| Objective:To assess the clinical safety and effectivity of the yangyintongnao granule during treating the convalescence of apoplexy through Stagell Clinical Research; to make the evidence for the Stage III Clinical Research.Methods:Adopting the multicenter clinical trial which is random, include double-blind and single stimulation, parallel contrast between positive drug and placebo. The clinical trial was completed by 8 Drug Clinical Trial Organization. All the patients accorded with the diagnostic criteria of Atherosclerotic cerebral infarction and the convalescence of apoplexy. The ages ranged from 40 to 70. All 288 patients were divided into four groups randomly:high-dose group, low-dose group, positive-drug controlled group, placebo controlled group. All the groups had the same number. Dose Schedule:High-dose Group-yangyintongnao granule,5.5g one time, three times one day; Low-dose Group-yangyintongnao granule,5.5g one time, two times one day; positive-drug controlled Group:xiaoshuantong granule, 10g one time, three times one day; imeplacebo controlled Group:placebo 5.5g one time, three times comprehensive effect of treatment, NIHSS, the level of disability, BARTHE index, QLI. Secondary effective indexes included:blood rheology, coagulation index, the syndromes of Traditonal Chinese Medicine. Safety indexes included:blood routine checking, urine routine checking, manure checking, occult blood checking of manure Liver and kidney function, ECG, etc. Four follow-ups were arranged during the study. The first follow-up was at the moment of selecting cases; the second follow-up was at the end of 14 days treatment, we evaluated the clinical symptoms, signs and correlated measuring scales; The third follow-up was at the end of 28 days treatment, we evaluated clinical symptoms, signs, and the correlated measuring scales, and made the laboratory examination to assess effectivity and safety of the drug. The fourth follow-up was at the 180 days after having the diseases, we assessed the variable measuring scales. The population for Statistical analaysis included Full Analysis Set, Per-Protocol Set, Safety Set. SAS(8.2) software were used to analyze the data.All Statistical analaysis were performed through two-sided test.The value less than or equal 0.0167 was considered significant.Results:1.The contrast between the scores of NIHSS and the syndromes of Traditonal Chinese Medicine of the test group and controlled group were significantly different(P<0.05) indicating that the yangyintongnao granule and the xiaoshuantong granule can improve the neurologic impairment and the symptoms. 2.The contrast between the evaluation of comprehensive effect between the treated group and control group after the fourth week was significantly different, indicating that the effect of yangyintongmai granule to treat dysneuria and improve syndrome was superior to that of xiaoshuantong granule.The result of High-dose group was better than that of Low-dose group (P <0.0167).3.The difference of blood rheology and coagulation index between the treated group and control group was not significant(P>0.05).4.Safety assessment:The safety indexes of before and after the treatment were not significantly different (P>0.05).5. Evaluation of adverse reactions:Patients in each group had no significant adverse reactions.Conclusion:Yangyintongnao granule is an effective and safe drug in treating Convalescent apoplexy(deficiency of qiyin and blood stasis syndrome).The therapeutic effect of it is superior to that of xiaoshuantong granule. The recommended dose is:1 package one time,3 times one day.Stageâ…¢clinical trials are necessary to evaluate the therapeutic effect and safety of Yangyintongnao granule. |
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