Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 11, 2025
Date Accepted: Mar 26, 2026
Safety of postpartum herbal medicine in primary care Korean medicine clinics: a prospective multicenter registry-based observational study (SAFEHERE-KM protocol)
ABSTRACT
Background:
Postpartum herbal medicine is widely used in East Asian health systems, including South Korea, where Korean medicine is part of national health care. However, safety data on real-world use remain limited. Understanding adverse events (AEs) associated with postpartum herbal medicine is essential to strengthen maternal health surveillance and inform public health policy.
Objective:
This study aims to establish a multicenter, registry-based platform to evaluate the safety of postpartum herbal medicine in Korean medicine clinics and to generate high-quality, real-world evidence on its clinical use.
Methods:
The Safety of Postpartum Herbal Medicine in Korean Medicine Clinics Registry Study is a prospective, multicenter, observational registry designed to assess AEs among postpartum women receiving herbal medicine. The study will recruit at least 1,000 postpartum patients from 15 Korean medicine clinics, mainly located in Seoul and the capital region, with additional sites in Daegu, Daejeon, and Jeju. Recruitment began in July 2024 and will continue through June 2027. The registry collects data on demographics, herbal prescriptions, concomitant medications, and AEs. AE causality will be evaluated using the WHO-Uppsala Monitoring Centre criteria and the Naranjo Algorithm. Data management follows standardized operating procedures and the STROBE reporting guideline.
Results:
Recruitment is ongoing at 15 Korean medicine clinics across South Korea. Data collection is in progress and will continue through June 2027. This protocol was prepared during data collection and prior to any data analysis. Study results are expected to be published in late 2027.
Conclusions:
This registry represents the first large-scale effort to monitor the safety of postpartum herbal medicine in Korean medicine clinics. The findings will enhance maternal health surveillance, strengthen pharmacovigilance for traditional medicine, and inform evidence-based maternal health policy in South Korea. Clinical Trial: The registry was registered with the Clinical Research Information Service (https://cris.nih.go.kr/cris/index/index.do) on June 20, 2024 (KCT0009552).
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