A randomized, double-blind clinical trial of a herbal formulation (GlycaCare-II) for the management of type 2 diabetes in comparison with metformin

Diabetology & Metabolic Syndrome

Kalyanam Nagabhusahnam¹  Anju Majeed²  Shaji Paulose²  Lakshmi Mundkur²  Muhammed Majeed³ 

[1] Sabinsa Corporation, 20 Lake Drive, 08520, East Windsor, NJ, USA;Sami-Sabinsa Group Limited, 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, 560 058, Bangalore, Karnataka, India;Sami-Sabinsa Group Limited, 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, 560 058, Bangalore, Karnataka, India;Sabinsa Corporation, 20 Lake Drive, 08520, East Windsor, NJ, USA;

关键词: GlycaCare-II;    Metformin;    Glycosylated hemoglobin;    Fasting blood sugar and postprandial blood sugar;    Prediabetic;    Newly diagnosed diabetic and type 2 diabetes mellitus;   

DOI  :  10.1186/s13098-021-00746-0

来源: Springer

【 摘 要 】

BackgroundType 2 diabetes mellitus (T2DM) is a major public health concern with growing prevalence with multiple debilitating complications. GlycaCare-II is a proprietary herbal formulation supplement for T2DM containing extracts of Cinnamomum cassia, Momordica charantia, Pterocarpus marsupium, Gymnema sylvestre, Salacia reticulata, Eugenia jambolana, and a bioavailability enhancer piperine from Piper nigrum.ObjectiveThe antihyperglycemic potential of GlycaCare-II was compared against metformin in a double-blind study.DesignIt was a randomized, two-arm design on prediabetic (N = 29; 12 in metformin and 17 in GlycaCare-II arm, respectively) and newly diagnosed diabetic (N = 40; 16 in metformin and 24 in GlycaCare-II) patients for 120 days.Outcome measuresChanges in diabetic panel glycosylated hemoglobin (HbA1c), fasting blood sugar (FBS), and postprandial blood sugar (PBS) were the primary endpoints. Lipid profile, liver profile, thyroid-stimulating hormone, bilirubin and creatinine were the secondary endpoints.ResultTwice a day treatment for 120 days with GlycaCare-II led to a statistically significant change in HbA1c (p < 0.001), FBS (p < 0.001), PBS (p < 0.001) on both prediabetic and newly diagnosed diabetic patients. GlycaCare-II showed a similar potential as metformin in the treatment of T2DM. In the prediabetic group, both GlycaCare-II and metformin were comparable for all the hyperglycemic index parameters. In the case of newly diagnosed diabetic patients, GlycaCare-II showed a significantly better reduction for PBS (p = 0.026) as compared to metformin, while all other parameters in the diabetic panel were comparable. No adverse events were reported throughout the trial period.ConclusionThese results suggest that GlycaCare-II is effective in managing T2DM in both newly diagnosed diabetic and prediabetic patients.

【 授权许可】

CC BY