• The Journal of Internal Korean Medicine
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• v.41 no.6
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• pp.959-966
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• 2020

Objectives: To examine the fundamental characteristics of interventional clinical trials registered in the CRIS (Clinical Research Information Service) database. Methods: We systematically analyzed the status of Korean medical interventions using the search function of the CRIS database. Results: From 2010 to January 2020, 267 Korean medicine-related clinical trials were registered with CRIS. The studies, which included many randomized trials (80.14%), focused primarily on demonstrating the effectiveness and safety of acupuncture and Korean herbal remedies. Most of these studies were government-sponsored and researcher-led clinical trials, but a few were company-sponsored trials. All trials were small and need improvement. Conclusion: This study reviews the current status of clinical trials in the field of Korean medicine and the basic data that can be used to create evidence-based Korean medicine.

• Journal of Society of Preventive Korean Medicine
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• v.24 no.2
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• pp.43-55
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• 2020

Objectives : The general and specific characteristics inherited in Korean traditional medicine research is to be identified and on the basis of this, the role of researchers, research institutes and government organizations is to be presented. Method : Analysis data targeted 399 cases of traditional medicine researches out of 696 cases, excluding overlapped 297 cases, that are relevanttokey-words, 'Oriental Medicine' and 'Herbal Prescription' registered in the National Institutes of Health Clinical Research Information Service(CRIS) as of 31 December, 2019. Including the regulation of the Ministry of Food and Drug Safety, research fund supporting, type of mediation, targeting disease and so forth, frequency analysis was carried out in order to confirm the general and specific characteristics of traditional medicine. Results : As a result of analyzing the data, researches of medicines(herbal medicines) and mediation(acupuncture, moxibustion) and were identified as the most and in the case of the targeting disease, it appeared in the order of targeting the research on musculoskeletal system and the healthy person.

• The Journal of Pediatrics of Korean Medicine
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• v.33 no.1
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• pp.17-33
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• 2019

Objectives The purpose of this study is to investigate the current status of registration of interventional studies focusing on children and adolescents in South Korea and the status of Korean medicine interventional studies through Clinical Research Information Service (CRIS). Methods CRIS was used to search interventional clinical researches which were registered from May, 2010 to October, 2018. Key words of 'child', 'children', 'adolescents', 'infant', 'toddler', 'elementary school student', 'middle and high school', 'middle school student', and 'high school student' were used. Results A total of 37 intervention clinical studies were selected. To identify the trends, years of registration in the CRIS, intervention types, disease categories, recruitment status, phase, institutions responsible for the research, consent, compensation and safety investigation were analyzed. Conclusions This study shows the current state of registration of interventional studies in children and adolescents in Korea. Since interventional studies in children and adolescents are essential for providing safe and effective treatment, further interventional studies, Korean medicine interventional studies and ethical considerations are needed.

• The Journal of Pediatrics of Korean Medicine
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• v.36 no.3
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• pp.1-18
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• 2022

Objectives The purpose of this study was to investigate the current status of interventional clinical trial registration for children with precocious puberty and to secure basic data for the design of clinical trials for traditional Korean medicine treatment of precocious puberty. Methods The following resources were used to search for data: Clinicaltrial.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and Clinical Research Information Service (CRIS), using the search terms, 'Precocious puberty', 'child'. All clinical trials which were registered as of June 2022 were used. Results For the intervention and clinical trial design, gonadotropin releasing hormone (GnRH) analog was reported in 41.7% of trials, and single group assignment was performed in 66.7% of the studies. Prior consent had not been reported in 50% of the studies. Tanner stage and GnRH stimulation tests were reported by multiple trials as inclusion criteria, and prior treatment experiences for trial drugs were reported as exclusion criteria. The peak serum concentration of luteinizing hormone following GnRH stimulation test was used as a primary outcome in 45.8% of clinical trials, and other growth-related indicators such as growth rate, height, and predicted adult height were also reported. Conclusions In consideration of the design, eligibility criteria, and outcome measurement of the existing clinical trials identified in this study, it should be referred to in the design of clinical trials for traditional Korean medicine treatment of precocious puberty.

• The Journal of Internal Korean Medicine
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• v.45 no.1
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• pp.1-10
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• 2024

Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

• Journal of Korean Medicine for Obesity Research
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• v.24 no.1
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• pp.87-93
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• 2024

Objectives: Obesity is a globally prevalent public health issue. Hence, there is a need for the development of safer and more effective anti-obesity drugs. Lythrum salicaria, a traditional medicinal herb used for centuries, has been reported to improve lipid metabolism and fat accumulation. It also has a low toxicity profile. Therefore, its potential as a functional ingredient in health functional foods needs to be evaluated. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 90 participants will be randomly assigned to either the experimental or control group. Each subject will orally receive L. salicaria extract (1,350 mg/day) (500 mg L. salicaria+850 mg lactose as vehicle) or lactose (1,350 mg/day) as a hard capsule formula for 84 days (12 weeks). The primary outcome will be body fat mass (kg), which will be assessed using dual-energy x-ray absorptiometry (DXA) (performed only at visits 2 and 4). Secondary outcomes include body mass index, body weight, waist-to-hip ratio, body fat percentage (%) measured using DXA, lean body mass (kg) measured using DXA (assessed only at visits 2 and 4), lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and calculated low-density lipoprotein cholesterol), free fatty acid, high sensitivity C-reactive protein, adiponectin, and leptin. Conclusions: This protocol will be implemented after approval of Institutional Review Board of Pusan National University Korean Medicine Hospital (approval number: PNUKHIRB-2022-08-002) and registration with the Korean National Clinical Research Information Service (CRIS) (CRIS-KCT0008060). The results of this trial will provide potential of L. salicaria as a new anti-obesity functional food with fat-reducing effects and low toxicity.

• Journal of Oriental Neuropsychiatry
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• v.29 no.4
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• pp.255-266
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• 2018

Objectives: The objective of this study was to evaluate the reliability and validity of Pattern Identifications Tool for Cognitive Disorders (PIT-C) and verify the correlation with other related scales. Methods: The study in this protocol is a single group, prospective, observational one. The subjects of the study were men and women between the ages of 45 and 85, diagnosed with neurocognitive disorders by Diagnostic and Statistical Manual of Mental Disorder (fifth Edition) criteria (n=60, Clinical Dementia Rating (CDR)=0.5, Korean Version of Montreal Cognitive Assessment $(MoCA-K){\leq}22$). The reliability of PIT-C was evaluated as test-retest and inter-rater reliability. And correlation between PIT-C and other related scales was also assessed. Results: This study was approved by the Institutional Review Board (IRB) of Dunsan Korean Medicine Hospital of Daejeon University and registered in the Clinical Research Information Service (CRIS), and was made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: The results of this study can be used to classify neurocognitive disorders as Korean medicine and PIT-C will be helpful tool for primary health care.

• The Journal of Pediatrics of Korean Medicine
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• v.35 no.2
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• pp.11-20
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• 2021

Objectives The purpose of the study is to evaluate the safety of the Allium Fistulosum extract in children and its effectiveness in height growth. Methods This study is randomized, double-blind, placebo-controlled trial. The participants are children between the 3rd and 25th percentiles in height, and between the ages of 5 and 12 years. They are randomly assigned to treatment group or control group. The treatment group will take 5 g (1 g as Allium Fistulosum extract) for 24 weeks, 1 time a day. The control group will take the 5 g (0 g as Allium Fistulosum extract) of placebo for 24 weeks, 1 time a day. The primary outcome is change in height, and the secondary outcomes are growth rate, height standard deviations, Insulin-like growth factor-1 (IGF-1), Insulin-like growth factor binding protein-3 (IGFBP-3), IGF1-1/IGFBP-3 ratio, growth hormone, bone age, osteocalcin, and Z-score for growth. Results This protocol has been approved by the institutional review board (IRB) of Daejeon Korean Medicine Hospital of Daejeon University (IRB No. DJDSKH-20-BM-15), and registered in the Clinical Research Information Service (CRIS) (Registry No. KCT0005981). Conclusions This study will provide clinical information about the effectiveness and safety of Allium Fistulosum extract in children for their growth.

• Journal of Pharmacopuncture
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• v.19 no.3
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• pp.197-206
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• 2016

Introduction: This study aims to investigate the effects of acupuncture stimulation on the radial artery's pressure pulse wave, along with various hemodynamic parameters, and to explore the possible underlying mechanism of pulse diagnosis in healthy participants in their twenties. Methods and analysis: This study is a prospective, single-arm, exploratory clinical study. A total of 25 healthy participants, without regard to gender, in their twenties will be recruited by physicians. Written informed consent will be obtained from all participants. The participants will receive acupuncture once at ST36 on both sides. The radial arterial pulse waves will be measured on the left arm of the subjects by using an applicable pulse tonometric device (KIOM-PAS). On the right arm (appearing twice), electrocardiogram (ECG), photoplethysmogram (PPG), respiration and cardiac output (CO) signals, will be measured using a physiological data acquisition system (Biopac module), while the velocity of blood flow, and the diameter and the depth of the blood vessel will be measured using an ultrasonogram machine on the right arm (appearing twice). All measurements will be conducted before, during, and after acupuncture. The primary outcome will be the spectral energy at high frequencies above 10 Hz ($SE_{10-30Hz}$) calculated from the KIOM-PAS device signal. Secondary outcomes will be various variables obtained from the KIOM-PAS device, ECG, PPG, impedance cardiography modules, and an ultrasonogram machine. Discussion: The results of this trial will provide information regarding the physiological and the hemodynamic mechanisms underlying acupuncture stimulation and clinical evidence for the influence of acupuncture on the pressure pulse wave in the radial artery. Ethics and dissemination: This study was approved by the Institutional Review Board (IRB) of Kyung Hee University's Oriental Medical Center, Seoul, Korea (KOMCIRB-150818-HR-030). The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: This trial was registered with the Clinical Research Information Service (CRIS) at the Korea National Institute of Health (NIH), Republic of Korea (KCT0001663), which is a registry in the World Health Organization's (WHO's) Registry Network.

• The Journal of Korean Medicine
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• v.42 no.4
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• pp.164-175
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• 2021

Objectives: The LI11 (Quchi) acupuncture point has always been included in the Seven acupoints for stroke; however, additional LI11 acupuncture research is needed. In this study, the effect of LI11 acupuncture on cerebral blood flow of the anterior cerebral arteries (ACA) and middle cerebral arteries (MCA) was investigated. Method: This study included 10 healthy young male subjects. Cerebral blood flow velocity and cerebrovascular reactivity were measured using transcranial Doppler sonography. Changes in hyperventilation-induced carbon dioxide (CO₂) reactivity and modified ACA and MCA blood flow velocity at 40 mmHg (CV40), blood pressure, and heart rate were observed before and after LI11 acupuncture treatment. Results: A statistically significant increase in contralateral anterior cerebral artery CO₂ reactivity (p=0.036) and decrease in contralateral middle cerebral artery CV40 (p=0.047) were observed. No significant difference in mean blood pressure was shown. A statistically significant increase in heart rate occurred after LI11 acupuncture; however, it was not clinically significant as there were negligible changes in the heart rhythm. Conclusions: LI11 acupuncture treatment could improve cerebral blood flow velocity. These results might be explained by regulating endothelium-dependent vessel dilation in the anterior cerebral artery region. Trial registration: This trial has been registered with Clinical Research Information Service, a service of the Korea Centers for Disease Control and Prevention: KCT0004494 (retrospectively registered). https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=15359