Analysis on current status of registered clinical trials of TCM prevention and treatment for malignant tumors
10.3760/cma.j.cn115398-20241117-00206
- VernacularTitle:中医药防治恶性肿瘤临床研究注册现状分析
- Author:
Qianqian BU
1
;
Xuechen GENG
;
Changshun ZHOU
;
Guannan ZHANG
;
Liu LI
;
Yanmei LIU
;
Ling LI
;
Haibo CHENG
Author Information
1. 南京中医药大学第一临床医学院2022级博士研究生，南京 210003
- Keywords:
Medicine, Chinese Traditional;
Cancer;
Clinical research;
Clinical trial registration
- From:
International Journal of Traditional Chinese Medicine
2025;47(7):985-991
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the current status of clinical research registration on TCM prevention and treatment of malignant tumors in the Chinese Clinical Trail Registry (ChiCTR); To summarize its characteristics and shortcomings.Methods:Clinical studies on the TCM prevention and treatment for malignant tumors registered from the establishment of ChiCTR database to July 15, 2024 were retrieved. Excel 2019 software was used to sort out the data, including basic research information (registration time, registration number status, registration title, test organizer, research implementation location, etc.), design scheme (disease type, research type, intervention measures, sample size, blind method, etc.), research funding or material sources, as well as other information such as human specimen collection and recruitment of research objects. SPSS 27.0 software was used for frequency statistics.Results:A total of 891 registered studies were included, including 783 interventional studies and 108 observational studies; the areas with a large number of registrations were mainly Shanghai, Beijing, Guangdong Province, etc. ; the research funds mainly came from local finance; a total of 46 tumor diseases were involved in the study, with the largest number of lung cancer (209 items), followed by tumor-related syndromes (155 items), colorectal cancer (148 items), and breast cancer (136 items); the type of research design was mainly random parallel control; the main intervention measures were TCM decoction or herbal decoction pieces (373 items), and the dosage form was mostly decoction (216 items), followed by granules (94 items); single-blind or double-blind design was used in 217 registered trials; 663 registration trials involved the collection of human samples.Conclusions:The number of clinical research registrations on the TCM prevention and treatment for malignant tumors is increasing day by day. The shortcomings such as insufficient standardization of research design and lack of research transparency still exists. In the future, TCM researchers need to strengthen cooperation with international traditional medicine clinical trial registry, giving full play to the leading role of standardization of TCM trials, and using registration as a starting point to improve the quality of clinical research.
