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| Analysis of the current situation of clinical trial registration of traditional Chinese medicine for treating atherosclerosis of head and neck arteries |
| Hits 92 Download times 72 Received:April 22, 2026 |
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| DOI
10.11656/j.issn.1673-9043.2026.08.12 |
| Key Words
head and neck atherosclerosis;traditional Chinese medicine;clinical trial;registration and filing;analysis |
| Author Name | Affiliation | E-mail | | SHI Naixin | Department of Encephalopathy Ⅱ, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China | | | WU Shengxian | Department of Encephalopathy Ⅱ, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China | shengxianwu@126.com |
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| Abstract
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| [Objective] To characterize the registration patterns and methodological features of traditional Chinese medicine（TCM）-based clinical trials for the treatment of head and neck atherosclerosis，as registered in the Chinese Clinical Trial Registry，ClinicalTrials. gov，and the International Clinical Trials Registry Platform for Traditional Medicine. [Methods] TCM-related clinical trials targeting head and neck atherosclerosis were retrieved from the above databases，covering the period from database inception to May 2025. Relevant trial data were collected using Excel and SPSS 27.0 software，followed by descriptive summary and analysis. [Results] A total of 68 eligible trials were identified，registered across three primary platforms. These trials originated from 11 provincial level administrative regions and involved 73 distinct healthcare institutions. Of these，58 were prospectively registered； 59 reported having obtained formal ethical approval；41 committed to publicly disclosing statistical results；and 37 pledged to share individual participant-level data. The majority of the studies were interventional trials；specifically， 54 were randomized parallel controlled trials，of which 37 employed simple randomization and 31 implemented blinding. Interventions consisted primarily of empirical TCM formulas，hospital-prepared formulations，and Chinese patent medicines. Primary outcome measures centered on carotid ultrasound findings，circulating cytokine concentrations，and serum metabolic parameters. The registration quality of the included studies was suboptimal， with a mean completeness rate of 89.28%. [Conclusion] Currently，clinical trials investigating TCM for the prevention and treatment of head and neck atherosclerosis exhibit a favorable development trend. Nevertheless， improvements are warranted in three key areas：balanced geographical distribution，standardized trial design，and enhanced transparency of research information. |
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