The Phase Ⅱ Clinical Research On The Treatment Of Endometriosis Uterine(Cold Stagnation And Blood Stasis Syndrome)with ChiPu Grain

Objective:To evaluate the efficacy and security of ChiPu grain on endometriosis uterine of cold stagnation and blood stasis syndrome, explore the clinical effective dose and provide bases for its promotion and application.Methods-. Stratified randomization, double-blind, multicenter and placebo-controlled design were performed. Selected32patients presented to gynecological clinic. Affiliated hospital of Chengdu University of Traditional Chinese Medicine and Jiangsu Province hospital of TCM from Dec.2011to Jan.2013. All subjects were randomly divided into the testl group, the test2group and the control group. The course of treatment was set as starting medication at5-7days before menstruation, taking for4weeks and taking for3menstrual cycles consecutively,no need stop during period. Cured cases were followed up for12weeks to observe the symptom scores before and after treatment in three groups as well as the changes of relevant efficacy indexes and security index.Results:C1) The efficacy of TCM syndrome:The cured and markedly effective rate was50%and the total effective rate was90%in test1group. In test2group, the cured and markedly effective rate and the total effective rate was18.18%and90.91%respectively. In the control group, the cured and markedly effective rate and the total effective rate was0and14.3%respectively. There was a significant difference among the three groups (P<0.01). No significant difference was found between test1group and test2group (P>0.05).The test1group achieves the same curative effect as that of test2group. The curative effects of test1group and test2group on improving TCM syndrome are superior to that of control group.(2)The efficacy of the integral of dysmenorrheal:The cured and markedly effective rate was20%and the total effective rate was90%in test1group. In test2group, the cured and markedly effective rate and the total effective rate was0and81.82%respectively. In the control group, the cured and markedly effective rate and the total effective rate was0and14.3%respectively. There was a significant difference among the three groups (P<0.01). No significant difference was found between test1group and test2group (P>0.05).The test1group achieves the same curative effect as that of test2group. The curative effects of test1group and test2group on improving the integral of dysmenorrheal are superior to that of control group.(3) The efficiency of the degree of the average pain:there was a significant difference within groups before and after treatment (all P<0.01), and there was a significant difference among the three groups after treatment (P<0.01). In respect of shortening the average pain, Test1group is superior to control group.(4) The efficiency of the degree of the maximized pain:there was a significant difference within groups before and after treatment (all P<0.01), and there was a significant difference among the three groups after treatment (P<0.01). In respect of shortening the the maximized pain, Test1group is superior to control group.(5) The changes of duration time of pain:there was a significant difference within groups before and after treatment (all P<0.05), and there was a significant difference among the three groups after treatment (P<0.05). No significant difference was found between test1group and test2group (P>0.05).(6) Comparisons of the efficiency of TCM minor symptom:test1group and test2group achieve better curative effects than contrast group does in terms of pain during sex, persistent hypogastralgia, sensation of chill,dark-red menstrual blood with blood clots.There were significant differences in the comparisons of minor symptoms after treatment among the three groups (P<0.05) except that no statistical difference was found in abdominal mass, pain at stationary body parts,pain relieved by warmth and quantity white leucorrhea after treatment (P>0.05).(7) Security results:found no adverse reactions and physical-chemical examination indexes with clinical significance about investigational medication in this trial, so the clinical application is comparatively safe.Conclusion:ChiPu grain can obviously alleviate menstrual pain, shorten the duration time of dysmenorrheal, improve pain during sex, persistent hypogastralgia, pain at stationary body parts, pain relieved by warmth, sensation of chill,dark-red menstrual blood with blood clots, quantity white leucorrhea and other symptoms. The product is safe and convenient in clinical application so it is worthy of further promotion.