Yuyang Hu,* Zhili Wang,* Kaiwen Ni, Junchao Yang

Department of The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, Zhejiang, 310006, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Junchao Yang, Department of The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, Zhejiang, 310006, People’s Republic of China, Tel +86 13858036093, Email yangjunchaozj@zcmu.edu.cn

Abstract: Randomized controlled trials (RCTs), as the highest level of evidence and the gold standard in clinical research, occupy a central position in modern medical research due to their stringent variable control and high internal validity. However, their vacuum-like research environment and standardized treatment approaches face significant challenges in traditional Chinese medicine (TCM), which emphasizes Treatment Tailored to Individual and Treatment Based on Syndrome Differentiation, focusing on personalized treatment according to a patient’s constitution, age, gender, and lifestyle, and diagnosis based on specific syndromes. This approach lacks systematic modern clinical research and unified standards, conflicting with RCTs’ standardized design, thus limiting TCM trials and posing serious challenges to its modernization and internationalization. This study systematically collected and categorized data on the registration status, study type, design, interventions and control measures, research objectives, primary outcome measures of registered trials by searching the ClinicalTrials.gov using TCM-related keywords. It reveals the current status and distribution patterns of TCM clinical registration trials. Evidence suggests that TCM clinical trials urgently need to seek a balance between standardized research and individualized treatment to address the limitations of RCTs in the TCM field, like implementation difficulties and the neglect of individual differences. To address this, the paper proposes an innovative research framework centered on pragmatic RCTs, highlighting randomization based on patient preferences to gather real-world evidence. Additionally, it suggests constructing a multidimensional core information set for standardized diagnosis of TCM syndromes by integrating disease and syndrome data to enhance diagnostic scientificity and increase the credibility and international acceptance of TCM clinical trials. The introduction of this framework effectively integrates the traditional characteristics of TCM with modern scientific methods, providing essential theoretical support and innovative solutions for the design and implementation of TCM clinical research, thereby enhancing TCM’s role in global health.

Keywords: traditional Chinese medicine, TCM, clinical research, randomized controlled trials, RCT, TCM clinical trials, personalized treatment, standardized research