The Phase Ⅱ Clinical Research On The Treatment Of Primary Dysmenorrhea (Blood Stasis Syndrome) With Duerwei Capsule

Objective:To evaluate the efficacy and safety of Duerwei capsule on primary dysmenorrhea(blood stasis syndrome),as well as to provide evidence for its promotion and further application.Methods:Stratified randomized,double-blind,multicenter,control group.Design:out department of Gynecology clinic in the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine during May2013to November2013,42patients fitting the diagnostic criteria, were randomly divided into the first test group,the second test group and the control group.This treatment were set to begin from5-7days ahead of menstrual period.lasting for10days (no intermission during menstrual days), which taking three consecutive menstrual cycles.Recovery patients were followed-up visited for3menstrual cycles. Each symptom score and outcome indicators and safety index changes in the three groups were observed before and after treatment.Results:(1)The curative effect of dysmenorrhea:the first group:Test a set of remarkable rate was14.28%, total effective rate was85.71%; the second group:Test markedly effective rate is0.00%, the total efficiency rate is84.61%;The second group:cured rate of0%, total effective rate was28.57%.The difference for TCM syndromes among three groups is statistically significant(p>0.05).(2)The changes of the dysmenorrhea scores:the changes of the scores within each group after treatment is significant.To further comparison.the changes before and after treatment among all the groups is significantly different。(3)The analysis of the scores about CMSS:The total scores of the degree and duration:the difference of the scores before and after treatment within each group is significant.The total scores of the CMSS:the difference of the scores before and after treatment within each group is significant.The changes of scores among all the groups is not significantly different.(4)The comparison of the fo the TCM symptom, main syndrom and secondary symptom:The curative effect of the TCM symptom:the difference of the scores before and after treantment within each group is significant. the change of scores after treatment among each group is significant. Main symptom:The degree of the dysmenorrhea:the difference of the scores before and after treatment within each group is significant. the change of scores after treatment among each group is significant.The duration of the dysmenorrhea:Only the first group shows significant difference in the comparison between and after treatment with group,and the other two groups shows no significant difference. As for the change of the scores before and after treatment among groups,the significant difference does exit.The color and the character of the menorrhea blood:Only the first group shows significant difference in the comparison between and after treatment with group,and the other two groups shows no significant difference. and the change of the scores among all the groups before and after treatment is not significantly different.Secondary symptom:the volume of menorrhea blood,the swelling pain of breast,dysphoria,relief pain of after getting worm,all of them shows no significant difference between and also the changes among groups after treatment.Conclusion:Duerwei capsule is made of Lamiophlomis rotata and Panax pseudoginseng,with the efficacy of invigorating the circulation of blood,hemostasis,dispersing the blood stasis and relieving pain.This can be used to cure the primary dysmenorrhea(blood stasis symptom),It has no outstanding effect to relieve the degree of the pain,but is has preeminent effect on shorten the duration of the pain.As to the secondary symptom such as the color and character of menstrual blood,the volume and the breast tenderness,it has no obvious curative effect on those symptoms.In this clinical trial,there is no adverse reactions and clinical significance of study drug-related found indicators of physical and chemical examination.on except one patient whose AST and ALT is higher than normal.The safety for clinical application can not be confirmed.This product is worth for further research,exploit and application.