Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 25, 2024
Open Peer Review Period: Nov 11, 2024 - Jan 6, 2025
Date Accepted: Jun 23, 2025
(closed for review but you can still tweet)
Registry of Stroke in Korean Medicine Hospital (RoS-KoMH): Protocol for a prospective, multicenter, observational study
ABSTRACT
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 actual KM treatment on stroke is essential.
Objective:
We aimed to collect and analyze the major clinical characteristics of stroke patients receiving KM treatment and investigate the effectiveness and safety of KM in the Korean population.
Methods:
The Registry of Stroke in the Korean Medicine Hospital (RoS-KoMH) is a prospective multicenter observational disease registry aimed at registering 500 sets of patients. Eligible adult patients diagnosed with cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage who visited four Korean medicine hospitals as outpatients or hospitalizations will be continuously registered in the electronic case report form. Baseline data at the first visit; Korean medicine treatment, rehabilitation therapy, and concomitant therapy during the visit; stroke evaluation every four 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 RoS-KoMH study is the first and largest multicenter prospective registry to record comprehensive data on KM treatment of stroke.
Conclusions:
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. Clinical Trial: This study was registered with the Clinical Research Information Service (http://cris.nih.go.kr; KCT0008494).
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