Jin Hanbit, Lee Do-Eun, Cheong Moon Joo, Jun Hyungsun, Eom Taena, Jeon Seojae, Kang Dong-Hoon, KooK Hye-Jeong, Lee Daeun, Jung In Chul, Leem Jungtae, Kang Hyung Won
Department of Diagnostics, College of Korean Medicine, Wonkwang University, Iksan, Republic of Korea.
Department of Korean Neuropsychiatry Medicine, College of Korean Medicine, Wonkwang University, Iksan, Republic of Korea.
PLoS One. 2025 May 15;20(5):e0323170. doi: 10.1371/journal.pone.0323170. eCollection 2025.
Despite the rapid increase in dementia and cognitive impairment incidence in Korea, research on integrative treatment for cognitive impairment using Korean medicine (KM) is still in its infancy. Thus, prospective studies with systematic data collection are required. This study aims to systematically collect and explore data from patients with dementia and mild cognitive impairment (MCI) who visit KM institutions. The data collected will include the participants' baseline characteristics, cognitive impairment severity, KM diagnosis and treatment status, as well as the factors influencing their choice of integrative medical treatment.
This registry study will be conducted from the time of registration in 2024 until December 31, 2029, at Wonkwang University Korean Medicine Hospital, Wonkwang University Jangheung Integrated Medical Hospital, and Daejeon Korean Medicine Hospital of Daejeon University. Approximately 300 participants will be enrolled and visit the hospital annually for data collection. The collected data will include sociodemographic characteristics, laboratory tests, medical device inspections, long-term care information, and various questionnaires related to dementia and cognitive impairment. No predefined interventions or restrictions on treatment will be imposed. Standard and KM treatments for cognitive impairment, including combination therapies, are permitted. As a registry study, the purpose is to investigate the participants' characteristics as outlined in the study objectives, including severity, KM diagnosis and interventions, and clinical outcomes. This epidemiological study is designed to include additional statistical analyses in response to research questions that emerge over time.
This study represents a pioneering effort in the KM field establishing the first registry of its kind focusing on dementia and MCI. This study aims to identify the characteristics of patients with dementia and MCI who visit KM institutions, explore the factors influencing KM treatment, and observe clinical outcomes according to KM pattern identification, providing evidence based on real-world data.
尽管韩国痴呆症和认知障碍的发病率迅速上升，但针对使用韩医学（KM）进行认知障碍综合治疗的研究仍处于起步阶段。因此，需要进行有系统数据收集的前瞻性研究。本研究旨在系统收集和探索就诊于韩医学机构的痴呆症和轻度认知障碍（MCI）患者的数据。收集的数据将包括参与者的基线特征、认知障碍严重程度、韩医学诊断和治疗状况，以及影响他们选择综合医疗治疗的因素。
这项登记研究将于2024年登记时开始，持续至2029年12月31日，在圆光大学韩医院、圆光大学长兴韩医综合医院和大田大学大田韩医院进行。约300名参与者将被纳入研究，并每年到医院进行数据收集。收集的数据将包括社会人口统计学特征、实验室检查、医疗器械检查、长期护理信息，以及与痴呆症和认知障碍相关的各种问卷。不对治疗施加预先定义的干预措施或限制。允许采用包括联合治疗在内的认知障碍的标准治疗和韩医学治疗。作为一项登记研究，其目的是调查研究目标中概述的参与者特征，包括严重程度、韩医学诊断和干预措施以及临床结果。这项流行病学研究旨在根据随时间出现的研究问题进行额外的统计分析。
本研究是韩医学领域的一项开创性工作，建立了首个专注于痴呆症和MCI的此类登记册。本研究旨在确定就诊于韩医学机构的痴呆症和MCI患者的特征，探索影响韩医学治疗的因素，并根据韩医学辨证观察临床结果，提供基于真实世界数据的证据。
