Abstract:To evaluate the safety and effectiveness of Danhuang Quyu Capsule in treating sequelea of pelvic inflammatory disease and to provide clinical test evidence for protection, registration and application of corresponding Chinese materia medica species. Methods:Random, positive drug paralleled control, double-blind & single, multicenter trials were designed and organized. The total subjects were 424 cases, including 318 cases of treatment group and 106 cases of control group. Patients in the treatment group were treated with 3 Danhuang Quyu Capsules and a simulation agent of Danhuang Quyu Capsule for oral-taking, 3 times per day. Patients in the control group were treated with 4 Zhitong Huazheng Capsules for 3 times per day. Patients in both groups received 8-week treatment and were visited once a month. Patients who were cured were followed up 4 weeks after the trial. Results:It showed significant difference between the treatment group and the control group on main symptom disappearance rate, curative rate of comprehensive rate and effective rate, and the treatment group was superior to the control group. There was significant difference between the treatment group and the control group in TCM syndrome curative effect, including the curative rate and the effective improvement rate, and the treatment group was better than the control group. For local improvement, the PPS good improvement rate of treatment group was better than that of the control group, with statistically significant difference. Conclusion:It is safe and effective for Danhuang Quyu Capsule to treat sequelea of pelvic inflammatory disease of blood stasis due to qi deficiency syndrome and phlegm-dampness blocking collaterals syndrome. The clinical effect of Danhuang Quyu Capsule is superior to Zhitong Huazheng Capsule.