Randomized And Controlled Study On Xin-Sheng-Ning Slice In Treatment Of Insomnia Patients With Heart-spleen Deficiency And Disturbance Of Deficiency-heat Inside The Body

Objective:Through the study and research on this clinical trial judgements deeply reveal the clinical efficiency and safety of the treatment by Xin-Sheng-Ning slice on heart-spleen deficiency and disturbance of deficiency-heat inside the body.Method:The test adopted randomization of layering, double blind, placebo of confrontation method,In this clinical study, to be sure of observing 48 cases. Be parted of two groups at random,the ratio of treat group to control group was 21:27. After elution time,the period of treatment lasted for three weeks.Before and at the end of this period, every patient of the two groups would get evaluated according to measurement of the sleep quality, scores of Chinese medicine symptom, Pittsburg sleep quality index(PSQI),and get evaluated according to measurement of self-rating anxiety scale(SAS) and self-rating depression scale (SDS) with anxiety and depression.Adverse reaction would be observed and recorded.Results:The rate of complete reductiondosage was 57.14% and The effective rate in the treatment group is 95.23% in treating group, and the rate of complete reductiondosage of the control group of placebo is 23.07% and The effective rate of placebo is 34.64%, which have difference. The PSQI was significant difference in both groups between before and after the treatment(P<0.05). Difference of The PSQI WAS variance in both groups between before and after the treatment (P<0.05). The total heart-spleen deficiency and disturbance of deficiency-heat inside the body efficiency rate of the treat group was 80.95% and the control group of placebo was 38.46%, which have difference. Difference of The PSQI WAS no variance in both groups between before and after the treatment (P<0.05)Conclusion:The assistant treatment on heart-spleen deficiency and disturbance of deficiency-heat inside the body by Xin-Sheng-Ning slice can have good effect on insomnia.As well as bring down the impact of TCM syndrimes and improve sleeping quality and daily activities.Safety examination finds no abnormality.During the testing period,no harmful reaction appears which point out that this medicine is relatively safe.