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. 2025 Jul 22;25(1):282.
doi: 10.1186/s12906-025-05030-6.

Korean medicine registry for allergic rhinitis in real-world settings (KOREA-R): a multicenter registry protocol

Boram Lee  1 , Gyu Tae Chang  2 , Hyelim Lee  3 , Sun Haeng Lee  4 , Tae Hwan Kim  4 , Mi Mi Ko  1 , Sumin Seo  1 , Bok-Nam Seo  1 , Su Eun Lim  1 , Mi Ju Son  5
Affiliations

Korean medicine registry for allergic rhinitis in real-world settings (KOREA-R): a multicenter registry protocol

Boram Lee et al. BMC Complement Med Ther. .

Abstract

Background: Allergic rhinitis is a prevalent immune disorder with a significant impact on quality of life and socioeconomic burden. Korean Medicine treatments such as herbal medicine and acupuncture are widely utilized for allergic rhinitis due to clinical effectiveness and patient preferences. In particular, herbal decoctions, a key component of Korean Medicine treatment for allergic rhinitis, offer personalized treatment but pose challenges for randomized controlled trials due to the difficulty of placebo development. This study aims to establish a registry utilizing real-world data (RWD) on Korean Medicine treatment for allergic rhinitis, focusing on the effectiveness, safety, and cost-effectiveness of herbal decoctions in clinical practice.

Methods: The KOrean medicine REgistry for Allergic rhinitis in Real-world settings (KOREA-R) aims to enroll 400 patients with allergic rhinitis receiving Korean Medicine treatment at two Korean Medicine hospitals from February 2025 to June 2028. Patients will be examined in three visits at 2-week intervals, followed by two additional online follow-ups at 6 and 12 months after week 4. RWD on symptom severity, quality of life, treatment administration and compliance, adverse events, and laboratory blood tests will be collected. Participation is voluntary, with no restrictions on treatment types or dosages. Statistical analyses, including propensity score matching and difference-in-difference, will be used to evaluate the effectiveness, safety, and cost-effectiveness of Korean Medicine treatment, particularly herbal decoctions. Data management ensures confidentiality and quality through a validated electronic data capture system and regular monitoring.

Conclusion: The findings of KOREA-R will provide insights into the effectiveness and safety of Korean Medicine treatment for allergic rhinitis, with a focus on herbal decoctions tailored to individual patient symptoms and pattern identifications. Additionally, by systematically collecting RWD for multidimensional analysis, KOREA-R will offer valuable information on the cost-utility and cost-effectiveness of herbal decoctions for both patients and healthcare policymakers.

Study registration: Clinical Research Information Service, KCT0010133 (Registration date: January 13, 2025).

Keywords: Allergic rhinitis; Herbal Decoction; Herbal medicine; Korean medicine; Registry.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol was approved by the IRBs of Kyung Hee University Korean Medicine Hospital (KOMCIRB 2024-11-001) and Daejeon Korean Medicine Hospital of Daejeon University (DJDSKH-24-BM-12) in Korea. If the protocol is amended, it will be implemented after receiving approval from the IRBs. The current protocol version is 1.1 (December 6, 2024), and the recruitment of participants has not begun as of this manuscript submission. Written informed consent will be obtained from all participants or their legal representatives before study enrollment. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

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