临床传统医学和药理学（英文）2026，Vol.7Issue(2)：33-48,16.DOI:10.1016/j.ctmp.2026.200286
匙羹藤(Gymnema sylvestre)联合镁与维生素D3对2型糖尿病患者血糖控制效果的疗效评价:一项前瞻性、开放标签、单臂临床研究及潜在机制探讨
Assessment of Gymnema sylvestre in association with magnesium and vitamin D3 on glycemic control in type 2 diabetes mellitus:A prospective,open-label,single-arm study with possible mechanistic insights
摘要
Abstract
Background:Type 2 Diabetes Mellitus(T2DM)is a chronic metabolic disorder characterized by insulin resistance and impaired glucose regulation.Unequal access to healthcare products,services,and reliable information com-plicates effective disease management,underscoring the urgent need for affordable,supportive interventions.In this context,adjunctive strategies,i.e.,nutraceutical formulations,are gaining interest for their potential to enhance insulin sensitivity and support overall diabetes management. Objective:This study aimed to evaluate the safety and efficacy of a nutraceutical formulation in individuals with T2DM.Study determines metabolic parameters such as fasting plasma glucose(FPG),postprandial plasma glucose(PPG),and glycated hemoglobin(HbA1c)levels including quality-of-life(QoL)and diabetes-related symptom management. Methods:This prospective,open-label study enrolled male and female participants aged 18-65 years with es-tablished T2DM.Participants received two capsules of the formulation daily for 12 weeks in addition to their standard antidiabetic therapy.Data were analysed with statistically tools. The study was conducted in accordance with the Declaration of Helsinki(DoH)and International Council for Harmonisation-Good Clinical Practice(ICH-GCP)guidelines,with approval from the Sai Krupa Hospital Institutional Ethics Committee(Ref.No.ECR/1350/Inst/MH/2020;dated June 07,2024)and registration in the Clinical Trials Registry of India(CTRI)(URL:https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTA1NTc4&Enc=&userName=,Reg.No.:CTRI/2024/06/068889;dated June 06,2024). Results:Thirty participants completed the study without any reported adverse events.At Week 12,significant reductions were observed in HbA1c,FPG,and PPG levels compared with the baseline.Participants also demon-strated significant improvements in QoL scores and a reduction in sugar cravings. Conclusion:The findings indicate that the combination of magnesium,vitamin D3 and a standardized leaf extract of Gymnema sylvestre is safe and leads to an improvement in glycemic control and overall metabolic well-being in individuals with T2DM.By improving insulin sensitivity and reducing sugar cravings,this formulation shows promise as an affordable and well-tolerated adjunct to conventional diabetes management strategies.关键词
糖尿病/糖化血红蛋白/嗜甜/胰岛素/营养保健品/草本植物Key words
Diabetes/HbA1c/Sugar craving/Insulin/Nutraceutical/Herbs引用本文复制引用
Neelesh Kumar Nema,Smitha Sarojam,Keerthana K,Chandu Devanpally,Varghese Jacob..匙羹藤(Gymnema sylvestre)联合镁与维生素D3对2型糖尿病患者血糖控制效果的疗效评价:一项前瞻性、开放标签、单臂临床研究及潜在机制探讨[J].临床传统医学和药理学（英文）,2026,7(2):33-48,16.基金项目
Synthite Industries Pvt.Ltd.,the manufacturer of Gymne-Mag D®,provided financial support for the conduct of this clinical trial.The study was operationally managed by Ardent Clinical Research Services Pvt.Ltd.,which functioned as the designated clinical research organization.No governmental or public-sector funding was received for the design,execution,analysis,or reporting of this study.The sponsors had no un-due influence on the scientific integrity or interpretation of the study outcomes. （）
