Analysis of clinical study registration characteristics of traditional medicine for the treatment of type 2 diabetes mellitus based on the International Clinical Trials Registry Platform
Authors: Yang Sihong , Xiang Xinghua , Chai Jiaqi , Tan Yumeng , Xu Wenyuan , Kong Dezhao , Liang Ning , Yan Lijiao , Zhang Huifang , Wen Tiancai , Zhao Hui 
Published: July 2024

Objective:
To analyze clinical trials of traditional medicine (including Chinese herbal medicine and nonpharmacological therapies) for the treatment of type 2 diabetes mellitus (T2DM) registered in the International Clinical Trials Registry Platform (ICTRP), and accordingly to explore their clinical trial registration characteristics, development trend and intervention status, in an attempt to provide references for future research design, diagnosis and management of traditional Chinese medicine therapy for T2DM.

Methods:
The clinical trials related to Chinese herbal medicine and nonpharmacological therapies for treating T2DM were retrieved on the ICTRP online from the time of database construction to August 13, 2023, to analyze the time of registration, country and institution of the study, source of funding, type and design of the study, randomization and blinding methods, clinical staging, therapeutic measures, and main therapeutic effect indexes. Descriptive statistical analysis was performed using R4.3.0 and Excel software.

Results:
A total of 774 clinical trials for T2DM treatment were included, of which 127 were traditional herbal therapies and 647 were nonpharmacological therapies. The T2DM clinical trial registration institutions were distributed in 50 countries worldwide involving 15 clinical registration platforms, with the most registrations in Iran, China, and Australia, and the top 3 registration platforms were the Iranian Clinical Trial Registry, the Australian New Zealand Clinical Trials Registry, and the ICTRP. Universities (551, 71.19%) were the main funding sources. Intervention studies (750, 96.90%) were the primary study type, including randomized controlled trials (432, 56. 4%), and 225 studies mentioned the blinding method. A total of 530 (68.48%) with a sample size ≤100 were included. Study phases were predominantly phase 2 and phase 3 (108, 51.43%). The interventions of traditional medicine for T2DM were composed of Chinese herbal medicines (mainly ginseng and astragalus compound), nonpharmacological therapies (mainly exercise and diet therapies), and 2 or more comprehensive treatment regimes. According to the type of study design, the first 3 main therapeutic indexes were fasting blood glucose (286 times), glycated hemoglobin (282 times), and insulin resistance (120 times), and the top 3 secondary therapeutic indexes were body mass index (179 times), fasting blood glucose (175 times), and glycated hemoglobin (134 times).

Conclusion:
The study dissects the current status and trend of registration of clinical trials on traditional medicine for T2DM treatment. The number of trial registrations is on the rise year by year, and there are obvious geographical differences in the countries and platforms of registration. The trial design is mainly randomized controlled blind trials with a sample size of <100, and the main interventions are nonpharmacological therapies. Correct and standardized registration of clinical trials and timely reporting of study results are greatly important to facilitate the implementation of clinical trials, reduce publication bias, provide high-level diagnostic and therapeutic bases for clinical practice guidelines, and develop effective treatment strategies. This study is expected to help other scholars, health care professionals, patients, and the public to understand the latest research trends and hotspots in this field and provide certain references and inspirations for the future research design and clinical practice of traditional Chinese medicine in the treatment of T2DM.