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| Current status of clinical trial registration of traditional Chinese medicine in the prevention and treatment of diabetic peripheral neuropathy：analysis and evaluation |
| Hits 391 Download times 245 Received:May 10, 2023 |
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| DOI
10.11656/j.issn.1672-1519.2023.09.10 |
| Key Words
diabetic peripheral neuropathy;traditional Chinese medicine;clinical trial;trial registration;analysis of the situation |
| Author Name | Affiliation | E-mail | | ZHANG Ying | Second Department of Internal Medicine, Tangshan Fengnan District Hospital of Traditional Chinese Medicine, Tangshan 063300, China | | | WANG Dongjun | School of Traditional Chinese Medicine, North China University of Science and Technology, Tangshan 063210, China
Key Laboratory of Integrated Traditional Chinese and Western Medicine for the Prevention and Treatment of Diabetes and Its Complications in Hebei Province, Tangshan 063210, China
Key Laboratory of Pharmacology of Traditional Chinese Medicine, Tangshan 063210, China
School of Public Health and Health Sciences, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | wangdongjuntcm@ncst.edu.cn | | JIA Hongwei | Second Department of Endocrinology, Tangshan Hospital of Traditional Chinese Medicine, Tangshan 063000, China | | | ZU Libin | Department of Geriatrics, Tangshan Hospital of Traditional Chinese Medicine, Tangshan 063000, China | | | XU Ling | Second Department of Internal Medicine, Tangshan Fengnan District Hospital of Traditional Chinese Medicine, Tangshan 063300, China | | | WANG Hongwu | School of Public Health and Health Sciences, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | |
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| Abstract
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| [Objective] To summarize the characteristics and development trend of traditional Chinese medicine（TCM） clinical trials on diabetic peripheral neuropathy（DPN） by searching the registration of TCM clinical trials at home and abroad，and to provide reference for the design of clinical trials on the prevention and treatment of DPN with TCM in the future. [Methods] The clinical trials of DPN were searched by computer in the international clinical trial registry（WHO ICTRP）. The search period is from August 31，2022. The DPN clinical trials were reviewed and the relevant data were extracted. Relevant clinical trial information was extracted，and the characteristics of DPN traditional Chinese medicine clinical trials（registration time，region and institution，design type，sample size，intervention measures，outcome indicators） were summarized. [Results] The 26 clinical trials on the prevention and treatment of DPN with traditional Chinese medicine were included. All clinical trials were registered in China and conducted in China. Registered units are distributed in 10 provincial-level administrative regions and 20 clinical registration institutions. The top three regions were Shanghai（8 items），Beijing（5 items） and Guang Zhou province（5 items）. The funding sources were provincial funds at most 8 projects，followed by 6 projects funded by academic research funds. The main research type was intervention study. Randomized parallel controlled trial was the main research design type of registered DPN. The 12 studies were preliminary trials，with a constituent ratio of 46.15%. The total sample size of the included clinical trials was 3 854，and the number of subjects in 13 clinical trials was less than 100. Five trials used acupuncture as an intervention；a total of 145 outcome indicators were registered and nerve conduction velocity was designed for 23 trials. [Conclusion] The registered number of clinical trials for the prevention and treatment of DPN by traditional Chinese medicine is relatively small on the whole，and the number is on the rise. Traditional Chinese medicine has obvious advantages in the prevention and treatment of DPN，but the design and registration of clinical trials need to be strengthened. |
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