OBJECTIVE: To observe clinical efficacy and safety of asiaticoside topical and oral application combined with tranilast in the treatment of traumatic scar hyperplasia. METHODS: 126 patients with traumatic scar hyperplasia were selected from dermatology department of Xingtai municipal people’s hospital during Dec. 2014 to Dec. 2015, and then divided into control group and observation group according to treatment plan, with 63 cases in each group. Both groups were given Tranilast capsules, 0.1 g each time, tid; observation group was additionally given moderate Asiaticoside ointment for external use, 3-4 times a day and Asiaticoside tablets orally, 12-24 mg each time, tid. Both groups were treated for 8 weeks. Clinical efficacy, recurrence rate with 1 year, average medication duration, symptom disappearance time and satisfactory degree of treatment were compared between 2 groups as well as the occurrence of ADR. RESULTS: After treatment, total effective rate of observation group (93.65%) was significantly higher than that of control group (77.78%); recurrence rate with 1 year (4.76%) was significantly lower than control group (15.87%), with statistical significance (P<0.05). Average medication duration and symptom disappearance time of observation group were significantly shorter than those of control group, and satisfactory degree of treatment was significantly higher than control group, with statistical significance (P<0.05). The incidence of ADR in observation group (6.35%) was significantly lower than in control group (17.46%), with statistical significance (P<0.05). CONCLUSIONS: Asiaticoside topical and oral application combined with tranilast show significant therapeutic efficacy for traumatic scar hyperplasia, and can reduce the recurrence rate of scar hyperplasia, shorten medication duration and symptom disappearance time with good safety.