The Clinical Observation Of Tribulus Terrestris Saponins Capsules In The Treatment Of Cerebral Infarction (the Meridian In Stroke Disease) During The Recovery Period (wind Phlegm And Blood Stasis Syndrome

Objective:To evaluate the efficacy and safety of gross saponins of Tribulus terrestris(GSTT)capsule in the treatment of cerebral infarction(apoplexy involving meridians and collaterals)in the recovery period(wind phlegm stasis syndrome),and to observe the possible adverse reactions,through clinical randomized controlled trials.Methods:According to the method of clinical epidemiological study,60 cases of cerebral infarction(apoplexy involving meridians and collaterals)in the recovery period(wind phlegm stasis syndrome)meeting the inclusion criteria were recruited and observed,using randomized controlled trial.60 patients were randomly divided into the treatment group and the control group equally.The control group was treated with the secondary prevention therapy.The treatment group was treated with GSTT capsule besides the secondary prevention treatment.Both groups were treated for 28 days.Before treatment,28 days after treatment and 180 days after the onset of the disease,the Modified Rankin Scale(MRS),the Activities of Daily Living(Barthel-Index),the National Institutes of Health Stroke Scale score(NIHSS)and the TCM single syndrome scores were recorded.After analysis of scores of these scales with statistical methods,the efficacy was evaluated by the comparison between the groups,and before and after the treatments within the groups.Adverse events were recorded and calculate the incidence of adverse reactions.Results:After enrollment,the treatment group dropped 2 cases,so 28 cases in the treatment group and 30 cases in the control group were analyzed and processed with statistical methods for MRS,Barthel index,NIHSS and TCM single syndrome scores.Results of intra-group comparison:The results of intra-group comparisons of patients in the treatment group at various time points and scores were all P<0.05,which was statistically different.In the control group before treatment and 28 days after treatment,there was no statistical difference in the scores of three symptoms of lower limbs paralysis,facial paralysis and excessive sputum,P>0.05,and all other time points and scores were P<0.05,which was of statistically significant difference.Results of comparison between the groups:After 28 days of treatment,the scores of the two groups of patients were compared between groups.Results:The two symptom scores of speech disorder and excessive phlegm were P>0.05,which was not statistically significant.The other scores were all P<0.05,of statistical significance.The results of comparison between the two groups after 180 days of onset:P>0.05 for symptoms such as facial paralysis,numbness of the body,dizziness,speech disorder,and excessive sputum,which were not statistically significant.The other scores were P<0.05,statistically significant.During the course of treatment,no adverse reactions occurred in the treatment group.There were no clinically significant changes in safety indicators such as vital signs,blood routine,urine routine,stool routine(+occult blood),blood coagulation,liver function,renal function,12-lead electrocardiogram,etc.Conclusion:This trial has preliminarily proved the efficacy of GSTT capsule on the recovery stage of cerebral infarction.It plays an important role in ameliorating patients’ nerve function defect,recovering patients’ limb function and improving patients’ ability of daily life.It can effectively reduce the major TCM symptoms,greatly reduce the pain of patients,improve the living quality and lighten family burden of patients.At the same time,no obvious adverse reactions were found during the experiment,so the drug is of high safety.