Efficacy and Safety of an Ayurveda Herbal Formulation in Uncomplicated Type 2 Diabetes mellitus.

BackgroundMedicinal plants and herbal preparations have been used in Ayurveda medicine to treat diabetes for centuries. Link Gluconorm (LG) is a standardized solid formulation comprising seven medicinal herbs that have been used as herbal ingredients in Ayurveda for treating type 2 diabetes mellitus (T2DM). This study evaluated the efficacy and safety of the solid form of LG, and its effect on the quality of life (QoL) in T2DM patients.Materials and methodsAn observational study was conducted on 37 newly diagnosed uncomplicated T2DM patients aged between 35 and 65 years, whose fasting blood glucose levels ranged between 110 and 160 mg/dL. They were being treated for diabetes using the LG herbal formulation as the sole treatment. Laboratory tests for assessing glycemic control and safety were done at baseline and repeated at 4-weekly intervals for 24-weeks. A validated diabetes-specific QoL inventory was administered every 2 weeks.ResultsThe mean age was 48 ± 9y, and the mean body mass index was 25.0 ± 4.4 kg/m and 25.2 ± 4.2 kg/m for females and males, respectively. Statistically significant reductions in mean fasting blood glucose (153.85 mg/dL ± 15.62 to 129.01 mg/dL ± 12.88, p = 0.006), postprandial blood glucose (191.27 mg/dL ± 21.40 to 140.72 mg/dL ± 8.92, p < 0.001), glycosylated hemoglobin (8.51%±0.44 to 7.43%±0.40, p < 0.001) and improved QoL scores (1.93 ± 0.22 to 1.55 ± 0.08, p < 0.01) were observed at 24 weeks. There were no adverse changes in the hematological, liver and renal function safety parameters assessed using laboratory investigations. No adverse events or hypoglycemia were reported.ConclusionsThe polyherbal formulation LG significantly improved the QoL and glycaemic parameters and appeared safe after 24 weeks of treatment. Due to the small sample size, unblinded nature of this preliminary study, and the lack of a control arm, a randomized double-blinded controlled clinical trial on a larger group of patients is recommended.