Xiang Ji Depressurizing Pellet' Multicenter Clinical Study On The Efficacy And Safetyt To Essential Hypertension (Overabundant Liver-Fire Syndrome)

Objective: To evaluate the clinical efficacy and security of xiangji Depressurizing Pellets in the treatment of patients with mild to moderate Essential Hypertension of Overabundant Liver-Fire syndrome in comparison with Niuhuang Depressurizing pills. Methods: The double blind, randomized, double mimesis, positive medicine controlled of equal rank, multi-center second period trail was adapted to access 240 patients (EH of overabundant liver fire) who were divided into the treatment group (n=120,treated with xiangji Depressurizing Pellets, third a day) and the control group(n=120,treated with Niuhuang Depressurizing pills, third a day).There were 224 cases in intention-to-treat(ITT),and 216 cases in per-protocol population(PP). The study group(ITT: n=112. PP: n=109.) received xiangji Depressurizing Pellets and the control group (ITT: n=112. PP: n=107.) were given niuhuang Depressurizing pills. The duration of treatment for both groups was 28 days. Results: Blood pressure began to decline in the first week of treatment. After 4 weeks, the mean diastolic and systolic blood pressure dropped 9.963 and 13.486mmHg,respectively,in the treatment group; 8.439 and 11.037mmHg dropped respectively in the control group. xiangji Depressurizing Pellet could markedly depressurize blood pressure of patients(P<0.05), The value of synthesis curative efficacy: in ITT, the total effective percentage in the study group was 21.43%, and 10.71% in the control group, in PP, the numbers were 22.02% and 10.28%, they showed obvious statistical difference(ITT: CMH=4.7353 P=0.0296; PP:CMH=5.3408 P=0.0208). there was no significant difference (P>0.05) between two groups before treatment. Conclusions, xiangji Depressurizing Pellets have confirmed that the effects on mild to moderate hypertension has more superior efficacy than the control drugs. No adverse effect was found in the study. Conclusion: xiangji Depressurizing Pellet is effective and safety in the treatment of Essential Hypertension (Overabundant Liver-Fire syndrome), the conclusion is awaiting to be confirmed by the third period clinical trail.