Objective To analyze the clinical effect of Kangaibaosheng Traditional Chinese Medicine（TCM）preparations on HIV/AIDS. Methods A total of 1038 HIV/AIDS patients， who took Kangaibaosheng preparations without HAART treatment during March 2010 to December 2005 in medical institutions across Yunnan， were collected. Their clinical symptom scores， Karnovsky scores， CD4 counts， HIV-RNA loads， blood routine parameters， liver and kidney functions and other indexes were analyzed before and after treatment. Results Clinical sympptom score： after treatment， the total score at each time point decreased（P<0.01）， and the score of each individual symptom， such as fever， cough， fatigue， anorexia， diarrhea， emesis， shortness of breath， chest distress， spontaneous sweating， night sweating， nausea， hair loss， headache， abdominal pain， joint pain， back pain， itchy skin， menstrual disorder（female） and skin rash， declined（P<0.05）. Karnovsky score： after treatment， the Karnovsky score at each time point increased（P<0.01）. CD4 count：according to CD4 hierarchy of enrolled patients：（1）≥350/μL： the CD4 count after treatment at each time point decreased（P<0.05）； （2）（201~349）/μL： the CD4 count after treatment at each time point increased（P<0.05）； （3）≤200/μL： the CD4 count increased in the sixth month after treatment（P<0.01）. Viral load：there was no statistically significant difference between the first and the second detection values（P<0.05）. Security index： platelet count declined slightly， and the differences for other security indexes before and after treatment were not statistically significant. Conclusions Kangaibaosheng preparations can improve clinical symptoms and life quality of HIV/AIDS patients， and promote or stabilize their immune functions；for enrolled patients whose CD4 levels were different， Kangaibaosheng preparations have different curative effects.