This website uses cookies to ensure you get the best experience. Learn more about DOAJ’s privacy policy.
Hide this message
Quick search
Close×BMJ Open (May 2025)
- Yan Zhang,
- Chenxi Li,
- Jiancheng Wang,
- Xu Zhou,
- Xiang Ye,
- Weifeng Zhu,
- Jianrong Chen,
- Lixia Yuan,
- Qiuyun Xue,
- Jieyi Zhou,
- Qihui Fan,
- Ruting Feng,
- Zhengfeng Li
Affiliations
- Yan Zhang
- Department of Endocrinology and Metabolism, The First Affiliated Hospital, Nanchang University Jiangxi Medical College, Nanchang, Jiangxi, China
- Chenxi Li
- Department of Diabetes and Endocrinology, The Affiliated Hospital of Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Jiancheng Wang
- Department of Endocrinology and Metabolism, The First Affiliated Hospital, Nanchang University Jiangxi Medical College, Nanchang, Jiangxi, China
- Xu Zhou
- Evidence-based Medicine Research Centre, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Xiang Ye
- Department of Diabetes and Endocrinology, The Affiliated Hospital of Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Weifeng Zhu
- Evidence-based Medicine Research Centre, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Jianrong Chen
- Department of Endocrinology and Metabolism, The First Affiliated Hospital, Nanchang University Jiangxi Medical College, Nanchang, Jiangxi, China
- Lixia Yuan
- Evidence-based Medicine Research Centre, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Qiuyun Xue
- Evidence-based Medicine Research Centre, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Jieyi Zhou
- Evidence-based Medicine Research Centre, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Qihui Fan
- Department of Diabetes and Endocrinology, The Affiliated Hospital of Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Ruting Feng
- Department of Diabetes and Endocrinology, The Affiliated Hospital of Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- Zhengfeng Li
- Department of Diabetes and Endocrinology, The Affiliated Hospital of Jiangxi University of Chinese Medicine, Nanchang, Jiangxi, China
- DOI
- https://doi.org/10.1136/bmjopen-2024-092050
- Journal volume & issue
- Vol. 15, no. 5
Abstract
Introduction The current pharmacological management of type 2 diabetes mellitus (T2DM) faces challenges such as low rates of optimal glycaemic control, high incidences of adverse drug reactions and suboptimal treatment compliance. Pueraria lobata radix (PLR), a medicinal and edible herb, has shown hypoglycaemic effects in animal models. However, existing clinical studies have only assessed the hypoglycaemic effect of PLR-containing herb formulas or PLR extract preparations. The aim of this study is to investigate the efficacy and safety of using PLR solely as an adjuvant therapy for T2DM.Methods and analysis This study is a multicentre, randomised, double-blind, placebo-controlled trial. 200 patients with T2DM will be randomly allocated to either the PLR group or the placebo group for a consecutive 12-week intervention. Regular visits will be conducted at weeks 4, 8 and 12, following the initiation of the study to evaluate the efficacy and safety of PLR. The primary outcome is the change in haemoglobin A1c (HbA1c) from baseline at week 12. Secondary outcomes include changes in HbA1c from baseline at weeks 4 and 8; the HbA1c response rate (< 7%), changes in fasting blood glucose, 2-hour blood glucose, fasting C-peptide, body mass index, severity of diabetes symptoms, quality of life from baseline at weeks 4, 8 and 12; and changes in blood lipid indicators at week 12. Safety outcomes include the incidences of total adverse events (AEs), serious AEs and PLR-related AEs.Ethics and dissemination The protocol has been approved by the Ethics Committees of the First Affiliated Hospital of Nanchang University (approval number: IIT[2024]LLS No.303) and the Affiliated Hospital of Jiangxi University of Chinese Medicine (approval number: JZFYLL2024006200087). We will disseminate the study findings through publications in peer-reviewed journals and conference presentations.Trial registration number ClinicalTrials.gov NCT06494683.
WeChat QR code
