• 제목/요약/키워드: Intervention trial

검색결과 551건 처리시간 0.026초

발효굴추출물의 경구 섭취가 소아 신장 성장에 미치는 효과 및 안전성 평가를 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜 (Randomized, Double-blind, and Placebo-controlled a Human Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract: Study Protocol)

  • 김희연;박범찬;천진홍;최준용;안병민;박정현;이배진;김기봉
    • 대한한방소아과학회지
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    • 제33권4호
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    • pp.37-46
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    • 2019
  • Objectives The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature. Methods A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH. Results This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019. Conclusions This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature.

[ $\b{S}afety\;\b{A}nd\;\b{E}fficacy$ ] of $\b{K}orean$ red ginseng Intervention (SAEKI) Trial: Rationale, Design, and Expected Findings

  • Sievenpiper John L;Buono Marco Di;Stavro P. Mark;Jenkins Alexandra L;Nam Ki Yeul;Choi Melody;Naeem Asima;Leiter Lawrence A;Sung Mi-Kyung;Vuksan Vladimir
    • 고려인삼학회:학술대회논문집
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    • 고려인삼학회 2002년도 학술대회지
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    • pp.424-455
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    • 2002
  • Diabetes mellitus is reaching epidemic proportions worldwide. The insufficiency of medication to cope with this burden has coincided with a dramatic rise in the prevalence of use of complementary and alternative therapies, especially herbal treatments. This surge in demand presents a challenge to prove the safety and efficacy of these treatments in diabetes. Korean red ginseng (steam treated Panax ginseng C.A. Meyer) is a strong candidate to succeed. It has been shown to possess a multitude of hypoglycemic effects and improve metabolic disturbances related to diabetes in in vitro and animal models. Data in humans is also emerging to support these benefits. Whether these results can be replicated in a rigorous clinical testing program is unclear. We therefore investigated the antidiabetic effects of Korean red ginseng in a series of 2 acute and 1 longterm randomized, double-blinded, placebo-controlled clinical trials. This paper provides the rationale for this program of study, expanding on the problem of diabetes, its management, and the possible role for Korean red ginseng. It then describes the design and expected findings.

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Reliability and validity of the patellofemoral disability index as a measure of functional performance and subjective pain in subjects with patellofemoral pain syndrome

  • Alshaharani, Mastour Saeed;Lohman, Everett Bernell;Bahjri, Khaled;Harp, Travis;Alameri, Mansoor;Daher, Noha S.
    • Physical Therapy Rehabilitation Science
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    • 제7권2호
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    • pp.61-66
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    • 2018
  • Objective: Patellofemoral pain syndrome (PFPS) is a condition that is characterized by patellar discomfort or pain that is aggravated during certain activities such as ascending/descending stairs. The Patellofemoral Disability Index (PDI) was developed to assess the effect of pain on functional activities in individuals with PFPS. The objectives of the current study were to determine the internal consistency, test-retest reliability, and validity of this index. Design: Cross-sectional study. Methods: Forty-one subjects who had PFPS with a mean age of $28.8{\pm}5.0years$ and a mean body mass index of $25.6{\pm}4.7kg/m^2$ participated in the study. All subjects were concurrently enrolled in a clinical trial for which they were instructed to complete hamstring-resistance exercises for 4 weeks. Over the course of the intervention, they completed both the PDI and the Oswestry Disability Index (ODI) at baseline after two weeks, and after four weeks. Pearson correlation coefficient was used to assess the criterion validity. Cronbach's ${\alpha}$ was used to examine the internal consistency. Intraclass correlation coefficients with 95% confidence interval were computed to examine test-retest reliability. Results: Subjects' responses within both the PDI and the ODI yielded Pearson correlation coefficient values that were positive and highly significant (range, 0.73-0.97; p<0.001). There was a high level of internal consistency (Cronbach's ${\alpha}{\geq}0.8$), with the exception of stair climbing (Cronbach's ${\alpha}=0.65$). Intraclass correlation ranged from 0.87 to 0.92, indicating high levels of test-retest reliability. Conclusions: The PDI is a valid, reliable, and feasible method of assessing pain and functional ability in patients with PFPS.

아로마 손 마사지가 입원한 암 환자의 불안과 수면에 미치는 효과 (The Effects of Aroma Hand Massage on Anxiety and Sleep in Cancer Patients during Hospitalization)

  • 이은;김금순
    • Perspectives in Nursing Science
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    • 제8권1호
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    • pp.42-53
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    • 2011
  • Purpose: This study was conducted to investigate the effects of aroma hand massage on anxiety and sleep in cancer patients during hospitalization. Methods: This study used a pre-post non-synchronized quasi-experimental design. Data were collected from 66 participating patients from July to December 2008. The participants were divided into an aroma massage group (n=25), a hand massage group (n=15), and a control group (n=26). The experimental group received aroma hand massage using 1% diluted lavender aroma oil once per day for 3 days. The massage was given by the researcher following the Korea Aromatherapy Health Professional Association massage protocol In contrast control group A received only a hand massage. The state anxiety, sleep condition, sleep satisfaction levels, and sleep duration were measured before and after the intervention trial. Results: The aroma hand massage group experienced in a significant decrease in their state anxiety (F=7.658 p=.001). Moreover, there was a significant increase in their sleep condition (F=18.047, p=.001), sleep satisfaction (F=30.016, p=.001) and sleep duration (F=23.019, p=.001) compared to the other groups according to one-way ANOVA and Scheffe's multiple comparison test. Also, noted was a significant increase in the sleep condition of the hand massage group as in the aroma hand massage group according to the Scheffe test. Conclusion: The study findings indicates that aroma hand massage decreases anxiety and increases the sleep condition, sleep satisfaction, and sleep duration of cancer patients.

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고유수용성신경근촉진법 이완기법이 뒤넙다리근 유연성과 점프수행력에 미치는 영향 (Effects of Proprioceptive Neuromuscular Facilitation Relaxation Techniques on Hamstring Flexibility and Vertical Jump Performance)

  • 임재헌;이민국;박종혁;정태호;조은비
    • PNF and Movement
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    • 제13권3호
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    • pp.135-143
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    • 2015
  • Purpose: The purpose of this study was to assess the effect of the proprioceptive neuromuscular facilitation (PNF) relaxation technique (hold relax; HR, contract relax; CR) and static stretch (SS) on hamstring flexibility and vertical jump performance in healthy adults over a four-week period. Methods: Twenty-four healthy adults volunteered to participate in PNF and static stretch sessions. The subjects were divided into three groups as follows: 8 subjects in the SS group, 8 subjects in the HR group, and 8 subjects in the CR group. In the HR and CR groups, contractions lasted 15 seconds per trial and consisted of 5 sets of 15 seconds of hamstring contraction immediately followed by 15 seconds of passive static hamstring stretching. For the static group, the participants were asked to stretch by hanging a leg over a table for 30 seconds. Subjects in all groups performed the exercises three days per week for 4 weeks. The active straight leg raising (ASLR) test, active knee extension (AKE) test, and vertical jump test were performed before the intervention and after 1, 2, and 4 weeks. Results: The SS, HR, and CR techniques effected positive improvement in hamstring flexibility and vertical jump performances but neither of the stretching methods had any statistically significant different effects according to group, although there were interactions (between group and time) in the ALSR group from 1 week to 2 week and in the AKE test from pretest to 1 week. Conclusion: Based on the results of the current study, SS, HR, and CR were shown to affect hamstring flexibility and vertical jump performance in healthy adults. In particular, it was determined that within a short period, hamstring flexibility could be attributed more to CR than to SS.

Effects of a low-FODMAP enteral formula on diarrhea on patients in the intensive care unit

  • Bae, Eunjoo;Kim, Jiyoon;Jang, Jinyoung;Kim, Junghyun;Kim, Suyeon;Chang, Youngeun;KIM, MI YEON;Jeon, Mira;Kang, Seongsuk;Lee, Jung Keun;Kim, Tae Gon
    • Nutrition Research and Practice
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    • 제15권6호
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    • pp.703-714
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    • 2021
  • BACKGROUND/OBJECTIVES: A dietary restriction on the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) has been reported to be effective in the treatment of gastrointestinal (GI) tract complications. Enteral nutrition (EN) is widely used for patients who cannot obtain their nutritional requirements orally, but many studies have reported EN complications, especially diarrhea, in up to 50% of patients. SUBJECTS/METHODS: We performed a single-center, non-randomized, controlled trial to determine the effects of a low-FODMAP enteral formula on GI complications in patients in intensive care units (ICUs). Patients in the ICU who needed EN (n = 66) were alternately assigned to the low-FODMAP group (n = 33) or the high-FODMAP group (n = 33). RESULTS: Anthropometric and biochemical parameters were measured, and stool assessment was performed using King's Stool Chart. We excluded patients who received laxatives, GI motility agents, proton pump inhibitors, antifungal agents, and antibiotics other than β-lactams. There were no differences in GI symptoms during 7 days of intervention, including bowel sound, abdominal distension, and vomiting between the 2 groups. However, diarrhea was more frequent in the high-FODMAP group (7/33 patients) than the low-FODMAP group (1/33 patients) (P = 0.044). CONCLUSIONS: Our results suggest that a low-FODMAP enteral formula may be a practical therapeutic approach for patients who exhibit enteral formula complications. Our study warrants further randomized clinical trials and multicenter trials.

Acupuncture Treatment for Shoulder Impingement Syndrome: A Review of Randomized Controlled Trials

  • Park, Jae Eun;Kim, Woo Young;Lee, Soo Jin;Oh, Da Yoon;Lee, Min Cheol;Jeon, Myung Kyu;Kim, Hyeon Jin;Ahn, Jae Young;Yang, Su Hyeon;Choi, Yun Young;Shin, Na Young;Nam, Hye Jin
    • Journal of Acupuncture Research
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    • 제38권3호
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    • pp.175-182
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    • 2021
  • To evaluate the effectiveness of acupuncture treatment for shoulder impingement syndrome (SIS) a literature review was conducted of randomized controlled trials (RCTs) where acupuncture was used as an intervention for patients diagnosed with SIS. Relevant clinical studies (N = 181) were retrieved from several databases based on the inclusion/exclusion criteria, and the interventions and results were analyzed. Six RCTs were selected to review based on the inclusion and exclusion criteria. In all 6 studies, the acupuncture treatment group showed significant positive changes in indicators evaluating pain, disability, and quality of life. A significant decrease in the evaluation indicators (Shoulder Pain and Disability Index, numeric rating scale, Visual Analogue Scale, Constant Murley Shoulder Assessment Score, patient's global assessment, and doctor's global assessment) and a significant increase in the questionnaire scores (UCLA, AL-score, EuroQol 5 Dimension Self-Report Questionnaire, and disabilities of the arm, shoulder, and hand) were observed. In addition, 1 study showed similar improvements in pain and quality of life measures in the acupuncture group and corticosteroid injection group. No major side effects were reported. Acupuncture may be an effective and safe treatment for SIS however, further RCTs are required.

십자인대 손상에 대한 국내·외 한의치료 고찰 (A Clinical Research Analysis of the Korean Medicine for Cruciate Ligament Injury)

  • 김호걸;임주하;홍수민;구지향;하현주;오민석
    • 한방재활의학과학회지
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    • 제31권3호
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    • pp.73-84
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    • 2021
  • Objectives The objective of the study is to review the Korean traditional medicine treatment used in cruciate ligament injury. Methods According to patients, treatment methods, research design, evaluation tools, outcome, we searched for studies which performed Korean traditional medical treatment on patient with cruciate ligament injury. Results In 11 studies, total number of patents were 78. Patients were conducted with 11 kinds of treatment, which is acupuncture, herbal medicine, pharmacopuncture, electro-acupuncture, burning acupuncture, moxibustion, physiotherapy, exercise, Chuna and cupping. The most commonly used measurement was visual analog scale. Conclusions Throughout the study, we could organize Korean traditional medicine treatment for patient with cruciate ligament injury. However it is difficult to figure out among the 11 intervention which interventions were effective in improving symptom. Therefore, further researches like randomized clinical trial and systematic review is needed in order to enhance the evidence of the Korean traditional medicine.

만성 긴장성 두통에 대한 양측 완골과 풍지혈 전침 치료의 효과: 단일맹검 무작위 배정 대조군 파일럿 연구 (Effect of Electroacupuncture on Both Side Acupuncture Point GB12 and GB20 for Chronic Tension Type Headache)

  • 전준영;이종수
    • 한방재활의학과학회지
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    • 제29권1호
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    • pp.21-29
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    • 2019
  • Objectives This study is designed to verify the effectiveness of electroacupuncture (EA) on both side acupuncture point GB12, GB20 for chronic tension type headache (CTTH). Methods Subjects aged 18-65 years who had suffered from CTTH for more than 3months were recruited from September 2016 to May 2017. Thirty subjects were voluntarily recruited and they were randomly divided into 2 groups; 15 to EA group, another 15 to sham-EA group. The treatment sessions were performed every 2-4 days for a total of three sessions over 1 week. The symptoms of headache were assessed before the treatment and after a week from the last treatment by visual analogue scale (VAS), headache frequency (HF), Korean Headache Impact Test-6 (KHIT-6). Demographic characteristics of all participants were compared between the groups upon using chi-square test. Wilcoxon signed rank test was used to evaluate the values between baseline and follow-up. Wilcoxon rank sum test was performed to evaluate the differences between groups. p-values less than 0.05 were considered as significant. Results Before and after the intervention, no difference in VAS and KHIT-6 was observed between groups. HF of EA group decreased significantly compared with that of sham-EA group. Within the EA group VAS, HF and KHIT-6 decreased significantly after the treatment. Meanwhile, only KHIT-6 decreased significantly after the treatment in sham-EA group. Conclusions This study suggests that EA on both side acupuncture point GB12 and GB20 is applicable to improve symptoms in patients with CTTH.

비골신경마비에 대한 국내 한의치료 임상연구 동향 분석 (A Clinical Research Analysis of the Korean Medicine for Peroneal Nerve Palsy)

  • 홍수민;이은정
    • 한방재활의학과학회지
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    • 제29권3호
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    • pp.61-74
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    • 2019
  • Objectives This study aimed to review clinical studies about Korean medicine used in peroneal nerve palsy. Methods In 11 online databases (Earticle, Research Information Sharing Service, Oriental Medicine Advanced Searching Integrated System, KMbase, Korean Traditional Knowledge Portal, National Digital Science Library, MEDLINE/Pubmed, Ebscohost, Cochrane CENTRAL, EMBASE, China National Knowledge Infrastructure), we searched clinical studies about Korean medicine. Among the studies that we've searched, we excluded the studies that are not related to Korean medicine, case reports, randomized controlled trials and retrospective studies. As a result, 16 case studies and 1 randomized controlled trial are included. Results Total number of patients was 123. In these studies, acupuncture (100%), herbal medicine (58.8%), pharmacopuncture (58.8%), Korean physical therapy (58.8%), moxibustion (41.1%), cupping (41.1%) etc. were used. In acupuncture, GB34 and ST36 were most frequently used. Most of the herbal medicines used in these studies were different. Range of movement were most frequently used in outcome measure. Conclusions In this study, we reviewed studies about Korean medicine used in peroneal nerve palsy. It was difficult to clearly determine which intervention has improved the symptom. In the future, Further clinical studies will be needed to retain the evidence for the treatment of peroneal nerve palsy. And also more randomized controlled clinical trials to prove the efficacy of Korean medicine will be needed.