OBJECTIVETo evaluate the safety and effectiveness of Shengji Ointment (SO) (by external use) in treating infective ulcer patients with yang syndrome (YS).

METHODSA multicenter, stratified, randomized controlled clinical study was used in this study. A random digit table was formed in the ratio of 3:1,440 infective ulcer patients of YS from 5 centers were recruited, 330 in the treatment group (external use of SO, exchange once every 24 h) and 110 in the control group (external use of Votalin, exchange once every 24 h). The therapeutic course consisted of 21 days. The ulcer area, wound depth, pain degree were observed before treatment at day 3, 7, 14, and 21, and safety indices monitored at the same time.

RESULTSThe ulcer area was significantly reduced in the treatment group after 21-day medication, obviously superior to that of the control group (P = 0.002). Ulcer areas at different time points were analyzed. From the 7th day of medication the reduced area was obviously less in the treatment than in the control group (P = 0.002). Besides, the longer the more obvious difference. Compared with the control group, the healing rate of ulcer area, the pain disappearance rate, and the healing rate of ulcer depth were all obviously improved in the treatment group (all P < 0.01). No adverse event occurred in the two groups.

CONCLUSIONSExternal use of SO was safe and effective in treating infective ulcer patients with YS. It could accelerate wound healing with better analgesic effect.