200Case Clinical Trial Of Additives Buhuanjing Zhengqisan Capsule In Therapy Of Infectious Diarrhea(Dampness Obstructing Spleen-stomach Syndrome)

Objective:To evaluate the clinical effect and security of Additives Buhuanjing Zhengqisan Capsule in treating infectious diarrhea(dampness obstructing spleen-stomach syndrome).Methods:Select200cases who suffer from infectious diarrhea(dampness obstructing spleen-stomach syndrome) following randomization,double-blindness, placebo controlled clinical trial. They were divided into150cases in test group,50cases in the control group. Experimental group was given Additives Buhuanjing Zhengqisan capsules4/time,3times/day; placebo control group,4/time,3times/day. Three days for a course. The patients’ blood, blood biochemistry, urine routine, ECG, liver and renal function were tested before and after the treatment, And TCM syndromes in patients with signs, to keep records of the adverse events. Comprehensive analysis of the above indicators of drug safety and effectiveness trials to evaluate.Results:1Curative effect evaliation(1) Main index:The results were significantly different in stool frequency for different time points before and after treatment (P<0.001). The improving grades of the stool frequency had significant difference between the two groups at each time point of the treatment(P<0.05). The stool characters had significant difference between different time points of the treatment within each group(P<0.001).The improving grades of the stool characters during the treatment had significant difference at each time point of the treatment(P<0.05). Determine the efficacy of the disease, the test group and the control group with a significant difference (P<0.001), combined with remarkable efficiency, efficient judge the efficacy of the test group better than the control group. (2) Secondary efficacy indexesThere were significant differences between before treatment and after treatment within the two groups in the total symptom score,the main symptom score and the secondary symptom score (P<0.001). There was Statistical significance in the symptomatic efficacy evaluation,the main disease curative effect evaluation and the secondary symptoms curative effect evaluation(P<0.05).There were significant differences between the two groups in diarrhea onset time and Fecal recovery time (P<0.001).Each simple symptom comparison:There were significant differences within each group in urgent diarrhea, diarrhea unhappy, abdominal distention and bellyache, treatment group more effective than control group.But in poor appetite, nausea and tongue control group more effective than treatment group.2The security evaluationDuring the whole course of the test,there weir no obvoiously bad affair happened.The drug which in the test has good security.Conclusion:Additives Buhuanjing Zhengqisan Capsule could improve infective diarrhea(spleen-stomach syndrome) cases’ clinical symptoms obviously.The therapeutic effect was exact with no obvious adverse reaction,which showed that this medicine was effective and safe generally with clinical value.