double-blind, randomized clinical trial was conducted on 79 children aged 2-5 years with poor appetites, BMI percentile < 25, and without any illness. Subjects were given either SEC-22 (n = 35) or placebo (n = 44) for 2 months and followed for an additional 2 months. Three-day dietary records, questionnaires on picky eating behaviors, and anthropometric measures were collected. RESULTS: Energy, carbohydrate intake, and feeding difficulty improved in both groups during the intervention period. However, changes were maintained only in the SEC-22 group after 2 months of follow-up post-supplementation. 'Frequency of trying to feed' was improved in the SEC-22 group compared to the placebo group after the first month of follow-up (P < 0.05). Intakes of potassium and thiamine were improved in the SEC-22 group compared to the placebo group after the first month of intervention (P < 0.05). 'Frequency of food reward', eating amount, and intakes of carbohydrate, potassium, and vitamin C showed significant improvement compared to the placebo group after the second month of follow-up (P < 0.05). CONCLUSIONS: These results suggest that SEC-22 supplementation can improve parental feeding difficulty resulting from insufficient eating amount or picky eating as well as increase nutrient intake in thin children. Although these improvements were observable at least 2 months after supplementation, effects beyond this time frame need to be confirmed.

Neuroprotective Effects of Lacosamide in Experimental Peripheral Nerve Injury in Rats : A Prospective Randomized and Placebo-Controlled Trial

  • Demiroz, Serdar;Ur, Koray;Bengu, Aydin Sukru;Ulucan, Aykut;Atici, Yunus;Erdogan, Sinan;Cirakli, Alper;Erdem, Sevki
    • Journal of Korean Neurosurgical Society
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    • v.63 no.2
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    • pp.171-177
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    • 2020
  • Objective : To evaluate the neuroprotective effects of lacosamide after experimental peripheral nerve injury in rats. Methods : A total of 28 male wistar albino rats weighing 300-350 g were divided into four groups. In group I, the sciatic nerve exposed and the surgical wound was closed without injury; in group II, peripheral nerve injuries (PNI) was performed after dissection of the nerve; in group III, PNI was performed after dissection and lacosamide was administered, and in group IV, PNI was performed after dissection and physiological saline solution was administered. At 7 days after the injury all animals were sacrificed after walking track analysis. A 5 mL blood sample was drawn for biochemical analysis, and sciatic nerve tissues were removed for histopathological examination. Results : There is low tissue damage in lacosamide treated group and antioxidant anzymes and malondialdehyde levels were higher than non-treated and placebo treated group. However there was no improvement on clinical assessment. Conclusıon : The biochemical and histological analyses revealed that lacosamide has neuroprotective effect in PNI in rats. This neuroprotective capacity depends on its scavenger role for free oxygen radicals by increasing antioxidant enzyme activity.

Effects of AIF on Knee Osteoarthritis Patients: Double-blind, Randomized Placebo-controlled Study

  • Park, Sung-Hoon;Kim, Seong-Kyu;Shin, Im-Hee;Kim, Hyung-Gun;Choe, Jung-Yoon
    • The Korean Journal of Physiology and Pharmacology
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    • v.13 no.1
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    • pp.33-37
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    • 2009
  • Anti-inflammatory factor(AIF) is a water soluble extract of three herbs, Panax notoginseng(Burk.) F. H. Chen, Rehmannia glutinosa Libosch and Eleutherococcus senticosus. The present study aimed to investigate the safety and efficacy of herb extracts, AIF, on Korean knee osteoarthritis patients for six weeks. Fifty seven patients with knee osteoarthritis, ranging from 43 to 73 years of age, who fulfilled the "American College of Rheumatology"(ACR) classification of idiopathic osteoarthritis of knee and radiographic criteria were randomly selected and enrolled for the study. After initial screening and resting period, two capsules each of AIF(Each capsule contains; 400 mg) and similar identical placebo were administered twice a day to both groups. Pain intensity at second, fourth, and sixth weeks of study as well as one week after discontinuation of drugs was assessed by using 100 mm visual analogue scale(VAS). Changes in the Korean version of the Western Ontario and McMaster Universities(K-WOMAC) index score were compared at the initiation and completion of the study. VAS assessed by patients were significantly reduced(at visit 2; $54.64{\pm}14.72$, at visit 4, $37.32{\pm}16.58$, p<0.001) after AIF administration. Results showed an improvement in the physical function of K-WOMAC scale which was significantly higher(p=0.013) in AIF than placebo group, and decreases of total K-WOMAC score were also significantly higher(p=0.030) in AIF groups than placebo group. No serious adverse effect was observed, and there was no difference in incidence of adverse effect between AIF and placebo groups. In this population of Korean patients with knee osteoarthritis, AIF was found to be safe, tolerable and effective for symptomatic improvement of pain and physical function.

A Preliminary Study of the Effects of Monitor-Based Virtual Reality Games on the Cognition & Activities of Daily Living for Acute Stroke : A Double-blind Randomized Controled Trial (모니터기반 가상현실게임을 이용한 중재가 급성기 뇌졸중 환자의 인지 기능과 일상생활활동에 미치는 영향에 대한 사전연구: 이중 맹검 무작위 대조 시험 연구)

  • Choi, Bong-Geun;Kwon, Jae-Sung
    • The Journal of the Korea Contents Association
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    • v.20 no.9
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    • pp.531-540
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    • 2020
  • Objectives: This study aimed to investigate the effects of a 4-weeks intervention using a monitor-based virtual reality game intervention(VRI) on the cognitive function and activities of daily living of individuals with acute stroke. Methods: For this study, 19 individuals with acute stroke were recruited. To compare the effectiveness of the VRI and the computer based cognitive intervention(CBCI), Each of the two groups were provided different interventions a 30 minutes a day, 5 times per week for 4 weeks, and to measure the effects of the intervention, the TMT A&B, DST, RKMT and K-MBI were performed before and after interventions. Results: Both the VRI and the CBCI were found to have significantly improved the cognitive function and activities of daily living, and the difference in change compared between groups showed that the effectiveness of the VRI was significantly higher. Conclusion: Based on the findings of this study, the monitor-based VRI is anticipated to prove useful as an effective intervention for the cognitive function and activities of daily living of stroke patients. Furthermore, the utility of monitor-based VRI is likely to be high in clinical occupational therapy.

The Effects of Communication Training Applying Gagné's Nine Events of Instruction and Video Clips upon Communication Competency and Interpersonal Relations in Nursing Students (가네의 9가지 수업사태와 비디오 클립을 적용한 의사소통 훈련이 간호대학생의 의사소통 능력과 대인관계에 미치는 효과)

  • Cha, Jin-Gyung;Kim, Hyang-Ha
    • Journal of East-West Nursing Research
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    • v.23 no.2
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    • pp.115-123
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    • 2017
  • Purpose: The purpose of this study was to determine the effects of teaching communication training using $Gagn{\acute{e}}^{\prime}s$ 9 events of instruction and video clip on communication competency and interpersonal relations of nursing students. Methods: The participants were 79 nursing students (41 in the intervention group, 38 in the control group). A nonequivalent control group design was used. The research was carried out from September 7 to November 20, 2015. Teaching communication skills using $Gagn{\acute{e}}^{\prime}s$ 9 events of instruction and video clip were provided to the intervention group 180 minutes/session once a week for 9 weeks. Data were analyzed using chi-square test, independent t-test and ANCOVA with SPSS/PC version 21.0. Results: The intervention group reported significantly higher scores of communication competency(F=8.41, p=.005) and interpersonal relations(F=8.97 p=.004) compared to those of the control group at the completion of the intervention. Conclusion: The findings of this study show that $Gagn{\acute{e}}^{\prime}s$ 9 events of instruction and video clip is an effective communication training for improving communication competency and interpersonal relations in nursing students. A randomized clinical trial is needed to confirm the value of communication training using $Gagn{\acute{e}}^{\prime}s$ 9 events of instruction and video clip for nursing students.

Effects of Jetongdan on the Quality of Life in Patients with Osteoarthritis of Knee (제통단이 퇴행성 슬관절염 환자의 삶의 질에 미치는 영향)

  • Seo, Byung-Kwan;Ryu, Seong-Ryong;Kang, Jung-Won;Woo, Hyun-Su;Lee, Jae-Dong;Choi, Do-Young;Kim, Keon-Sik;Lee, Doo-Ik;Lee, Yun-Ho;Lee, Sang-Hoon
    • Journal of Acupuncture Research
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    • v.22 no.6
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    • pp.219-228
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    • 2005
  • Objectives : to evaluate the effects of Jetongdan, the newly developed herbal medicine, on the quality of life in patients with osteoarthritis of knee Methods : Placebo-controlled, randomized clinical trial on the 80 patients with osteoarthritis of the knee was fulfilled. After enrollment, they took medication as they enrolled. And they were asked to answer the questionnaires (Korean Health Assessment Questionnaire (KHAQ), Lequesne's functional index (LFI), visual analogue scale (VAS)) and analysed with the erythrocyte sedimentation rate (ESR) at baseline, after 4 weeks and 8 weeks of medication. Results : Total KHAQ score, some categories of KHAQ like hygiene, activities were significantly improved after 8 weeks of medication. And the change of the KHAQ score was significantly correlated with the change of VAS. But LFI, VAS, ESR level was not significantly improved, and it was considered because of the short medication period and small size of study population. Conclusion : In conclusion, Jetongdan could improve the health-related quality of life in patients with osteoarthritis of knee. Further study in the large population, in long period were recommended.

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Effects on Labor Pain, Length of Delivery Time, and Hemoglobin of Primipara Women treated by San-Yin-Jiao(SP-6) Acupressure 15 minutes and 30 minutes (삼음교(SP6) 지압(15분/30분)이 분만 통증, 분만 소요시간, Hemoglobin에 미치는 영향)

  • Chang, Soon-bok;Park, Young-won;Cho, Jae-sung;Lee, Byung-chul
    • Journal of Acupuncture Research
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    • v.21 no.1
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    • pp.99-110
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    • 2004
  • Objective: The purpose of this study was to examine the different effects on labor pain, length of delivery time, and hemoglobin for primipara women treated by San-Yin-Jiao(SP-6) acupressure of 15 minutes or 30 minutes. Methods: The design of this study was a randomized clinical trial with two experimental groups and one control group, the participants included primiparas who underwent vaginal delivery. Data were collected using a structured questionnaire consisting of general characteristics with a subjective labor pain scale with VA.S, and length of delivery time and hemoglobin were collected in the medical record. Data was analyzed using descriptive statistics, x2- test, t-test, and ANCOVA. Results: There was statistically significant lower labor pain in the group of 30 minutes SP6 acupressure than the control group(t=7.733, p=.007), and there was statistically significant short length of delivery time in the group of 15 minutes SP6 acupressure than the control group(t=-2.230, p=.030). Conclusions: Even though we could not found a consistent effect with the SP6 acupressure, It was found that there was effect on shortening length of delivery time by 15 minutes of SP6 acupressure or lessening labor pain by 30 minutes of SP6 acupressure without risk of blood loss. It is necessary to replicate the study with a larger number of participants to find a consistent result.

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Acupotomy for Scapulohumeral Periarthritis

  • Guo, Chang Qing;Ma, Shi Ning;Fu, Xin Yi;Wang, Quan Gui;Lee, Mira
    • Journal of Acupuncture Research
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    • v.37 no.4
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    • pp.254-258
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    • 2020
  • Background: Scapulohumeral periarthritis causes pain and stiffness, and limits movement but it is a treatable condition. This was a clinical study of acupotomy treatment for scapulohumeral periarthritis. Methods: There were 80 patients randomly assigned to the traditional Chinese Medicine group (acupotomy) and the Western medicine group (naproxen), with 40 cases in each group. All patients had adjunct physiotherapy exercises for 14 days. Patients received acupotomy treatment 3 times for 14 days (Day 0, 7 and 14) or naproxen (0.22 g capsule; a non-steroidal anti-inflammatory drug) 3 times a day, for 14 days. The visual analogue scale (VAS) scores, range of motion (ROM) values, and the Melle scale, together with the therapeutic standard of diseases and syndromes in traditional Chinese Medicine were used for diagnosis and evaluation. Results: There were significant differences in the VAS scores, ROM, Melle scores, cure rate and total effective rate in the group which took naproxen and the acupotomy group, before and after treatment (p < 0.01). There were significant differences in the changes in VAS, ROM and Melle scores between the 2 groups (p < 0.01), and the acupotomy group was better than the naproxen group. Conclusion: Traditional Chinese Medicine and Western medicine can improve functional activity and reduce the level of pain experienced by patients suffering from scapulohumeral periarthritis. However, improvement of functional activity of the shoulder joint following acupotomy treatment was more obvious than the use of a non-steroidal anti-inflammatory drug, and the cure rate, and total effective rate of acupotomy was better.

Effect of Ginger and Chamomile on Nausea and Vomiting Caused by Chemotherapy in Iranian Women with Breast Cancer

  • Sanaati, Fateme;Najafi, Safa;Kashaninia, Zahra;Sadeghi, Masoud
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.8
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    • pp.4125-4129
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    • 2016
  • Background: Chemotherapy-induced nausea and vomiting (CINV) places a significant burden on the patient. Herbal agents are the most commonly complementary therapies used among the public. This study was done to determine the effect of ginger and chamomile capsules on nausea and vomiting in cases undergoing chemotherapy for breast cancer (BC). Materials and Methods: In a randomized, double-blind and clinical trial study, 65 women with BC undergoing chemotherapy were referred to Breast Cancer Research Center, Tehran, Iran, between May 2013 to June 2014. Regimen for ginger group for 5 days before and 5 days after chemotherapy was: 2 times a day and 500 mg capsules of powdered ginger root in addition to a routine antiemetic regimen consisting of dexamethasone, metoclopramide and aprepitant (DMA) capsules. Chamomile group similarly was: 2 times a day and 500 mg capsules of Matricaria chamomilla extract in addition to a routine antiemetic regimen consisting of DMA capsules. Control group, routine antiemetic regimen consisting of DMA capsules. Results: There were no significant differences between the ginger, chamomile and control groups regarding age. Drugs used for chemotherapy were identical and duration of disease was also matched (1-4 months). Ginger and chamomile were both significantly effective for reducing the frequency of vomiting, there being no significant difference between the ginger and chamomile groups. Moreover, unlike the chamomile, ginger significantly influenced the frequency of nausea. Conclusions: According to the findings of this study, it should be declared that taking ginger capsules (1 g/day) might relieve CINV safely. Nurses dealing directly with cancer patients should be responsible for providing educational programs for patients and their families about how to deal with their drug regimens and associated side effects.

Extracorporeal Life Support in Treatment of Poisoning Patient: Systematic Review (체외 생명유지술을 이용한 중독 환자의 치료: 체계적 고찰)

  • Lee, Yong Hee;Ko, Dong Ryul;Kong, Taeyoung;Joo, Young Seon;You, Je Sung;Chung, Sung Phil
    • Journal of The Korean Society of Clinical Toxicology
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    • v.14 no.1
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    • pp.1-8
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    • 2016
  • Purpose: Extracorporeal life support (ECLS) is a term used to describe a number of modalities including extracorporeal membrane oxygenation (ECMO) to support cardiac and/or pulmonary systems. The purpose of this study is to review the available evidence regarding the effect of ECLS in patients with acute poisoning. Methods: Electronic literature searches with PubMed, Embase, Cochrane library, and KoreaMed were conducted for identification of relevant studies addressing ECLS in treatment of acute poisoning. The literature search was conducted by two investigators in March, 2016 with publication language restricted to English and Korean. The toxic substance, technique of ECLS, and final outcome of each case were analyzed. Results: The final analysis included 64 articles including 55 case reports. There were no articles classified according to a high level of evidence such as randomized trial and prospective cohort study. ECLS treatment was used in the management of patients poisoned with 36 unique substances. Venovenous ECMO was performed in 4 cases. Among the reported cases, 10 patients died despite treatment with ECLS. Conclusion: Evidence supporting ECLS for patients with acute poisoning is inadequate. However, many case reports suggest that early consideration of ECLS in poisoned patients with refractory cardiac arrest or hemodynamic compromise refractory to standard therapies may be beneficial.

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