Analysis on the current situation of clinical trials registration of Chinese materia medica in China
10.3760/cma.j.cn115398-20250415-00209
- VernacularTitle:中国中药药物临床试验注册现状分析
- Author:
Jing HUANG
1
;
Bin FENG
;
Shuibing LIU
;
Hongxu YANG
;
Huan ZHANG
;
Lifei CHENG
;
Yihuan LIU
;
Weigang WANG
;
Jia JU
Author Information
1. 口颌系统重建与再生全国重点实验室 国家口腔疾病临床医学研究中心 陕西省口腔生物工程技术研究中心 空军军医大学口腔医院药剂科，西安 710032
- Keywords:
Traditional Chinese Medicine;
Clinical Trials;
Registered;
Current Situation;
China
- From:
International Journal of Traditional Chinese Medicine
2025;47(10):1454-1460
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the current status of clinical trials of Chinese materia medica for the purpose of registration in China; To provide reference for the research and development of new TCM drugs.Methods:Clinical trials of Chinese materia medica/natural medicine registered in Drug Clinical Trial Registration and Information Disclosure Platform were retrieved from inception to December 31, 2024. Excel 2019 software was used to input and analyze the data such as the number of registered clinical trials, date of first publication, study status, field of indication, trial phases, sponsors, group leader, and design types.Results:A total of 1 137 Chinese materia medica clinical trials had been registered, accounting for 4.12% of the total number registered on the platform. Phase Ⅱ clinical trials accounted for the highest proportion (58.8%), and 99.7% of clinical trials conducted domestically. The sponsors were predominantly domestically pharmaceutical enterprises. These 1 137 clinical trials of Chinese materia medica clinical trials involved 752 drug categories, 28 dosage forms, and 796 varieties (the same class of drugs had different drug dosage forms), with capsules being the most common. The indications primarily focused on respiratory, digestive, cardio-cerebrovascular, neuropsychiatric, gynecological diseases. The group leader of clinical trials was distributed in 28 provinces, among which the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine as the group leader, undertook the most clinical trials of TCM. 89.9% of the clinical trials adopted the randomized controlled trial design, and only 31.9% of the clinical trials purchased insurance for the subjects.Conclusion:The research and development of new TCM drugs has entered a phase of vigorous development. Further efforts are still needed in establishing systematic guidelines for Chinese materia medica clinical trials, accelerating the internationalization of TCM, exploring innovative dosage forms and indications, and strengthening the protection of participants' rights.
