Objective,2,To evaluate the clinical effect of traditional Chinese herbal medicine (TCHM) treatment based on syndrome differentiation (oral administration and external application of TCHM based on syndrome differentiation with "Yiqi Huayu Bushen method" ) combined with sacral canal block on lumbar disc herniation.,Methods,2,A total of 430 cases collected from 5 sub-centers were randomly divided into treatment group (,n,=215) and control group (,n,=215). The treatment group was given oral administration and external application of TCHM based on syndrome differentiation with "Yiqi Huayu Bushen method" combined with sacral canal block technique, while the control group was administered with conventional western medicine treatment. The course of treatment lasted 2 weeks, and each case was followed up for 4 weeks to observe the safety of medication, and compare the changes of local pain visual analogue scale (VAS) score, Japanese Orthopedic Society (JOA) lumbar score and Oswestry dysfunction index (ODI) score before and after treatment.,Results,2,①During the trial, there were 5 drop-out cases in the treatment group and 5 drop-out cases in the control group. Finally, 420 cases completed the trial, including 210 cases in the treatment group and 210 cases in the control group. ②According to the intra-group comparisons before treatment and at different time points after treatment, the differences in the VAS scores of local pain were statistically significant in both groups (,P,<,0.05), and the VAS scores gradually decreased at different time points after treatment. The VAS score of local pain in the treatment group was lower than that in the control group after 1 week and 2 weeks of treatment respectively, and the differences were statistically significant (,P,<,0.05). There was no significant difference in VAS score of local pain between groups at 4 weeks of follow-ups (,P,>,0.05), and the non-inferiority test was qualified. ③According to the intra-group comparisons before treatment and at different time points after treatment, the differences in the JOA lumbar scores were statistically significant in both groups (,P,<,0.05), and the JOA lumbar scores gradually increased at different time points after treatment. The JOA lumbar score in the treatment group was lower than that in the control group after 1 week and 2 weeks of treatment, and the differences were statistically significant (,P,<,0.05). There was no significant difference in JOA lumbar score between groups at 4 weeks of follow-ups (,P,>,0.05), and the non-inferiority test was qualified. ④According to the intra-group comparisons before treatment and at different time points after treatment, the differences in the ODI scores were statistically significant in both groups (,P,<,0.05), and the ODI scores gradually decreased at different time points after treatment. The ODI scores in the treatment group were lower than those in the control group after 2 weeks of treatment, and the difference was statistically significant (,P,<,0.05). There was no significant difference in ODI scores between groups at 4 weeks of follow-ups (,P,>,0.05). ⑤There was no significant difference in the incidence of adverse reactions between the two groups (,P,>,0.05).,Conclusion,2,Compared with conventional western medicine treatment, oral administration and external application of TCHM based on syndrome differentiation with "Yiqi Huayu Bushen method" combined with sacral canal block technique has the advantage of early therapeutic effect, which can relieve pain symptoms and lumbar dysfunction of patients more quickly. In the follow-up period (mid-term), the therapeutic effect of treatment group is not inferior to that of the control group.