Gomi Lipid-lowering Capsule Treatment Of Hyperlipidemia (qi Stagnation) Clinical Safety And Efficacy Phase ¢ò Clinical Study

Objective: Exploring the clinical curative effect and safety of Wuwei Jiangzhi capsule in treating Hyperlipidemia (HLP) ( syndrome of stagnation of Qi and sludging of Blood). Methods: Adopted randomization, double blindness, positive medicine control of equal rank, multi-central clinical trial method, in this trial selected 240 suitable cases whom were parted two groups at random , the ratio of treat groups to control groups was 1: 1. The treat group took the Wuwei Jiangzhi capsules (0.9g, tid ),the control groups took the Zhikeqing capsules (0.9g, tid ),all the capsules were taken in half hour after meals. The period of treatment is 6 weeks. Every patient, when they had taken the capsules for three weeks , they should com back making a observation of treatment. After six weeks, We observed the curative effect of HLP, record the symptoms'change of TCM and signs'of HLP and normal physiology, for the symptom and safety analysis. Results: Curative effect evaluation: After the trial there were 227 cases in intention-to-treat (ITT),219 cases in per-protocol population(PP). Curative effect valued by the PP crowd . In the treat groups ,showed better curative effect in treating HLP and symptoms of TCM , the signs had changed much better than before took the capsules .The total effective percentage was 69.37%, the average effective percentage of syndrome of stagnation of Qi and sludging of Bloods, was 69.48%. Higher then control group's 57.41% and 64.64% ,but there was no significant diference between two groups (P>0.05), maybe this was caused by the limited of simple size ,we hope in next amplifying samples'clinical trial the situation will change. Safety analysis: There were no untoward reactions in both treat group and control group in the clinical trial. Conclusion: In this multi-central clinical trial ,Wuwei Jiangzhi capsule has a credible curative effect, safe and steady function with no side effect. It is a satisfied Chinese medicine in curing hyperlipidemia (syndrome of stagnation of Qi and sludging of Blood). The ultimate conclusion still depends on further confirmation by amplifying samples'clinical trial.