• Title/Summary/Keyword: Randomized Trial

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Safety and antifatigue effect of Korean Red Ginseng capsule: A randomized, double-blind and placebo-controlled clinical trial

  • Yang, Yi;Wang, Hong;Zhang, Ming;Shi, Mengxue;Yang, Cailing;Ni, Qiang;Wang, Qi;Li, Jing;Wang, Xuemei;Zhang, Chen;Li, Zhi
    • Journal of Ginseng Research
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    • v.46 no.4
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    • pp.543-549
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    • 2022
  • Background: In physical activity or labor, the human body is in a state of high intensity stress, and all parts or physiological functions of the body respond positively to maintain or balance the need for movement. The human body has many physiological changes in the process of movement, and fatigue is the external manifestation of various complex changes inside the human body. Fatigue is also a physiological mechanism of self-protection after the body reaches a certain level of activity, which can prevent the occurrence of life-threatening excessive functional failure. The generation of fatigue is a very complex process, and its mechanism has not been concluded yet. Therefore, it is an important work to search and screen the effective components of natural plants that have anti-fatigue effect and to explore their mechanism. Methods: This was a 8-week, randomized, double-blind, placebo-controlled clinical trial. A total of 110 subjects who passed physical examination were included according to the scheme design, and randomly divided into a test group which was given KRG and a placebo control group. The calculation is carried out according to the standard of sub-high-intensity exercise test. Results: There was no adverse effect on safety index of subjects after taking red ginseng capsule. After KRG treatment, subjective strength grade is significant lower than placebo treatment. Blood lactic acid content is significantly get lower after trial in KRG group, and significant lower than placebo group. Creatine phosphokinase(CK) content is significantly get lower after trial in KRG group, and significant lower than placebo group. Conclusion: According to the criterion in the test scheme, the result shows that KRG is helpful on relieving physical fatigue.

Rice-based breakfast improves fasting glucose and HOMA-IR in Korean adolescents who skip breakfast, but breakfast skipping increases aromatic amino acids associated with diabetes prediction in Korean adolescents who skip breakfast: a randomized, parallel-group, controlled trial

  • Kim, Hyun Suk;Jung, Su-Jin;Jang, Soyoung;Kim, Min Jung;Cha, Youn-Soo
    • Nutrition Research and Practice
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    • v.16 no.4
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    • pp.450-463
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    • 2022
  • BACKGROUND/OBJECTIVES: Adolescents who skip breakfast have an increased prevalence of chronic diseases. Thus, we aimed to evaluate whether the intake of rice-based breakfast had positive effects on blood glucose indices and to determine the possibility of diabetes prevalence in Korean youths who habitually skip breakfast. SUBJECTS/METHODS: In this randomized parallel-group controlled trial, 81 subjects who were suitable for compliance among 105 middle-and high-school students aged 12-18 years who usually skipped breakfast were included in this study (rice-meal group [RMG], n = 26; wheat-meal group [WMG], n = 29; general-meal group [GMG], n = 26). The RMG and WMG received a rice-based breakfast and a wheat-based breakfast for 12 weeks, respectively. The anthropometric indices, blood glucose indices, and metabolites were measured at baseline and the endpoint, respectively. RESULTS: The mean body weights in the RMG, WMG, and GMG groups at the endpoint were 62.44 kg, 61.80 kg, and 60.28 kg, respectively, and the mean body weights of the WMG and GMG groups at the endpoint were significantly higher than that at baseline (P < 0.05). The levels of fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR) values were significantly decreased in the RMG group at the endpoint compared to baseline (P < 0.05, P < 0.05, respectively). The levels of tryptophan and tyrosine in the WMG group at the endpoint were significantly higher than that those at baseline (P < 0.01, P < 0.05, respectively). CONCLUSIONS: Rice-based breakfast has positive effects on fasting insulin levels and HOMA-IR in Korean adolescents who skip breakfast. Additionally, it was found that a skipping breakfast could increase the prevalence of diabetes in adolescents who skip breakfast. Therefore, in addition to reducing breakfast skipping, it is vital to develop a rice-based menu that fits teenage preferences to prevent chronic diseases such as diabetes.

Randomized, Double-blind, and Placebo-controlled a Clinical Study for Chronic Fatigue via the Analysis of Efficacy and Safety of Gongjin-dan and Ssanghwa-tang : Study Protocol (만성피로에 대한 공진단과 쌍화탕의 안전성 및 유효성 평가를 위한 무작위배정, 이중눈가림, 위약대조 임상시험 : 임상연구 프로토콜)

  • Jun-Yong, Choi;Byungmook, Lim;Hyeun-kyoo, Shin;Kibong, Kim
    • Journal of Society of Preventive Korean Medicine
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    • v.26 no.3
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    • pp.97-108
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    • 2022
  • Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4th week, and 6th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.

Effects of Neuromuscular Electrical Stimulation on Muscle Wasting with Cancer Patient: Study Protocol for a Systematic Review (신경근전기자극치료가 암환자의 근육 손실에 미치는 영향: 체계적 문헌고찰을 위한 프로토콜)

  • Eun Soo Park;Jong Hee Kim;Soo Dam Kim;Dong Hyun Kim;Min Seok Oh;Eun Jung Lee;Hwa Seung Yoo
    • Journal of Korean Medicine Rehabilitation
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    • v.33 no.2
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    • pp.49-55
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    • 2023
  • Objectives The purpose of this study is to analyze randomized controlled trials about neuromuscular electrical stimulation for muscle wasting with cancer patient and evaluate it's motor functionality effect. Methods Studies will be searched from 7 online databases (PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure [CNKI], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]). Participants will be cancer patients with muscle loss, regardless of cause, gender, race or age, interventions will be neuromuscular electrical stimulation. Other treatments than interventions will be the control group and the main outcome will be reviewed by motor functionality effect. Results Randomized controlled trials about neuromuscular electrical stimulation for muscle wasting should be included in the study. Primary outcomes include motor functionality effect. Secondary outcomes evaluate adverse event. The data uses Review Manager Software 5.4. Conclusions The conclusion of this study will provide a basis for determining whether neuromuscular electrical stimulation treatment for muscle wasting with cancer patient treatment is an effective and safe treatment method in clinical practice.

A NEW DESIGN FOR RANDOMIZED CLINICAL TRIALS

  • Zelen Marvin
    • 대한예방의학회:학술대회논문집
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    • 1994.02b
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    • pp.261-264
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    • 1994
  • This paper proposes a new method for planning randomized clinical trials. This method is especially suited to comparison of a best standard or control treatment with an experimental treatment. Patients are allocated into two groups by a random or chance mechanism. Patients In the first group receive standard treatment; those in the second group are asked if they will accept the experimental therapy; if they decline. they receive the best standard treatment. In the analyses of results. all those in the second group. regardless of treatment. are compared with those in the first group. Any loss of statistical efficiency can be overcome by Increased numbers. This experimental plan is indeed a randomized clinical trial and has the advantage' that, before providing consent, a patient will know whether an experimental treatment is to be used.

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Acupotomy for Superior Cluneal Nerve Entrapment Syndrome: A Review of Randomized Controlled Trials

  • Hye Min Kim;Jae Soo Kim;Hyun Jong Lee;Jung Hee Lee;Sung Chul Lim;Yun Kyu Lee
    • Journal of Acupuncture Research
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    • v.41 no.2
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    • pp.87-95
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    • 2024
  • This review aims to analyze the efficacy of acupotomy in treating superior cluneal nerve entrapment syndrome (SCNES) by summarizing the findings of randomized controlled trials (RCTs). The RCTs were retrieved from seven databases (i.e., the Cochrane Library, PubMed, Embase, China National Knowledge Infrastructure, Korean Studies Information Service System, Research Information Service System, and Oriental Medicine Advanced Searching Integrated System). Seven RCTs were selected for this review. The results indicate that acupotomy is promising for providing significant pain relief and improving function in patients with SCNES. However, more high-quality RCTs are required to establish the long-term effectiveness and safety of acupotomy. This review provides valuable insights for clinicians and researchers in the management of SCNES.

Quantity and Quality Assessment of Randomized Controlled Trials in the Atopic Dermatitis (아토피 피부염 무작위배정 임상연구 논문 질 평가)

  • Park, Hye-Joo;Kwon, Ji-Hye;Yoo, Jong-Hyang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.45-57
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    • 2014
  • Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.