Abstract:To study the syndrome curative effect, disease curative effect and their correlation of Luohua Zizhu Tablet in treating upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids with syndrome of heat (blood stasis), and to explore clinical evaluation model of new traditional Chinese medicine by combining syndrome and disease with syndrome curative effective as main index. Methods:Patients with upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids with syndrome of heat (blood stasis) were selected to observe syndrome curative effect, disease curative effect and their correlation according to random stratified grouping, parallel-controlled, double-blind and double-simulation trials. Results:1)There were no statistical significance (P>0.05) between Luohua Zizhu Tablet and control drugs to treat syndrome of heat (blood stasis) and to treat diseases of upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids. Luohua Zizhu Tablet could reduce the integrals of sore throat, lower abdominal pain, lumbar and sacral pain, hematochezia and anal swelling (P<0.05). 2) There are relative statistical significance (P<0.05) between syndrome curative effect and disease curative effect of Luohua Zizhu Tablet to treat upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids with syndrome of heat (blood stasis). The syndrome integrals and sore throat integrals of upper respiratory tract infection patients with high WBC integrals had significant correlation to WBC. The syndrome integrals of chronic pelvic inflammatory disease patients with high WBC integrals had significant correlation to WBC. There were relative statistical significance (P<0.05) between disease curative effect and hematochezia curative effect. Conclusion:1) Luohua Zizhu Tablet can effectively treat upper respiratory tract infection, chronic pelvic inflammatory disease and bleeding hemorrhoids. 2) There are relative statistical significance (P<0.05) between syndrome curative effect and disease curative effect and curative effect of index responding to the characteristics of the disease characteristics of Western Medicine. There are relative statistical significance (P<0.05) between syndrome integrals, main symptom integrals and index responding to the characteristics of the disease characteristics of western medicine or main symptom.