Registry for vascular cognitive impairment treatment with traditional Chinese medicine (REVIEW-TCM): Rationale and design of a prospective, observational study

Background: Vascular cognitive impairment (VCI) is one of the most common diseases among the elderly. However, few effective drugs have been approved for VCI. Traditional Chinese medicine (TCM) has been used in dementia for thousands of years. Currently, there is limited high-quality evidence for the efficacy of TCM, and the specific characteristics of its effects and the appropriate patient populations for TCM therapies remain unclear. Herein, we aim to explore the effectiveness and safety of TCM by conducting a longitudinal, patient-centered study. Methods: REgistry for Vascular cognitive Impairment trEatment With Traditional Chinese Medicine (REVIEW-TCM) is a prospective, observational disease registry study. 1000 VCI patients at the Hunan Hospital of Integrated Traditional Chinese and Western Medicine will be recruited based on the following criteria: aged 18 years or older, Montreal Cognitive Assessment (MoCA) score <26, and Hachinski Ischemic Score (HIS)≥7. There is no strict limit on the intervention, and different TCM formulas will be focused. Cognition, activity of daily living, quality of life, mental, psychology, ZHENG of TCM, and burden of caregiver will be evaluated at admission, and 6, 12, 18, and 24 months. Meanwhile, biological tests and neuroimaging examination will be applied to further explore the mechanism of TCM. Especially, a mixed-methods embedded design will be applied by adopting quantitative and qualitative studies to explore patients-reported outcomes of TCM. Finally, propensity score matching will be adopted to analyze the effectiveness of TCM. Discussion: To the best of our knowledge, the REVIEW-TCM study is the first comprehensive, prospective, mixed-methods, registry-based study to evaluate TCM treatment in VCI, which will analyze the effectiveness and safety of TCM in the real world and explore population characteristics and subtypes of VCI suitable for TCM. Study registration: This study was registered on www.chictr.org.cn (ChiCTR2200064756). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ChiCTR2200064756 ### Clinical Protocols ### Funding Statement This research was supported by General project of Health Commission of Hunan Province (No.202218014505), General project of Hunan Administration of Traditional Chinese Medicine (No.D2022060), Hunan Province Clinical Medical Technology Innovation Guidance Project (No.2021SK51001), Natural Science Foundation of Hunan Province (No.2022JJ40241), Foundation of China Center for Evidence Based Traditional Chinese Medicine (No.2019XZZX-NB004), The National Key Research and Development Project (No.2018YFC1704904). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study protocol involving human participants has been reviewed and approved by Hunan Hospital of Integrated Traditional Chinese and Western Medicine, Changsha, China (No. [2022] 48). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.