The Phase â…¡ Clinical Research On The Treatment Of Primary Dysmenorrheal (Qi Stagnation And Blood Stasis Syndrome)with Angelica Dysmenorrhea Particles

Objective:To evaluate the efficacy and security of Angelica dysmenorrheal part icles on primary dysmenorrheal of qi stagnation and blood stasis syndrome, pro vide evidence for its promotion and application.Methods:Stratified randomized,double-blind,multi-center,control group Design.Gynecology clinic of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine in January2013, June2012,33patients met the diagnostic criteria, were randomly divided into test group, the second test group and control group.The treatment is set to begin from5days before menstruation,total for7days (menstrual two days), taking three consecutive menstrual cycles.Cured patients were followed up for3cycles. Each symptom score and outcome indicators and safety index changes in the three groups were observed before and after treatment.Results:(1) TCM syndromes:Test a set of markedly effective rate was45.45%, total effective rate was90.9%; Test markedly effective rate was27.27%, the total efficiency of72.73%. The control group cured rate of0%, total effective rate was36.36%.The difference for TCM syndromes of three groups was statistically significant(P<0.05). The difference between the first group,the second group and the control group was statistically significant(P<0.05).The difference between the first group and the second group was not statistically significant (P>0.05).(2) TCM syndrome score change:TCM syndrome score within the group of the three groups before and after treatment comparison, a significant difference (P<0.01).After treatment, the symptom score comparison between groups (points before treatment subtract points after treatment) was a significant difference(P <0.05).(3) Changes in the degree of pain:The degree of pain score comparison for three groups before and after treatment were significant differences(P<0.05).The comparison of the degree of pain between the three groups after treatment (pre-treatment score substract after-treatment score) was a significant difference (P<0.05).(4) Changes in the duration of pain:The difference of the first group and the second group before and after treatment comparison was statistically significant (P<0.05). The group difference of control group was not statistically significant (P>0.05). The difference after treatment between three groups was statistically significant (P<0.01).(5) The TCM times herniation:TCM syndrome score within the group of the three groups before and after treatment comparison, a significant difference (P<0.01).Menstruation associated with changes in the line of poor:Test the difference between the two groups before and after treatment group were statistically significant(P<0.05), Test group and the control group before and after treatment groups was not statistically significant(P>0.05); Three groups after treatment between the two groups showed no significant difference(P>0.05).Comparison of menstrual qualitative and color change:The group differences of the first test group and the second test group before and after treatment were statistically significant(P<0.05),The group difference of the control group before and after treatment was not statistically significant(P>0.05); Three groups after treatment between the two groups showed no significant difference(P>0.05).Comparison of breast tenderness changes:The group differences between the three groups before and after treatment were statistically significant(P<0.05).Th e differences after treatment between the three groups were not statistically significant (P<0.05).Comparison of chest discomfort changes:The difference before and after treatment in the three groups was not statistically significant (P>0.05).Differ ence between the three groups after treatment was not statistically significant (P>0.05),so not compare between groups.(6) Safety results:In this clinical trial,found no adverse reactions and clinical significance of study drug-related indicators of physical and chemical examinati on.The clinical application is safe.Conclusion:Angelica dysmenorrheal particles can significantly reduce the deg ree of menstrual pain, shorten the duration of dysmenorrheal, improve the symptoms of breast tenderness. The product is safe and convenient in clinical use,and therefore worthy of further promotion.