Abstract
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.
Highlights
Type 2 diabetes mellitus (T2DM) is a persistent hyperglycemic disorder, wherein blood glucose levels are above the normal values
No adverse events were reported throughout the trial period. These results suggest that GlycaCare-II is effective in managing T2DM in both newly diagnosed diabetic and prediabetic patients
The HbA1c level reduced to 6.52 ± 0.19% (p < 0.001) for GlycaCare-II and 6.53 ± 0.26% (p = 0.004) for metformin
Summary
Type 2 diabetes mellitus (T2DM) is a persistent hyperglycemic disorder, wherein blood glucose levels are above the normal values. It is characterized by an increase in oxidative stress [1, 2]. The International Diabetes Federation estimated that the global diabetes prevalence in 2019 is 463 million people, rising to 578 million by 2030 and 700 million by 2045 [4] Hyperglycemia causes both macrovascular (coronary artery disease, peripheral arterial disease, and stroke) and microvascular complications (diabetic nephropathy, neuropathy, and retinopathy) [5]. Type 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
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