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Registry of Stroke in Korean Medicine Hospital (RoS-KoMH): Protocol for a Prospective, Multicenter, Observational
Han-Gyul Lee1, Woo-Sang Jung1, Seungwon Kwon1
1Kyung Hee University College of Korean Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.
Background:
Currently, conventional medicine for stroke treatment remains at a standstill. Korean medicine (KM), which is in high demand in Korea, has been shown to have a therapeutic effect on stroke; however, considering the absence of epidemiological and clinical characteristics of patients receiving KM for stroke in Korea and prospective, large-scale, long-term studies on the efficacy and safety of KM, the acquisition of data from KM treatments on stroke is essential.
Objective:
We aimed to collect and analyze data on the major clinical characteristics of patients with stroke receiving KM treatment and investigate the effectiveness and safety of KM in the Korean population.
Methods:
The Registry of Stroke in Korean Medicine Hospital (RoS-KoMH) is a prospective, multicenter, observational disease registry aimed at collecting data from 500 sets of patients at multiple timepoints. Eligible adult patients diagnosed with cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage who visited 4 KM hospitals as outpatients or inpatients will be continuously registered using the electronic case report form. Baseline data at the first visit; KM treatment, rehabilitation therapy, and concomitant therapy during the visit; stroke evaluation every 4 weeks after the first visit; laboratory findings at discharge or the last visit; and safety evaluation information after each acupuncture or pharmacopuncture treatment will be collected.
Results:
The study was funded on August 19, 2020, by the Ministry of Health and Welfare, Republic of Korea, and recruitment for the study started on November 3, 2021. As of September 25, 2024, a total of 410 participants have been recruited.
Conclusions:
The RoS-KoMH study is the first and largest multicenter, prospective registry to record comprehensive data on KM treatment of stroke. The results of this study will provide high-quality evidence on the current state of stroke treatment using KM in actual clinical practice, as well as treatment effectiveness and safety, and will consequently contribute to the promotion and standardization of therapeutic interventions for stroke in Korea.
Trial Registration:
Clinical Research Information Service KCT0008494; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=23999&search_page=L&search_lang=&class_yn=.
International Registered Report Identifier (Irrid):
DERR1-10.2196/67850.
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