• The Journal of Internal Korean Medicine
• /
• v.43 no.3
• /
• pp.423-435
• /
• 2022

Purpose: The purpose of this study was to confirm the clinical efficacy of Gyeongok-go. Methods: Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Excerpta Medica dataBASE (EMBASE), Research Information Sharing Service (RISS), ScienceON, Korean Traditional Knowledge Portal (KTKP), and China National Knowledge Infrastructure (CNKI) were searched for randomized controlled clinical trials administering Gyeongok-go as an intervention, published from inception to December 31, 2021. The risk-of-bias of the included trials was assessed with the Cochrane risk-of-bias tool for randomized trials version 2. From the experimental and control groups of the selected trials, the mean value (or rate) of each outcome was extracted and statistically compared. Results: Statistically significant mean differences were in VO₂max (MD 6.82), post-exercise heart rate (MD -8.76 at 5 min, -11.58 at 30 min, -14.6 at 60 min), senescence scale (MD -6.52), Th1 cells and Th2 cells in pulmonary tuberculosis (MD 2.79 and -1.64), yin-deficient and qi-deficient score (MD -9.64 and -9.76), and phlegm-dampness score (MD 5.56). Overall risk-of-bias was 20% low risk, 80% some concerns, and 0% high risk. There were no reports of adverse events. Conclusions: Gyeongok-go is likely to have the effect of improving cardiorespiratory endurance, increasing fatigue recovery ability, reducing senescence, and enhancing immune function in tuberculosis patients. Also, it is more suitable for those who are yin-deficient or qi-deficient, and those with phlegm-dampness probably need caution.

• Korean Journal of Radiology
• /
• v.21 no.1
• /
• pp.42-57
• /
• 2020

Appropriate use and analysis of neuroimaging techniques is an inevitable aspect of clinical trials for patients with acute ischemic stroke. Neuroimaging examinations were recently used to define the core eligibility criteria and outcomes in acute ischemic stroke research. Recent clinical trials for endovascular treatment in acute ischemic stroke have also demonstrated the efficacy or safety of endovascular treatment using various imaging modalities as well as clinical indices. Furthermore, independent imaging reviews and imaging core laboratory assessments are essential to manage and analyze imaging data in order to enhance the reliability of the outcomes. Therefore, we systematically reviewed the use of neuroimaging in recent randomized clinical trials for endovascular treatment of acute ischemic stroke in order to provide a thorough summary, which would serve as a resource guiding the use of appropriate imaging protocols and analyses in future clinical trials for acute ischemic stroke. This review will help researchers select appropriate imaging biomarkers among the various imaging protocols available and apply the selected type of imaging examination for each study in accordance with the academic purpose.

• The Journal of Pediatrics of Korean Medicine
• /
• v.38 no.1
• /
• pp.55-77
• /
• 2024

Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

• The Journal of Pediatrics of Korean Medicine
• /
• v.38 no.3
• /
• pp.13-28
• /
• 2024

Objectives This study aimed to analyze registrations in the World Health Organization International Clinical Trials Registry Platform for children and adolescents with tension-type headaches. Methods We collected and analyzed information on the basic and clinical characteristics of patients who participated in related clinical trials. All relevant clinical trials registered on or before July 2, 2024 were included in this study. Results Twenty clinical trials were selected for the analysis. Behavioral therapy was the most common intervention (60%), followed by drug, device, and manual therapies. The type of headache was the most frequently mentioned inclusion criteria, noted in 70% of the patients. Outcome indicators included headache frequency and intensity, quality of life, daily functioning, and mood. Conclusions Further clinical trials should require informed consent, an appropriate research design, suitable controls, and clear presentation of diagnostic criteria for more accurate and ethical studies.

• Korean Journal of Ichthyology
• /
• v.20 no.3
• /
• pp.173-178
• /
• 2008

The substrate preferences of juvenile black sea bass Centropristis striata (Linnaeus) was tested in a circular tank (1.5 m diameter${\times}$0.4 m deep) divided into two equal areas of oyster-related (oyster reef and whole oyster shell) and sand substrates. All trials were video taped for 20 min. Tapes were viewed on a monitor and locations of all fish recorded and timed with respect to substrate. $Mean{\pm}SE$ times on oyster shell were $18.1{\pm}2.0min$ (1-fish trial-1) and $17.5{\pm}1.7min$ (5-fish trial-1). $Mean{\pm}SE$ times on sand were $2.0{\pm}1.0min$ (1-fish trial-1) and $2.5{\pm}1.7min$ (5-fish trial-1). Black sea bass juveniles showed a significant preference for oyster reef and shell over sand substrate in single-fish trials (paired t-test, P<0.05) and also in five-fish trials (paired t-test, P<0.05). $Mean{\pm}SE$ times under oyster reefs were $16.6{\pm}2.0min$ in single-fish trials and $10.7{\pm}2.3min$ in five-fish trials. Mean numbers of movements among oyster reefs were $1.1{\pm}1.0$ in single-fish trials and $11.5{\pm}3.1$ in fivefish trials. Fish spent significantly less time under oyster reefs in five-fish trials, compared to single-fish trials (paired t-test, P<0.05) and they moved more frequently in five-fish trials than in single-fish trials (paired t-test, P<0.05). Significantly higher competition for a refuge in five-fish trials may induce less time under oyster reefs as well as frequent movement of black sea bass juveniles on shell substrate.

• Nutrition Research and Practice
• /
• v.8 no.6
• /
• pp.644-654
• /
• 2014

BACKGROUND/OBJECTIVES: Although preclinical studies suggest that garlic has potential preventive effects on cardiovascular disease (CVD) risk factors, clinical trials and reports from systematic reviews or meta-analyses present inconsistent results. The contradiction might be attributed to variations in the manufacturing process that can markedly influence the composition of garlic products. To investigate this issue further, we performed a meta-analysis of the effects of garlic powder on CVD risk factors. MATERIALS/METHODS: We searched PubMed, Cochrane, Science Direct and EMBASE through May 2014. A random-effects meta-analysis was performed on 22 trials reporting total cholesterol (TC), 17 trials reporting LDL cholesterol (LDL-C), 18 trials reporting HDL cholesterol (HDL-C), 4 trials reporting fasting blood glucose (FBG), 9 trials reporting systolic blood pressure (SBP) and 10 trials reporting diastolic blood pressure (DBP). RESULTS: The overall garlic powder intake significantly reduced blood TC and LDL-C by -0.41 mmol/L (95% confidence interval [CI], -0.69, -0.12) (-15.83 mg/dL [95% CI, -26.64, -4.63]) and -0.21 mmol/L (95% CI, -0.40, -0.03) (-8.11 mg/dL [95% CI, -15.44, -1.16]), respectively. The mean difference in the reduction of FBG levels was -0.96 mmol/L (95% CI, -1.91, -0.01) (-17.30 mg/dL [95% CI, -34.41, -0.18]). Evidence for SBP and DBP reduction in the garlic supplementation group was also demonstrated by decreases of -4.34 mmHg (95% CI, -8.38, -0.29) and -2.36 mmHg (95% CI, -4.56, -0.15), respectively. CONCLUSIONS: This meta-analysis provides consistent evidence that garlic powder intake reduces the CVD risk factors of TC, LDL-C, FBG and BP.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
• /
• v.29 no.2
• /
• pp.12-32
• /
• 2016

Objectives : The objective of this study is to develop the strategies of the psoriasis clinical trials guideline on Korean medicine by comparison between Clinical guidelines and domestic and foreign clinical trials papers of psoriasis on Korean medicine. Methods : This study is based on analysis of papers on Clinical trials guidelines, Clinical practice guideline and clinical trials about Korean medicine. The papers were searched from Pubmed, Medline, Oasis(Oriental Medicine Advanced Searching Integrated System), Korean Traditional Knowledge Portal and Google portal database. Results : A total 8 Clinical practice guidelines and 2 Clinical trials guidelines were found. Moreover, there were 15 foreign papers about clinical trials and 29 internal articles about case studies. They suggested the diagnostic strategy, classification, effective outcome measure, severity measure, precaution of combination therapy, precaution and treatment period of clinical trials, safety evaluation, patterns of Korean Medicine, clinical specific features on psoriasis.Conclusions : The criteria of every item to provide the clinical trials guideline using Korean medicine on psoriasis were developed by apply the results. If we accumulate the more clinical articles on Korean medicine, it will be great help to develop the reliable standard of that guideline.

• 대한예방의학회:학술대회논문집
• /
• 1994.02b
• /
• pp.265-269
• /
• 1994

A brief review is presented of the strengths and weaknesses of historical controls, data banks, and randomized trials in the evaluation of clinical treatment. Use of pre randomized versus postrandomized informed consent is discussed. Recommendations are made for the development of an appropriate clinical research strategy.

• 대한예방의학회:학술대회논문집
• /
• 1994.02b
• /
• pp.297-312
• /
• 1994

Over the last decade, considerable interest has focused on sample size estimation in the design of clinical trials. The resulting literature is scattered over many textbooks and journals. This paper presents these methods in a single review and comments on their application in practice.

• Proceedings of the PSK Conference
• /
• 2003.04a
• /
• pp.117.2-118
• /
• 2003

Sample size calculations plays an important role in a bioequivalence trials and is determined by considering power under the alternative hypothesis. The regulatory guideline recommends that $2{\times}2$ crossover design is conducted and raw data is log-transformed for statistical analysis. In this paper, we discuss the sample size calculation in $2{\times}2$ crossover design with the log-transformed data.