To evaluate the efficacy and safety of Linggui Zhugan granules and slices in the treatment of metabolic syndrome.Methods:A randomized,controlled research were conducted with 280 subjects who are randomly divided into Linggui Zhugan granules group and Linggui Zhugan slices group.During16 weeks of treatment,insulin resistance index,fasting blood glucose,metabolic syndrome components and safety indicators are observed,and the safety differences were concluded between the two groups.Conclusion:By adopting a randomized,controlled,evaluation on grouping unknown,equivalence clinical study,as well as standardized drug combination and exercise with diet,the standardization and scientificity of the research can be ensured.This can guarantee the reliability and credibility of outcomes and verify the clinical effect and safety of traditional Chinese medicine (TCM) granules.It provides evidence for the clinical application of TCM granules.