Abstract: OBJECTIVE  To observe the clinical efficacy of the Jinqiaomai pill combined with salazosulfapyridine (SASP) treating ulcerative colitis (UC), and to explore its effects on Toll-like receptor 4 (TLR4) and nucleotide oligomerization structural domain-like receptor protein 3 (NLRP3) signal pathway-related proteins.METHODS  72 outpatients with UC of dampness-heat in large intestine were enrolled and divided into the treatment group and control group, 36 cases in each group. The control group was given SASP orally, and the treatment group was given the Jinqiaomai pill combined with SASP. Traditional Chinese medicine (TCM) syndrome scores, improved Mayo scores, mucosal healing rates, serum inflammatory cytokines, changes of colon mucosal inflammation-related proteins, and the adverse reactions in both groups were observed.RESULTS  After treatment, except for scanty dark urine, the TCM syndrome scores in both groups were lower than those before treatment, and among which the scores of diarrhea, abdominal pain, tenesmus and others were significantly decreased (P < 0.05). The improved Mayo scores of the two groups were significantly decreased (P < 0.05), with equivalent reduction in both groups. The mucosal healing rate of the treatment group was 66.67%, obviously higher than the control group (P < 0.05). The levels of serum interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α) also dramatically declined (P < 0.05), especially in the treatment group (P < 0.05). The colon pathology, levels of TLR4, and NLRP3 of the treatment group were obviously declined (P < 0.05). The adverse effect rates between the two groups showed no significant difference.CONCLUSION  As for treating UC, Jinqiaomai pill combined with SASP has better effect than SASP alone. The mechanism may be through the intervention of the TLR4/NLRP3 signal pathway, functioning as anti-inflammatory and immune adjustment.