| Objectives:To investigate the effecay and safty of S. Sphenanthera soft capsu-le treating pathogenic fire derived from stagnation of liver-Qi syndrome of pri mary insomnia by a self-controlled studyMethods:By using the self-control design, patients who were diagonosed of p athogenic fire derived from stagnation of liver-Qi syndrome of primary insomni a were enrolled in Neurology Clinic in May2012to May2013. Begin study a fter Informed consent. The researcher evaluated the TCM score and the score of pathogenic fire derived from stagnation of liver-Qi syndrome in0,7,14,21,28day respectively, and evaluated the Pittsburgh sleep quality index in0,7,28d ay respevtively. Then the researcher did Statistical analysis by spss17.0and evaluated the safety by observed the change of blood RT, urine RT, stool RC, blood biochemistry and electrocardiogramResults:45patients were included in the study and7of them were lost of followed up.the result showed the TCM score and the score of pathogenic fir e derived from stagnation of liver-Qi syndrome in7,14,21days after drug adm inistration were impoved compared with the baseline, the difference was statist ically significant(P<0.05).The Pittsburgh sleep quality index in7,21days after drug administration were improved compared with the baseline, the differenc e was statistically significant(P<0.05). It also showed the tempreture, respirat ory rate, resting heart rate, blood bressure, blood RT, blood biochemistry, uri ne RT, stool RT, electrocardiogram were not changed significantly when compa red with baseline.Conclusions:The study Preliminary indicated S. Sphenanthera soft capsule is e ffective and safe in treating pathogenic fire derived from stagnation of liver-Qi syndrome of primary insomnia. But this study has certain limitation, it need f urther Randomized controlled trials and increase sample sizes to comfirm the results. |
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