Abstract: AIM: To evaluate the clinical efficacy and safety of the Weishuan pellets in treatment of patients with functional dyspepsia.METHODS: 409 subjects were involved in a multi-center randomized , doubleblinded, double-simulation , and positive drug parallelcontrolled clinical trail.308 patients were enrolled in the Weishuan-pellets grouP, while 101 cases were enrolled in the control group.RESULTS: The total effective rate and recovery and excellence rate in Weishuan pellets were 95.70% and 63.03%, respectively ;In the control grouP, the total effective rate and recovery and excellence rate were 94.06% and 62.38%, respectively.For the effects on Piman synodrome , the total effective rate and recovery and excellence rate were 92.07% and 62.04%,respectively ;In the control grouP, the total effective rate and recovery and excellence rate were 87.12% and 54.45%, respectively.For effects on gastric emptying function , in the treatment grouP, the total effective rate and recovery and excellence rate were 73.85% and 60.78%, respectively ;In the control grouP, the total effective rate and recovery and excellence rate were 70.37% and 59.26%, respectively.There was no significant difference between the two groups (P>0.05).CONCLUSION: Weishuan pellet is an effective and safe drug in treatment of patients with functional dyspepsia.

Key words: weishuan pellet, functional dyspepsia, clinical trial