Method of Yiqi Huoxue Huazhuo Jiedu in the treatment of cerebral ischemic stroke:A multicenter double-blind randomized controlled trial
Objective:To observe the clinical efficacy,safety and recurrence rate of the method of Yiqi Huoxue Huazhuo Jiedu(YHHJ)in the treatment of cerebral ischemic stroke(CIS).Methods:A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.A total of 120 patients with CIS were randomly divided into two groups,during the research process,there were cases of dropouts,53 cases in the control group and 56 cases in the treatment group,finally.The control group was given Chinese medicine granule simulants orally,while the treatment group was given Chinese medicine granule with the efficacy of YHHJ orally.The National Institutes of Health Stroke Scale(NIHSS),traditional Chinese medicine(TCM)syndrome score,high-sensitivity C-reactive protein(hs-CRP)and blood homocysteine(Hcy)in the two groups were observed before treatment,on the 21st day,3rd month and 6th month after treatment.Blood lipid in the two groups were observed before treatment and 6th month after treatment.Both groups were followed up for 12 months to observe the recurrence of cerebrovascular disease.Results:On the 21st day,3rd month and 6th month after treatment,the NIHSS scores,TCM syndrome scores,hs-CRP and Hcy of the two groups were significantly lower than those before treatment(P＜0.05).At the 3rd month and 6th month after treatment,the above indexes in the treatment group was significantly lowered than those in the control group(P＜0.05).At the 6th month after treatment,the levels of blood lipids in the two groups were lower than those before treatment(P＜0.05),and the treatment group was significantly lowered than the control group significantly(P＜0.05).After 12 months of follow-up,the recurrence rate was 1.8％(1/56)in the treatment group,while the recurrence rate was 5.7％(3/53)in the control group,there was no statistical significance.Conclusion:The method of YHHJ can significantly reduce NIHSS scores,improve TCM symptoms,lower inflammatory response,reduce Hcy and blood lipid for improving clinical efficacy in CIS patients.It causes no significant adverse effects.
Method of Yiqi Huoxue Huazhuo JieduCerebral ischemic stroke(CIS)Qi deficiency and blood stasisTurbidity toxin in the interiorEfficacy observationStroke
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