The framework described by Arksey and O’Malley [13] and Levac et al [14] and the Joanna Briggs Institute scoping review methodology will be followed and adapted during this scoping review. This review will involve six steps: (1) identifying the research question; (2) collecting information about CPEs; (3) identifying relevant studies; (4) selecting studies; (5) extracting the data; and (6) summarizing, discussing, analyzing, and reporting the results. This scoping review will be reported in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines [16]. Additionally, this protocol was reported in accordance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines [17]. This review protocol was registered on the Open Science Framework platform.

This scoping review aims to provide an overview of the available evidence profile of CPEs and identify research gaps by focusing on clinical studies. Suggestions and revisions of the research question were requested from other related experimental or clinical research experts. The following questions will be addressed in our scoping review following consensus among the research team:

We selected CPEs from the Pharmacopoeia of the People’s Republic of China (2020 edition), National Reimbursement Drug List (2021 edition), and National Essential Medicines List (2018 edition). A total of 146 drugs were retrieved. After removing nonoral and repeated medicines, 105 CPEs remained, including Tibetan medicines (n=46, 43.8%), Mongolian medicines (n=35, 33.3%), Tibetan and Mongolian medicines (n=1, 1%), Uyghur medicines (n=18, 17.1%), Miao medicines (n=1, 1%), Yi medicines (n=1, 1%), Dai medicines (n=2, 1.9%), and Jingpo medicines (n=1, 1%). A total of 20 CPEs were included in any 2 of the aforementioned national drug catalogs. In particular, Liuwei Anxiao powder or capsules were included in the 3 national drug catalogs. Textbox 2 and Table S1 in Multimedia Appendix 1 provide basic information on the 105 CPEs included.

All identified references will be collated and uploaded into NoteExpress (version 3.4.0.8878), and duplicate records will be removed. The study selection process will be piloted independently by a reviewer using 20 studies to assess the interpretation of the eligibility criteria and the consistency of use. Following the pilot test, the eligibility criteria will be refined if necessary. During the formal process, the literature will be evaluated against the eligibility criteria; 2 trained reviewers independently and in duplicate will screen the titles and abstracts of the retrieved citations and review the full texts of studies considered potentially eligible. Disagreements will be resolved through discussion or, if necessary, adjudication from clinical experts who will be blinded to the trial results. When clarification of eligibility criteria is needed, we will contact the study authors and exclude studies by authors who do not respond. All the records that do not meet the inclusion criteria will be excluded, and the reasons for exclusion will be provided in an appendix. Multiple articles and reports from the same program will be treated as one with respect to the data extraction process and the presentation of research results. The details of the study selection process are shown in Figure 1.

Current ethnomedicine studies have focused on identifying classic, well-known prescriptions in ancient indigenous medicine texts and conducting textual research on them through the lens of classic literature rather than clinical research [26,27]. Therefore, research that focuses on analyzing the clinical characteristics of CPEs should be considered. To our knowledge, this scoping review is the first to systematically identify indigenous medicines endorsed by national authoritative drug catalogs and provide an overview of contemporary clinical research evidence. We will analyze the characteristics of previous clinical studies; explore the relationship between indigenous medicines and disorders based on contemporary research; and, ultimately, provide valuable insights and inspiration for future studies concerning CPEs.

As an integral aspect of TCM, ethnomedicine continues to be highly valuable in health care and has emerged as a complementary system to contemporary medical practices. Over time, through enduring application and refinement, it has led to the development of a variety of unique CPEs, which have played important roles in the prevention and treatment of chronic conditions, challenging illnesses, and endemic diseases in regions inhabited by ethnic minority groups. Many ethnic minority groups rely on CPEs as an adjuvant or alternative to conventional medical treatments.

However, ethnic medicine is not a mainstream medicine similar to Han Chinese medicine. The minority language, obscure medical theory system, unique processing methods, and wide regional differences have become barriers to the promotion and application of ethnic medicine. In particular, many CPEs contain toxic ingredients, such as zuotai (佐太), nux vomica (马钱子), aconite (乌头), aristolochic acid (马兜铃酸), and iron powder (铁粉). Among these, zuotai (佐太) is a preparation formed by the special processing of mercury by Tibetans. As an active ingredient, it has been used to treat cardiovascular disorders, liver disorders, and gastrointestinal disorders combined with Tibetan herbal medicine for 1300 years [28,29]. However, relevant studies have shown that zuotai can cause damage to the liver and kidney tissues of rats, especially long-term toxic effects on the spleen [30], which means that a greater number of medicines containing zuotai cannot be accepted and applied by a wider range of clinicians outside of minority groups. The same is true for other medicines containing toxic ingredients. Therefore, based on a scoping review of the existing literature, this study will conduct an in-depth analysis of the clinical characteristics of AEs using the collected clinical research evidence base. By identifying key clinical features associated with AEs, this study aims to enhance the safety profile and optimize the clinical treatment outcomes of CPEs.

At present, the exact mechanisms underlying the effects of most CPEs and their disease prevention effects have yet to be fully elucidated. Nonetheless, public enthusiasm for these treatments persists [8]. The natural source of these drugs makes them readily acceptable to the general population [31]. However, few clinical studies have examined the use of CPEs, and the existing evidence supporting their efficacy is inconclusive. Moreover, highly efficient and safe prescriptions have not been thoroughly explored, disseminated, or used. The knowledge regarding the use of ethnomedicine in clinical use and research of CPEs within modern medical practice is also unclear among most medical professionals [32,33]. These factors make it difficult to assess and recognize the potential value of CPEs or explore new avenues to enhance clinical practice. Consequently, there is an imperative need for a comprehensive review and analysis of relevant clinical studies. This effort is vital not only to protect and pass down the knowledge of traditional CPE use but also to provide guidance for ongoing research and development in the field of ethnomedicine.

In the future, we will conduct targeted analyses (eg, systematic reviews or network meta-analyses) to scientifically evaluate the efficacy and safety of CPEs. Additionally, we will perform comparative analyses between similar medicinal products to determine the specific therapeutic advantages of CPEs. To further highlight the characteristics and advantages of CPEs and the role of ethnic Chinese medicine in the health care field, the following suggestions are proposed. The first is to cultivate researchers with the cross-subject background of TCM, ethnic medicine, and Chinese medical literature, among other related fields, to find the intersection of the 2 theories (TCM and Chinese ethnomedicine) from the perspective of historical traceability and interpret and transform the theory of ethnic medicine into the concept understood in Han Chinese medicine to deeply master the theory of ethnic medicine and promote the complementarity of the discipline. The second suggestion is to select the priority disorders that classic CPEs treat, identify the disease stage in which these therapies demonstrate comparative therapeutic advantages, and precisely establish complementary advantages in conjunction with Han Chinese medicine. Third, given that ethnic medicines contain many toxic components, with the patient’s informed consent and full consideration of their wishes, pilot studies of advantageous ethnic medicines can be conducted for end-stage patients with critical diseases such as cancer or rare diseases that lack effective therapy in modern medicine. The fourth suggestion is to promote the localization of ethnic medicine production; compare the processing technology of ethnic drugs with that of modern processing methods; carry out the interdisciplinary integration of research methodologies across different medical fields; and, therefore, further understand the value of the processing method of ethnic medicines to increase their acceptability and dissemination.

Developing a protocol before conducting a scoping review is beneficial for several reasons [17]. First, protocols help predict potential challenges that may arise during the review. Second, protocols prevent arbitrary decisions related to the inclusion criteria and the data extraction process. Third, protocols mitigate the risk of selective reporting. Fourth, protocols minimize the likelihood of study duplication. For this study, we preliminarily identified some indigenous medicines and will retrieve relevant literature, screen the studies, and extract the data.

This protocol describes an exploratory research framework for secondary literature regarding CPEs in which the evidence will be evaluated via comparative analysis rather than quantitative synthesis. Furthermore, this review will only provide a clinical overview of the CPEs listed in Chinese national authoritative documents and will not include other medicines reported elsewhere.

This paper presents a comprehensive scoping review protocol aimed at evaluating the clinical evidence profile of oral CPEs. The review will systematically identify, describe, and map the evidence related to the application of CPEs in clinical practice with a focus on addressing the current lack of clear evidence and identifying research gaps. The findings will contribute to a better understanding of CPEs and provide valuable insights for future research and development in the field of ethnomedicine.