Clinical Observation Of Efficacy And Safety Of Sancai Powder For The Treatment Of Newly Diagnosed Type 2 Diabetes Mellitus (Type Of Yin Deficiency And Heat)

Objective:To observe the efficacy and safety of Sancai powder for the treatment of Newly Diagnosed type 2 diabetes mellitus (Type of Yin deficiency and heat).Methods:Total 80 subjects were recruited and randomly divided into the trial group and the control group in a multicenter, randomized, controlled study.40 patients in trial group were treated with Sancai powder and 40 patients in control group were treated with metformin tablets.Basic therapy were operated among all patients.At 12 weeks after treatment, we observed the change of indexes including blood glucose(FPG,2hPG), glycosylated hemoglobin(HbAlc), Body weight, body mass index (BMI), Waistline,fasting insulin (FINS), HOMA insulin resistance (HOMA-IR), Insulin sensitivity index (ISI), HOMA islet beta cell function index (HOMA-beta), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C),and the clinical syndrome,also the blood routine, urine and stool routine, liver and kidney function, electrocardiogram (ECG) and other safety indicators, At the same time, the adverse reactions and their incidence and severity were observed. And comprehensive efficacious as well as safety were evaluated.Results:1. HbA1c、FBG and 2hPG levels were significantly decreased (P<0.01) in each group after intervention;The effect is identical with metformin. 2.Weight,BMI, Waistline were decreased,but the difference was not statistically significance(P>0.05) in each group after treatment.3. Ln(HOMA-beta), difference was statistically significance (P<0.05) in both groups after intervention and the differences between the two groups were of no significance; After intervention, Ln (ISI) increased in the trail group and the difference was significant(P<0.05) and the same trend was observed in the control group, but the difference was without significance(P>0.05);The difference of Ln (HOMA-IR) and FINS were not statistically significant (P>0.05) before and after treatment in both groups.4.In the trial group, TC level was significantly decreased (P<0.05)while this change in the control group was without significance (P>0.05);TG, HDL-C, LDL-C levels were all without significance (P>0.05) before and after treatment in both groups;5.TCM symptoms were improved after treatment (P<0.01), and the trail group is better than the control group (P<0.01).6.There was no clinically significant safety index in the testing process, and a low incidence of adverse reactions, so the clinical application was safe.Conclusion:Sancai powder can effectively reduce blood glucose and glycoslated hemoglobin in Newly Diagnosed type 2 diabetes mellitus. The effect is identical with metformin.It can improve the patient’s clinical symptoms significantly at the same time.The Sancai powder could significantly improve insulin sensitivity,improve the function of islet beta cells,decrease TC,while the incidence of adverse reactions is low.It is the effective traditional Chinese medicine powder of controlling blood glucose and blood lipid.