To investigate efficacy and safety of Jianpi Zhixie Granule on chronic diarrhea of AIDS patients. Methods:In the multi-center, open-label, controlled and randomized clinical trial, 143 AIDS patients with the symptom of chronic diarrhea were randomized to take Jianpizhixie granule (n=96) or Loperamide capsule(n=47, 2mg, 3times per day) for 2 consecutive weeks. The primary efficacy endpoints were score of Diarrhea Questionnaire, total stool volume and frequency changes relative to baseline levels. The safety parameters include adverse events, liver function, renal function, ECG, routine blood, urine, stool test, fecal occult blood, HIV-RNA and other laboratory indicators. Results:At week2, the score of Diarrhea Questionnaire between the two treatment arms was significantly different (P=0.0196). At week1, change of total stool volume was significantly different (P=0.0497). Conclusion: The Jianpizhixie granule has better efficacy and safety than Loperamide capsule on chronic diarrhea of AIDS patients.