Objective To evaluate the effectiveness and safety of Chaibei Zhixian Decoction（柴贝止痫汤） combined with anti-epileptic drugs（AEDs） for the treatment of patients with drug-resistant focal epilepsy（DRFE） and consciousness disturbance of phlegm-qi constraint and stagnation（PQCS） pattern. Methods A block randomized

placebo-controlled parallel trial was designed. PQCS patients with consciousness disturbance of PQCS pattern were randomly divided into treatment group（36 cases） and control group（35 cases）. Based on the conventional AEDs

Chaibei Zhixian Decoction was administered in treatment group while placebo was given in control group

one dose per day for 3 months. The frequency of seizures

the 50% response rate（RR）

the complete remission rate

and the Liverpool seizure severity scale（LSSS） scores were compared between groups at different time points

and the safety of the interventions was evaluated. Results After 3-month treatment

the frequency of seizures and the LSSS score of the treatment group were significantly lower than those of the control group

while the complete remission rate of the treatment group was higher than that of the control group（P<0.05）; the LSSS score of the treatment group decreased more than that of the control group（P<0.01）. The 50% RR of the treatment group was significantly higher than that of the control group when assessed after 2-month treatment and after 3-month treatment（P<0.05 or P<0.01）. No adverse events in relation to the add-on therapy of Chaibei Zhixian Decoction were found. Conclusion Chaibei Zhixian Decoction combined with AEDs can decrease the frequency of seizures and reduce the severity of seizures in DRFE patients with consciousness disturbance of PQCS pattern

and is safe.