Clininal Study Of Kadsura Longepedunculata Soft Capsule On Insomnia

objective:To evaluate the clinical efficacy and safety of Kadsura longepedunculata soft capsul through the variation of PSQI、daily time to fall asleep、the average ratio between daily time of night sleep and awakening time and TCM symptoms score.Method:All the210cases from multiple-centre met diagnostic standard of insomnia of ICSD and TCM symptoms.The two groups were divided in random double-blind method and the treatment course lasted four weeks. The treatment group (158cases), oral Kadsura longepedunculata soft capsul, the control group (52cases) oral placebo.We used SAS9.1.3to analysis the data about PSQI, TCM symptoms score before and after drug medication used respectively in4weeks.Result:There is comparability of the demography characteristics, severity, duration and history according to statistic analysis of the two groups. Before treatment, the total value of PSQI is12.72±2.76(Kadsura longepedunculata soft capsul) and12.88±2.60(placebo) respectively, and the ones after treatment is7.65±4.61(Kadsura longepedunculata soft capsul) and8.46+4.45(placebo) respectively, so there is statistical significance comparing the value of PSQI after treatment with the ones before treatment(p<0.01), but there is no statistical significance between the two groups(P=0.9922). Six TCM syndrome types of insomnia including syndrome of exuberance of heart fires、pathogenic fire derive from starnation of liver-Qi、deficiency of both heart and spleens asthenia of gallbladder and heart、pyrophlem internal disturbance and Hyperactivity of fire due to yin deficiency have statistical significance comparing the value of PSQI after treatment with the ones before treatmcnt(p<0.01)。 but there is no statistical significance between the two groups。 The rate of side effect of two groups is3.8%(Kadsura longepedunculata soft capsul) and7.69%(placebo), there is no statistical significance between the two groups(P=0.4421).Conclusion:The effect of Kadsura longepedunculata soft capsul in clinical treatment of insomnia is same as the one of placebo.And the effect of treatment in theTCM syndrome of pathogenic fire derive from starnation of liver-Qi of insomnia is better than the others.We could re-evaluate in this area through expanding the sample size.The research also supplied a new way of the treatment of insomnia.