• 제목/요약/키워드: randomized controlled trial

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An 8-wk, randomized, double-blind, placebo-controlled clinical trial for the antidiabetic effects of hydrolyzed ginseng extract

  • Park, Soo-Hyun;Oh, Mi-Ra;Choi, Eun-Kyung;Kim, Min-Gul;Ha, Ki-Chan;Lee, Seung-Kwon;Kim, Young-Gon;Park, Byung-Hyun;Kim, Dal-Sik;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • 제38권4호
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    • pp.239-243
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    • 2014
  • Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

비만 환자에 대한 태음조위탕(太陰調胃湯) 임상연구 - 무작위배정, 이중맹검, 위약·대조군 임상시험 - (Clinical Trial of Taeeumjowui-Tang(Taiyintiaowei-tang) on Obese Patients - Randomized, Double Blind, Placebo-Controlled Study -)

  • 이지은;송윤경;임형호
    • 한방재활의학과학회지
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    • 제20권4호
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    • pp.197-213
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    • 2010
  • Objectives : The clinical trial was designed to investigate the safety and effects of Taeeumjowui-tang(Taiyintiaowei-tang) extracts on the change of the weight, body compositions, serum in obese patients. Methods : This was a 12-weeks, randomized, double blind, placebo-controlled clinical trial. Patients with a body mass index of either greater than $30kg/m^2$ or between 27 and $30kg/m^2$ with controlled hypertension, diabetes, hyperlipidemia were considered eligible. Participants of 41 obese patients were randomized either to Taeeumjowui-tang(Taiyintiaowei-tang)(23) or placebo(18). After 12 weeks of treatment, we measured anthropometric factors(weight, height, waist circumference, BMI(body mass index) etc.), abdominal fat area by CT(computed tomography)scanning, serum lipid(total cholesterol, tryglyceride, HDL-cholesterol, LDL-cholesterol), blood lever of variety(AST, ALT, BUN, creatinine etc.). Adverse events also evaluated. Results : After 12 weeks of treatment mean weight, waist-circumference, total cholesterol, LDL-cholesterol and score of KEAT-26 were significant changed in Taeeumjowui-tang(Taiyintiaowei-tang). There were no serious adverse events in either groups. Conclusions : There were limited in this study that is conducted within a short period of 12 weeks. but its weight and WC(waist circumference), WHR(waist hip ratio), total cholesterol, LDL-cholesterol and score of KEAT-26 loss effect was significant and it had few adverse events.

기능성 소화불량에 대한 육군자탕 엑스과립의 사상체질별 치료효과: 위약 대조, 이중 맹검, 무작위 시험 (Effects of a Herbal Medicine, Yukgunja-Tang Extract Granule, on Functional Dyspepsia Patients by Sasang Constitution: Placebo-Controlled, Double-Blind, Randomized Trial)

  • 전수형;김종원
    • 사상체질의학회지
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    • 제30권2호
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    • pp.42-54
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    • 2018
  • Objectives This study was aimed to compare effects of Yukgunja-tang (YGJT) extract granule on functional dyspepsia (FD) by sasang constitution. Methods A placebo-controlled, double-blind, randomized, two-center trial was performed. We obtained 3D face images of FD patients participating in this study using face-only scanner and classified them into two types as narrow face and wide face by 3D facial shape diagnosis system (3-FSDS). 96 subjects (48 subjects per type) were enrolled and were randomly allocated into treatment or control groups in a 2:1 ratio. YGJT extract granule or placebo were administered to each group during the 8 week treatment period. One of sasang constitutional specialist diagnosed their constitutions by referring to questionnaires and 3D face images. The primary outcome was total dyspepsia symptom scale (TDS scale), the secondary outcomes were single dyspepsia symptom scale (SDS scale), visual analog scale (VAS) and so on. This trial was registered with clinical research information service identifier: KCT0001920, 15 May, 2016. Results In the Taeeumin treatment group, the TDS scale was significantly decreased after 8 weeks compared to the control group (t=2.331, p=0.025) and the SDS scale also significantly decreased. (t=2.042, p=0.048). The specific effects of the YGJT extract granule without the placebo effect on the Taeeumin with functional dyspepsia were 30.61% in TDS scale and 28.33% in SDS scale. Conclusions The effects of Yukgunja-tang extract granule on functional dyspepsia was different according to Sasang constitution. So the constitution should be considered in randomized controlled trials using herbal extract granules.

봉독을 이용한 무작위배정 임상연구의 국내 현황 (The Review on the Randomized Controlled Clinical Trials of Bee Venom in the Journal of Korean Medicine)

  • 이용석;이영준;한창현
    • 한방재활의학과학회지
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    • 제23권3호
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    • pp.87-106
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    • 2013
  • Objectives We will provide basic information on bee venom clinical tests and aid the practical use of bee venom in such tests, through examination of RCT research related to bee venom that was reported domestically. Methods We collected 365 articles on Bee venom study result from the OASIS system using the Keyword 'bee venom, apitoxin, apitherapy, bee sting'. The initially selected theses were primarily screened for clinical research. Out of these, case studies and non randomized controlled trial (non-RCT) were ruled out. As a result, 39 studies of randomized controlled trial (RCT) research were chosen as the subjects of study. Results RCT research related to bee venom was first presented in 2003, and 39 studies have been published until 2012. 18 studies were tests to confirm the effectiveness of bee venom, 7 studies were comparisons between SBV and BV, and 13 studies were comparisons with other types of treatment. Research conducted through appropriate randomization methods were 20 studies, and inappropriate randomization methods were used in 19 studies. In therms of Jadad score, 12 studies received 4~5 points, 15 studies received 1-3 points, and 12 studies received zero point. Conclusions In order to assure good quality RCT research, appropriate guidelines should be provided, and proper evaluation standards should be established. In-depth study is needed concerning the difference of responses to treatment according to the types of treatment received. A standardization of treatment should be reached as a result.

마황복용이 성인여성의 상태-특성 불안에 미치는 영향: 무작위배정 이중맹검 임상연구 (Effects of Ephedra on the State-Trait Anxiety in Female Adults: A Double-Blind Randomized Controlled Study)

  • 양창섭;형례창;정현숙;김락형;곽민정;서의석;장인수
    • 대한한방내과학회지
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    • 제28권2호
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    • pp.346-353
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    • 2007
  • Background : Over a thousand years of clinical preparation of Ephedrain traditional Korean medicine has confirmed effectiveness and security. Recently. Ephedra-containing herbal preparations to treat obesity are common. The aim of this study is to identify effects of Ephedra on psychological anxiety. Objectives : To determine effects of Ephedraon psychoactivity and autonomic nervous system. Methods : The study design was a double-blind randomized controlled trial. The subjects of this study were healthy adults. They were allocated to either the Ephedragroup (N =66) or the placebo group (N =32), Ephedra(8 g) or a placebo in similar opaque capsules was given twice a day for 2 weeks. Anxiety score was estimated with State-Trait Anxiety Inventory before first and after last medication. 36 of the Ephedragroup and 24 of the placebo group finished the trial and were analyzed. Paired samples T-test and independent samples T-test were applied to statistical analysis. Results : The following result was obtained: After taking Ephedra. state anxiety increased significantly. In the placebo group. both state and trait anxiety increased although significance was not reached. Conclusions : It is concluded that the intake of Ephedraplays a significant role in the increase of anxiety in healthy adults. It is suggested that anxiety level change should be considered when using Ephedra in clinics.

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Localized probiotic-guided pocket recolonization in the treatment of chronic periodontitis: a randomized controlled clinical trial

  • Kumar, Vikram;Singhal, Rameshwari;Rastogi, Pavitra;Lal, Nand;Pandey, Shivani;Mahdi, Abbas Ali
    • Journal of Periodontal and Implant Science
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    • 제51권3호
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    • pp.199-212
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    • 2021
  • Purpose: This randomized clinical placebo-controlled trial was conducted to evaluate the effectiveness of Lactobacillus reuteri as a probiotic in guided pocket recolonization (GPR) for the treatment of chronic periodontitis (CP) adjunctive to scaling and root planing (SRP). Methods: Forty-eight CP patients were randomly assigned to 3 treatment groups: group 1 (SRP+placebo), group 2 (SRP+single application of probiotic), and group 3 (SRP+incremental application of probiotic). Clinical parameters were evaluated at baseline and at 8, 12, and 24 weeks, whereas biochemical parameters were measured at baseline and 12 weeks. Results: At 24 weeks, the probing pocket depth and clinical attachment level improved in all 3 groups from baseline with no significant intergroup differences; however, a statistically significant difference was observed in localized plaque and gingival scores between groups 1 and 3 (P<0.05). At 12 weeks, matrix metalloproteinase-8 (MMP-8), nitric oxide (NO), and gingipains-R (Rgps) levels improved in all 3 groups, with statistically significant differences between groups 1 and 3 for MMP-8 and NO (P<0.05), but no difference for Rgps levels. Conclusions: Within its limitations, the results of this study show that incremental 3-time application of L. reuteri as a probiotic led to improvements in clinical and biochemical parameters. This protocol can be a useful adjunct to SRP in the non-surgical management of CP.

자살시도자에 대한 무작위대조군연구의 등록 현황 분석: WHO-ICTRP를 중심으로 (Analysis of Registration Information of Randomized Controlled Clinical Trials on Suicide Attempters Based on WHO-ICTRP)

  • 박민령;이지원;황인준;권찬영
    • 동의신경정신과학회지
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    • 제34권3호
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    • pp.213-234
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    • 2023
  • Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

직장 탈출증에 대한 보중익기탕과 수술 치료 병용요법의 임상 연구 고찰 - 무작위 대조군 연구를 중심으로 (A Review of Clinical Studies about Bojungikgi-tang Combined with Surgical Therapy on Rectal Prolapse - Focusing on Randomized Controlled Trial)

  • 공경환;김도현
    • 동의생리병리학회지
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    • 제38권2호
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    • pp.59-65
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    • 2024
  • Rectal prolapse is a condition where the rectal wall protrudes outside the anus. While it is a rare condition, it can cause discomfort for patients due to the protrusion of the rectal structure, discharge of mucus and blood, fecal incontinence, constipation, and other inconveniences. In this review, we analyzed a randomized controlled trial (RCT) study that used the herbal medicine Bojungikgi-tang(Buzhongyiqi-tang) as a complementary therapy to improve the weaknesses and side effects of the standard treatment, surgical therapy, for rectal prolapse. The analysis included 12 RCT studies, and in all studies, the prescription involved the use of Astragali Radix at the highest dosage. Among the 11 studies that evaluated efficacy, 7 studies showed a significant effect compared to the control group. In all 3 studies that evaluating recurrence rates and all 5 studies investigating complications after surgery, the experimental group showed significant effects. Based on these findings, this study could be considered as a foundational evidence for the application of bojungikgi-tang(Buzhongyiqi-tang) in clinical practice in Korean medicine for patients with rectal prolapse. It could also serve as foundational data for future research.

좌섬요통(挫閃腰痛)에 있어 봉약침(蜂藥鍼)의 효과(效果)에 대한 연구(硏究)(A Randomized Controlled Trial; Double Blinding) (The Effectiveness of Bee Venom Acupuncture Therapy on the Treatment of Sprain of L-spine(A Randomized Controlled Trial; Double Blinding))

  • 김경태;송호섭
    • Journal of Acupuncture Research
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    • 제22권4호
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    • pp.113-120
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    • 2005
  • objectives : This study was to evaluate the effectiveness of Bee Venom acupuncture therapy for sprain of L -spine. Methods : A randomized double blinding study of bee venom acupuncture therapy was conducted on sprain of L-spine. We divided sprain of L-spine patient into 2 groups: one group with both acupuncture and saline acupuncture therapy, and another group with both acupuncture and bee venom acupuncture therapy. To estimate the efficacy of treatment that applied for two groups, we used visual analog scale(VAS) and oswestry disability index(ODI). We compared the VAS and ODI score of two groups statistically. Results : 1. As a result of evaluation by using visual analog scale(VAS) and oswestry disability index(ODI), treatment score after 5 days was marked more higher than score before treatment and treatment score after 10 days treatment was more higher than treatment score after 5 days on each groups. 2. After 10 days treatment, acupuncture and bee venom acupuncture therapy group had significant result on visual analog scale(VAS) and oswestry disability index(ODI) compared with acupuncture and saline acupuncture therapy group. Conclusion : Bee Venom acupuncture therapy can be used with acupuncture therapy for highly effective treatment for sprain of L-spine.

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폐암으로 폐 절제술을 시행한 환자에게 적용한 운동 효과: 체계적 문헌고찰과 메타분석 (Exercise Effect Applied to Patients Who Underwent Lung Resection with Lung Cancer: Systematic Review and Meta-Analysis)

  • 박영주;배필원
    • 한국콘텐츠학회논문지
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    • 제18권6호
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    • pp.652-666
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    • 2018
  • 본 연구는 폐암으로 폐절제술을 시행 받은 환자에게 적용한 운동 중재를 파악하고 그 효과의 차이를 규명하기 위하여 체계적 문헌고찰 및 메타분석을 실시하였다. 국내외 전자데이터베이스를 통해 1990년부터 2016년까지 총 1,322개의 논문이 검색되었으며, 문헌 선별 과정을 통해 최종 13개의 문헌을 선정하였다. 최종적으로 925명을 대상자가 포함된 8개의 대조군이 있는 무작위 대조군(randomized controlled trial; RCT)논문와 5개의 대조군이 있는 비무작위 대조군(non-randomized controlled trial; NRCT)논문을 확인하였다. 결과변수에 대한 중재의 효과크기를 메타분석한 결과, 중재군의 건강관련 삶의 질 EORTC QOL-C13/30 (the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire) (MD-0.50 95 % CI -0.83-0.18)과 중재군의 건강관련 삶의 질 SF-36 PCS (the Medical Outcomes 36-Item Short Form Health Survey PCS) (MD 0.75, 95 % CI 0.41-1.10)에서 대조군보다 통계적으로 유의하게 높게 나타났다. 따라서 본 연구의 결과는 운동 중재가 폐암으로 폐 절제술을 시행 받은 환자의 건강관련 삶의 질을 잠재적으로 향상시킬 수 있음을 시사한다.