[1] U PeiliRONG JieYANG YifanZHANG Junhua?GUO ChenglianZHANG HuiYAN Yongmei,.Analysis of the Current Status of Clinical Trial Registration for Traditional Chinese Medicine in the Prevention and Treatment of Parkinson’s Disease in China [J]. Journal of Shaanxi University of Traditional Chinese Medicine, 2024, (01): 7-13. [doi: 10.13424/j.cnki.jsctcm.2024.01.002]
Analysis of the Current Status of Clinical Trial Registration for Traditional Chinese Medicine in the Prevention and Treatment of Parkinson’s Disease in China
- Article number:
- 2096-1340(2024)01-0007-07
- Keywords:
- Key words： Parkinsons disease; Traditional Chinese medicine treatment; Clinical trials; China Clinical Trial Registration Center
- ZTFLH:
- R277.7
- Code:
- A
- Abstract:
- Abstract： Objective To explore the characteristics and development trends of clinical trials of traditional Chinese medicine related to Parkinsons disease in China registered at the Chinese Clinical Trial Registry (ChiCRT).Methods Retrieve clinical trials related to the prevention and treatment of Parkinsons disease using traditional Chinese medicine registered in the ChiCRT database.The search was conducted from the database establishment date to June 10,2023.Access was used to establish the database to obtain relevant data,and Excel was used to summarize and analyze the data,exploring its clinical trial characteristics.Results The results included a total of 62 clinical trials of traditional Chinese medicine related to Parkinsons disease in China,involving 14 provinciallevel administrative regions and 41 clinical trial units (institutions).The top three registered regions are Shanghai (16,25.8%),Beijing (13,21.0%),and Guangdong (9,14.5%),accounting for a total of 61.3%.Among the experimental institutions,Longhua Hospital affiliated with Shanghai University of Traditional Chinese Medicine has the highest number of registrations,with 5 items accounting for 8.0%.The top ranked source of funding is local financial assistance;Next are unit funding and national financial support.The research type is mainly intervention research,with a total of 58 items (93.5%).The research method adopts random method in 56 items (96.6%) and blind method in 23 items (37.0%).Interventions include traditional Chinese medicine,traditional Chinese patent medicines and simple preparations,acupuncture and moxibustion and traditional exercises.Conclusion The number of registered clinical trials of traditional Chinese medicine for the treatment of Parkinsons disease in China has been increasing year by year,and the awareness of standardization in clinical trials among researchers is constantly improving.However,there are problems such as insufficient understanding of clinical trial registration for traditional Chinese medicine in the prevention and treatment of Parkinsons disease,limited clinical trials to single centers,uneven distribution of regions and institutions,low quality of RCT research,lack of standardization in clinical trial design,need to strengthen standard operating procedures and quality control,and nonstandard clinical trial research reports.Traditional Chinese medicine has various methods for treating Parkinsons disease and significant therapeutic effects.Therefore,it is recommended that researchers enhance their research awareness,optimize design plans,and attach importance to the standardized management of clinical trials.
References:
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Memo
基金项目：国家中医药管理局中医药科学技术研究专项课题（GZY-KJS-2021-001）；陕西省重点研发计划项目（2020ZDLSF05-14）；陕西省中医药管理局中西医结合临床协作创新项目（2020-ZXY-002）；陕西中医药大学附属医院科研课题（2020LCJD003；2020LCJD007）