• 제목/요약/키워드: randomized controlled double blind study

검색결과 209건 처리시간 0.031초

Effects of whey protein supplementation prior to, and following, resistance exercise on body composition and training responses: A randomized double-blind placebo-controlled study

  • Park, Yeram;Park, Hun-Young;Kim, Jisu;Hwang, Hyejung;Jung, Yanghoon;Kreider, Richard;Lim, Kiwon
    • 운동영양학회지
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    • 제23권2호
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    • pp.34-44
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    • 2019
  • [Purpose] The composition of protein supplements, the consumption timing immediately before and after resistance exercise training (RET), and the quantity of protein supplementation may be important factors for the im-provement of muscle mass and function. Although these factors should be considered comprehensively for effective improvement of muscular function in protein supplementation, relatively few studies have focused on this area. Therefore, this study was designed to investigate whether a protein blend supplement before and after resistance exercise for 12 weeks would be effective in increasing muscular function. [Methods] In total, 18 participants were randomly assigned to a placebo (PLA) or protein blend supplement (PRO) group. All subjects followed the same training routine 3 times per week for 12 weeks, taking placebo or protein supplements immediately before and after each exercise session. The protein supplement consisted of 40 g of blend protein, including hydrolyzed whey protein. The RET consisted of lower body (barbell squat, dead lift, seated leg extension, and lying leg curl) and upper body (bench press, barbell rowing, preacher bench biceps curl, and dumbbell shoulder press) exercises. A repetition was defined as three sets of 10-12 times with 80% of one repetition maximum (1RM). [Results] Although the PRO group had a lower protein intake in terms of total food intake than the PLA group, the mean changes in muscle circumference, strength, and exercise volume increased, especially at week 12, compared to the PLA group. [Conclusion] These results suggest that the composition and timing of protein intake are more important than the total amount.

심적환$^{(R)}$이 흉통 흉민에 대하여 미치는 영향에 대한 다기관 무작위배정 이중맹검 임상연구 (Effect of Cardiotonic Pills$^{(R)}$ on Chest Pain and Discomfort: A Multi-center Double-blind Randomized Controlled Trial.)

  • 장인수;고창남;이인;박정미;김세현;김상우
    • 대한한의학회지
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    • 제26권2호
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    • pp.95-104
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    • 2005
  • Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

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The fruit of Acanthopanax senticosus Harms improves arterial stiffness and blood pressure: a randomized, placebo-controlled trial

  • Oh, Eunkyoung;Kim, Youjin;Park, Soo-yeon;Lim, Yeni;Shin, Ji-yoon;Kim, Ji Yeon;Kim, Ji-Hyun;Rhee, Moo-Yong;Kwon, Oran
    • Nutrition Research and Practice
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    • 제14권4호
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    • pp.322-333
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    • 2020
  • BACKGROUND/OBJECTIVES: Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. SUBJECTS/METHODS: A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. RESULTS: Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). CONCLUSIONS: These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.

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

  • 정수임;남수진;;;강미영
    • 한국식품과학회지
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    • 제51권2호
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    • pp.182-187
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    • 2019
  • 본 연구는 슈퍼홍미 미강 추출물이 폐경 후 갱년기 증상에 및 대사 개선 효과를 확인하고자 수행되었다. 무월경이 지속된 지 5년 미만의 여성을 대상으로 12주동안 진행되었으며 위약대조군 15명, 실험군 15명으로 배정하였고, 1일 2개의 캡슐을 섭취하도록 하였다(슈퍼홍미 미강추출물 700 mg/day). 시험 종료 후 슈퍼홍미 미강 추출물 섭취군의 체중과 BMI 그리고 중성지질과 및 총콜레스테롤은 수준이 유의하게 감소하였다. 혈중 HDL 콜레스테롤과 ApoA1 농도는 약 10% 증가하여 지질대사 개선에 효과를 기대할 수 있었다. 항당뇨과 관련된 지표 중 혈중 glucose와 인슐린이 유의하게 감소하여 인슐린 저항성 지표인 HOMA-IR이 감소한 것을 확인할 수 있었고, 아디포넥틴 수준이 유의하게 증가하였으며, $TNF-{\alpha}$는 슈퍼홍미 미강 추출물 섭취군에서 투여 전보다 유의하게 감소하여 폐경 이후 당질대사 개선에 도움을 줄 수 있을 것으로 보인다. 항산화활성 분석 결과 SOD1, GSH 그리고 TBARS 수준이 실험군에서 감소하였으며, AOPP 는 유의적인 차이를 보이지 않았다. 여성호르몬 중 $17{\beta}-estradiol$과 progesterone 농도는 위약대조군에서 유의하게 감소하였으나 실험군은 섭취기간동안 호로몬 농도를 유지한 것으로 나타나 대조군에 비해 높은 수준을 나타났다. 폐경을 겪은 여성들은 여성호르몬 저하로 인해 갱년기 증상 및 대사증후군 발병 가능성이 증가하는데 슈퍼홍미 미강과 같은 기능성 식품 섭취로 대사증후군 위험인자들에 대한 호전이 높을 것이라 보고 이러한 연구 결과는 갱년기 여성 건강에 시사하는 바가 크다고 생각된다.

Effects of pumpkin seed oil and saw palmetto oil in Korean men with symptomatic benign prostatic hyperplasia

  • Hong, Hee-Ok;Kim, Chun-Soo;Maeng, Sung-Ho
    • Nutrition Research and Practice
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    • 제3권4호
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    • pp.323-327
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    • 2009
  • This study was to investigate the role of complementary and alternative medicine in the prevention and treatment of benign prostatic hyperplasia. For this purpose, a randomized, double-blind, placebo-controlled trial was performed over 12 months on 47 benign prostatic hyperplasia patients with average age of 53.3 years and international prostate symptom score over 8. Subjects received either sweet potato starch (group A, placebo, 320 mg/day), pumpkin seed oil (group B, 320 mg/day), saw palmetto oil (group C, 320 mg/day) or pumpkin seed oil plus saw palmetto oil (group D, each 320 mg/day). International prostate symptom score, quality of life, serum prostate specific antigen, prostate volume and maximal urinary flow rate were measured. In groups B, C and D, the international prostate symptom score were reduced by 3 months. Quality of life score was improved after 6 months in group D, while those of groups B and C were improved after 3 months, compared to the baseline value. Serum prostate specific antigen was reduced only in group D after 3 months, but no difference was observed in prostate volume in all treatment groups. Maximal urinary flow rate were gradually improved in groups B and C, with statistical significance after 6 months in group B and after 12 months in group C. None of the parameters were significantly improved by combined treatment with pumpkin seed oil and saw palmetto oil. From these results, it is suggested that administrations of pumpkin seed oil and saw palmetto oil are clinically safe and may be effective as complementary and alternative medicine treatments for benign prostatic hyperplasia.

Action observation training enhances upper extremity function in subacute stroke survivor with moderate impairment: a double-blind, randomized controlled pilot trial

  • Kim, Chang-Heon;Bang, Dae-Hyouk
    • 대한물리의학회지
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    • 제11권1호
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    • pp.133-140
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    • 2016
  • PURPOSE: This study's aim was to investigate the effects of an action observational training in subactue stroke patients with moderate impairment. METHODS: 22 participants (men=13, women=9) with hemiparesis were randomly assigned to action observation training group or task-oriented training group. Patients in both group underwent a patient-specific multidisciplinary rehabilitation program. Participants in the action observation group (mean age, $62.78{\pm}9.85$) were asked to watch the video scene, in the knowledge that they would then attempt to perform the same movement task after watching. The control group (mean age, $61.49{\pm}8.64$) practiced the same tasks, without watching the video. To evaluate upper limb function, the upper extremity part of the Fugl-Meyer Assessment upper extremity and the Box and Block Test were used. The modified Barthel index was used to assess ADLs, and the modified Ashworth scale were used to assess spasticity in the upper extremity. RESULTS: The action observational training group exhibited greater changes in the Fugl-Meyer assessment upper extremity (P<0.05; 95% CI, 0.929 - 6.403), the Box and Block test (P<0.05; 95% CI, 0.086 - 5.913), and the modified Barthel index (P<0.01; 95% CI, 2.483 - 12.627) between groups. And the modified Ashworth scale (P>0.05; 95% CI, -0.402 to 0.624) did not show significantly different between groups. CONCLUSION: These findings suggest that action observational training may be more helpful to improve upper-extremity function than physical training only in subactue patients with moderate impairment after stroke.

제왕절개술후 통증치료시 지속적 경막외 국소마취제와 Tramadol의 병용투여의 효과 (Continuous Epidural Infusion of Bupivacaine with Tramadol for Post-Cesarean Analgesia)

  • 강포순;조재군
    • The Korean Journal of Pain
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    • 제11권1호
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    • pp.54-59
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    • 1998
  • Background: Tramadol administered epidurally is known to have one-thirtieth the potency of morphine for treatment of pain following abdominal surgery. We designed a prospective, randomized, controlled study to evaluate the analgesic efficacy and safety of combined epidural infusion of bupivacaine and tramadol with 2-day infusor as ompared to bupivacaine and morphine combined epidural infusion. Methods: Sixty healthy women scheduled for Cesarean delivery were assigned randomly in double- blind fashion: Group 1 (n=20) were given a mixture of morphine 10 mg(1 ml), 0.5% bupivacaine 40 ml and normal saline(NS) 40 ml; Group 2(n=20) a mixture of tramadol 300 mg(6 ml), 0.5% bupivacaine 40 ml and NS 54 ml; Group 3(n=20) or a mixture of tramadol 500 mg(10 ml), 0.5% bupivacaine 50 ml and NS 50 ml, of continuous dose via epidural route following 1% lidocaine 6 ml as bolus dose for 48 hours postoperatively. We evaluated the analgesic efficacy and side effects of these three groups using visual analogue pain scale (VAPS) and verbal rating scale (VRS). Results: VAPS of group 1 and 3 were lower than group 2, and VAPS of group 1 was lower than group 3(12, 24, 36, 48 hours). VRS of group 1 and 3 were lower than group 2 (12, 24, 36 hours). There were incidences of pruritus was 16 patients in group 1. Conclusions: Tramadol does possess the analgesia effect of morphine, but has the added analgesia following increment. Further research to determine the most effective administration method and reguired dosage of tramadol is further needed.

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임상시험을 통한 3-Amino Propane Phosphoric Acid(3-APPA)의 노화억제 효과 확인(제1보) (Clinical Confirmation of 3-APPA's Anti-aging effects)

  • 하재현;김종일
    • 대한화장품학회지
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    • 제22권1호
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    • pp.60-69
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    • 1996
  • 3-APPA는 생체내 물질 Υ-amino butyric acid와 유사한 구조를 갖는 물질로서 human fibroblasts 3-dimensional culture system 등의 in vitro 시험에서 collagen 합성촉진 효과, 세포증식 효과를 나타내며, hairless mouse를 이용한 동물시험에서도 collagen 합성이 증가되는 것으로 보고된 바 있다. 또한 피부 안정성에서도 우수한 결과를 보여줌으로서 화장품 분야에서 새로운 노화억제 물질로서 주목을 받게 되었다. 본 시험에서는 180명의 피검자를 대상으로 3개월간의 임상시험을 통하여 새로운 노화억제 물질인 3-APPA의 효능을 기존의 GABA 유사물질, aminopropane sulfonic acid와 비교하였다. 본 시험은 double-blind, randomized, vehicle-controlled clinical study로서 180명의 피검자를 APSA군, 3-APPA군, vehicle군으로 분류한 후 3개월간 매일 저녁 취침 전, 안면에 시험제품을 사용하도록 하였으며, 사용 전, 사용 1주후, 2주후, 6주후, 12주후 5회 설문지를 통하여 피부상태를 조사하였다. 각 설문내용은 피부 건조도, 피부 탄력도, 피부 주름량, 피부 윤기도, 피부 거칠기 정도에 대한 5개 질문으로 구성된 효능에 관한 질문과 흡수정도, 끈적임, 매끄러움, 보습력, 보습지속성, 전체적인 사용감에 대한 6개 질문으로 구성된 사용성에 관한 것이었다. 각 질문에 대하여는 매우 좋음 1점, 좋은 2점, 보통임 3점, 나쁨 4점, 매우 나쁨 5점 사이에서 답할 수 있도록 하였다. 시험 결과 APSA군은 6주와 12주후 피부 건조도, 피부 거칠기 항목에서 사용전에 비하여 유의한 차이를 나타내었다. 3-APPA군은 6주후 피부 건조도, 피부 거칠기, 피부 탄력도 항목에서 시료사용전에 비해 유의한 차이를 나타내었으며 12주후에는 피부 건조도, 피부 탄력도, 피부 윤기도, 피부 거칠기 항목에서 유의한 차이를 나타내었다. 12주후 APSA군은 피부 주름, 피부 탄력도 항목에서 vehicle 사용 피검자군에 비하여 유의적인 차이를 나타내었으나 3-APPA군은 피부 탄력도, 피부 주름량, 피부 윤기 항목에서 vehicle군에 비하여 유의적인 차이를 나타내었다. 결론적으로 3-APPA와 APSA 사이에 유의적인 차이가 있지는 않았으나 3-APPA군은 APSA군에 비하여 6주, 12주에서 사용전과 유의한 차이를 나타내는 항목이 많았으며 12주에서 vehicle과 유의적인 차이를 나타내는 항목도 많으므로 3-APPA가 APSA 보다 광범위한 피부노화 억제 효과를 갖는 물질이라고 할 수 있다.

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단기간 귀리 추출물 섭취의 혈당 및 콜레스테롤 저하 효과 평가 (Evaluation the Effects of Short Term Intake Avena sativa Extracts on Blood Glucose and Cholesterol Level)

  • 김하나;이인수;신경숙;윤순규;이부형;윤승규;최진우;서인범
    • 한국콘텐츠학회논문지
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    • 제15권3호
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    • pp.272-279
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    • 2015
  • 최근 혈당조절에 도움이 되는 다양한 천연추출물에 대한 연구가 진행되고 있다. 귀리는 다양한 생리효능이 있는 것으로 알려져 있는데 특히 ${\beta}$ 클루칸은 체내 혈중 콜레스테롤 수치를 낮추어 심혈관 질환을 예방하고 비만과 관련된 성인병 예방에 효과를 보이는 것으로 보고되고 있다. 이에 본 연구는 상품화된 귀리 추출물로 이루어진 다운앤컨트롤(비엠제약)을 이용하여 6주간 무작위, 이중맹검, 실험군-대조군 임상 연구를 통해 혈당 및 혈중 콜레스테롤에 대한 효과를 평가한 결과, 통계학적으로 유의한 차이를 보이지는 않았지만 당화알부민은 각각 시험군에서 50.33% 감소, 대조군에서 37.91% 감소 및 중성지방은 시험군에서 7.51% 감소, 대조군에서 3.98% 증가로 상대적으로 차이를 보여 시험약의 혈당저하 효과 및 중성지방의 감소효과를 일부에서 관찰할 수 있었다.

Effects of Korean Red Ginseng on Dry Mouth: A Randomized, Double-Blind, Placebo-Controlled Trial

  • Park, Jae-Woo;Lee, Beom-Joon;Bu, Young-Min;Yeo, In-Kwon;Kim, Jin-Sung;Ryu, Bong-Ha
    • Journal of Ginseng Research
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    • 제34권3호
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    • pp.183-191
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    • 2010
  • Dry mouth is easily neglected if not associated with oral diseases. Consequently, xerostomatic patients often use unconventional therapies. In traditional Korean medicine, Korean red ginseng (KRG) has long been used to relieve dry mouth. However, no clinical trials have investigated whether KRG actually has an effect on dry mouth. This study was performed to evaluate the efficacy of KRG for dry mouth. We enrolled 100 volunteers with no obvious oral or salivary gland diseases and divided them into KRG and placebo groups. Each group was divided into six subgroups according to age and gender. The subjects received 6 g/day of KRG or placebo for 8 weeks. The dry mouth visual analog scale (VAS), salivary flow rate, and a dry mouth-related symptom questionnaire were evaluated at baseline and at 4 and 8 weeks. KRG treatment did not show any significant differences for any of the variables. However, KRG improved the dry mouth VAS at 4 weeks and dry mouthrelated symptoms at 8 weeks in women, but not in men. Subgroup analyses revealed that KRG markedly improved the dry mouth VAS in women of menopausal age (40 to 59 years) at 4 and 8 weeks. KRG may have beneficial effects for dry mouth in women, especially those of menopausal age, but not in men. Further investigation in post- and perimenopausal women is required to elaborate on these findings.