The Clinical Research Of The Treatment Of Using The GuiZhiFuling Capsule On The Primary Dysmenorrhea

Objective:To evaluate the clinical curative effect and drug safety of the treatment of primary dysmenorrhea for the GuiZhiFuling capsule, to provide a valid method for the treatment of primary dysmenorrhea and effective screening of the recipe.Methods:Adopting multicenter, randomized, double-blind, parallel controlled trial, the30patients suffered by the primary dysmenorrheal were selected, divided into test group1and test group2and control group. Test group1were treated with the capsule of GuiZhiFuling, Test group2were treated with1.5times the capsule of GuiZhiFuling control group with placebo for three menstrual cycles. The clinical symptoms and signs, related curative effect data and security data of three groups were observed both before and after treatment.Results:1. Effect of pain-treating. The significant and cure rate to test group1was100%, the total effective rate was100%; The significant and cure rate to test group2was80%, the total effective rate was100%; The significant and cure rate to control group was20%, the total effective rate was60%; There was significant difference between the three groups (P>0.05). Comparing test group1and test group2with control group, there was significant difference (P<0.05); Comparing test group1with test group2, there were no significant difference (P>0.05).2. Effect of pain intensity treating. The significant and cure rate to test group1was90%, the total effective rate was100%; The significant and cure rate to test group2was90%, the total effective rate was100%; The significant and cure rate to control group was40%, the total effective rate was80%; There was significant difference between the three groups (P>0.05). Comparing test group1and test group2with control group, there was significant difference (P<0.05); Comparing test group1with test group2, there were no significant difference (P>0.05). 3. Clinical symptoms effect. The significant and cure rate to test group1was60%, the total effective rate was100%:The significant and cure rate to test group2was60%. the total effective rate was100%; The significant and cure rate to control group was20%. the total effective rate was70%; There was significant difference between the three groups (P>0.05). Comparing test group1and test group2with control group,there was significant difference (P<0.05); Comparing test group1with test group2, there were no significant difference (P>0.05).4. Safety Results. There has not seen other serious adverse reactions cases and other unusual physicochemical test parameters which has the clinical significance and it is much safer in clinical applications.Conclusions:The GuiZhiFuling capsule can improve pain intensity of primary dysmenorrheal and obvious improve the clinical symptoms such as the lower abdomen pain and continuous time period, limbs cold chills, breast pain, bosom frowsty uncomfortable etc. The GuiZhiFuling capsule have significant effect on primary dysmenorrheal. It is worth further studying and spreading widely to clinical application with the characteristic of security, high efficiency and fine stability.