Clinical Evidence Profile of Oral Chinese Patent Ethnomedicines: Protocol for a Scoping Review and Evidence Map

Chinese patent ethnomedicines (CPEs), a form of traditional Chinese patent medicine, originate from the traditional medicines of ethnic minority groups and are widely used in clinical practice. However, existing evidence to support their application remains unclear. Therefore, to address this gap, this comprehensive scoping review will be performed to provide an overview of the available evidence on CPE preparations.

This review aims to provide the evidence profile for oral CPEs. This study will elucidate the current state of the evidence with respect to these medicines and identify research gaps. The detailed steps for conducting this review are outlined in this protocol. This review will contribute to a better understanding of CPEs.

This review will include clinical studies of CPEs irrespective of study design. The frameworks described by Arksey and O'Malley, Levac et al, and the Joanna Briggs Institute will be used to guide this scoping review. This review will involve six steps: (1) identifying the research question; (2) collecting information about CPEs from national related drug catalogs; (3) searching MEDLINE (via PubMed), Embase, Web of Science, Cochrane Library, and Chinese databases from inception to February 2025 to identify relevant publications; (4) screening the literature against the eligibility criteria; (5) extracting data using a predefined standardized data extraction form; and (6) summarizing, discussing, analyzing, and reporting the results. We will also present the results via data visualization techniques.

We will synthesize data on CPEs by conducting the scoping review, drawing the evidence maps, identifying the clinical characteristics of CPEs and how they relate to the adverse events, and highlighting the limitations and gaps in the literature. We expect to publish the results in 2027.

The data obtained through this review could inform future research involving CPEs.