Abstract:Objective To investigate the clinical effect and safety of Tianma Xingnao Capsule in the treatment of mild or moderate vascular dementia with deficiency of liver and kidney and liver disturbance. Methods In this randomized, double-blind, parallel-controlled, and multicenter clinical trial, 180 patients with vascular dementia from 12 centers were randomly divided into trial group (135 patients treated with Tianma Xingnao Capsule) and control group (45 patients treated with Compound Congrong Yizhi Capsule) at a ratio of 3∶1, and the course of treatment was 24 weeks for both groups. The two groups were compared in terms of Alzheimers Disease Assessment Scale-cognitive subscale (ADAS-cog) score, Scale for the Differentiation of Syndromes of Vascular Dementia (SDSVD) score, Mini-Mental State Examination(MMSE) score, Activities of Daily Living (ADL) score, and safety. Results A total of 165 patients (123 patients in the trial group and 42 in the control group) completed the trial. Seven patients were lost to follow-up, with 5 in the trial group and 2 in the control group; protocol violation was observed in 8 patients, with 7 in the trial group and 1 in the control group. Both groups had a significant change in ADAS-cog score after 36 weeks of treatment (P<0.05). After 24 weeks of treatment, both groups had a significant reduction in SDSVD score (P<0.05), and the trial group had a significantly greater reduction than the control group (P<0.05). After 36 weeks of treatment, both groups had significant increases in MMSE and ADL scores (P<0.05), and after 36 weeks of treatment, there were significant differences in MMSE and ADL scores between the two groups (P<0.05). No adverse events caused by Tianma Xingnao Capsule were observed. Conclusion Tianma Xingnao Capsule treatment for 24 weeks can improve patients cognitive function and quality of life, which can last for at least 12 weeks, with a marked clinical effect and good safety.