Efficacy evaluation of Shugan Jianpi Yangxin Prescription for insomnia disorder:a multicenter,randomized,double-blinded,placebo controlled clinical trial

WANG Xu; ZHANG Jie; ZHAO Min; SONG Xiao-yu; DUAN Jian-ping; MA Sen; GUO Yang; WANG Xiao-chun; ZHANG Hong-ju; WANG Feng

doi:10.20251/j.cnki.1003-3734.2025.21.008

Abstract：Objective:To evaluate the clinical efficacy and safety of Shugan Jianpi Yangxin Prescription in patients with insomnia disorder combining liver depression and spleen deficiency.Methods:This was a three-center,randomized,placebo controlled trial.A total of 130 patients of insomnia disorder with the Chinese medicine pattern of liver depression and spleen deficiency were enrolled and divided evenly into control and trial groups in this study.65 patients in trial group were treated with Shugan Jianpi Yangxin Prescription granules,and 65 patients in control group were treated with placebo granules of Shugan Jianpi Yangxin Prescription.All patients received a 4-week treatment course followed by a 4-week follow-up period.After 4 weeks of intervention,the changes in Pittsburgh Sleep Quality Index(PSQI)scores,Insomnia Severity Index(ISI)scores and Traditional Chinese Medicine(TCM)syndrome evaluation scale scores were analyzed between the two groups.Safety indicators was evaluated through vital signs,laboratory tests(blood routine,urine routine,liver/kidney function),and electrocardiogram results.Changes in ISI scores between the two groups were analyzed at weeks 6 and 8.Results:After 4 weeks'treatment,the total response rate was 93.85%in the trial group and 69.84%in the control group.There were significant differences between the trial and control groups in the following indexes:the PSQI scores,ISI scores,the TCM Syndrome Evaluation scale,and single symptoms of TCM syndromes including difficulty falling asleep,dream-disturbed sleep with easy awakening,low mood or irritability,and mental fatigue.Vital signs,laboratory parameters,and ECG results remained normal in both groups.No adverse reactions or adverse events were recorded.There were no adverse and serious adverse events during the treatment period in the trial and control group either.Conclusion:Shugan Jianpi Yangxin Prescription can significantly improve the clinical efficacy in patients with insomnia disorder combining liver depression and spleen deficiency.It had advantages in alleviating symptoms such as difficulty falling asleep,frequent nightmares or awakenings and the accompanying symptoms.