Abstract: OBJECTIVE To assess the effect of regulating liver and activating spleen therapy on patients with diarrhea-irritable bowel syndrome (D-IBS) belonging to liver depression and spleen deficiency type as well as its safety.METHODS 96 cases conforming to the including criteria were randomly divided into treatment group and control group with 48 in each. 1 case of the treatments and 2 cases of the controls fell off as they did not return visit since the first consultation. The treatment group were given traditional Chinese medical formula Tiaogan Yunpi Fang for regulating liver and activating spleen， the control group were administrated with Deshute. The course of two groups was 4 weeks. Symptoms， signs and tests results of the patients before and after treatment were collected and analyzed. RESULTS The treated patients were better than control patients in total effective rate and recovery rate (P<0.05). Symptom score of both groups significantly decreased after treatment， but the treatment group was superior to the control (P<0.01). The symptom score of treatment group decreased in comparison with that before treatment (P<0.05). All the symptoms of control patients were improved except for non-complete defecation (P<0.05). However， abdominal pain and discomfort， defection frequency， feces property of the treated patients were improved significantly， much better than those of the control (P<0.05). There was no adverse reaction in two groups. Regular blood test， urine test， stool test， ALT， BUN， Scr were not found abnormal. CONCLUSION Tiaogan Yunpi Fang is effective on D-IBS with great safety.