| Objective:To preliminarily evaluate the clinical effect and security of zhenggong capsule in treating endometriosis (syndrome of congealing cold with blood stasis) forecast its market value, and search for a patent medicine of TCM with high efficiency and low side-effect for the disease.Methods:68 patients suffered by the endometriosis (syndrome of congealing cold with blood stasis) were selected, randomly divided into test group and control group with double-blind, Single-simulation, positive control method. Test group were treated with zhenggong capsule, control group with guizhifuling capsule, for 12 weeks. The clinical symptoms and signs, related curative effect data and security data of tow groups were observed both before and after treatment.Results:A, Pain effect:For test group, the evident cure rate (ECR) of is 64.51%, total efficiency rate (TER) is 93.54%, control group respectively 51.61%,90.32%. There is no significant difference between tow groups by the analysis of SPSS 17.0. (p>0.05).B, Symptoms effection:The ECR of test group is 64.51%, TER is 96.77%; control group respectively 51.62%,96.78%. There is no significant difference between tow groups by the analysis of SPSS 17.0. (P>0.05).C, Mass effection of shaofu:The ECR of test group is54.17%, TER is 70.84%; control group respectively 45.00%,55.00%. There is no significant difference between tow groups in partial sign by the analysis of SPSS 17.0. (P>0.05).D, Ultrasonic test:Compared within each group, test group ultrasound before and after treatment was statistically significant (P< 0.05), control group ultrasound before and after treatment was not statistically significant (P>0.05). There has no significant difference between tow groups in ultrasonic test result. (P>0.05).E, Safety analysis:In this experiment, there is a case that presents adverse reactions in test group of zhenggong capsule, Tow adverse reactions cases in control group, but the symptom is not serious, and can be controlled quickly through proper treatment. In addition, there has not seen other serious adverse reactions cases and other unusual physico-chemical test parameters which has the clinical significance. So the usage of zhenggong capsule for clinic is safe.Conclusions:zhenggong capsule is effective and safe in treating endometriosis (syndrome of congealing cold with blood stasis), can evidently better the clinical symptoms like menstrual pain, color purple or dark blood clots, fixed pain, baldwin pain reduction, persistent abdominal pain or dyspareunia, cold limbs etc portional signs. It is worth further studying and spreading widely to clinical application with the characteristic of security, high efficiency, no poisonous and adverse function. |