| ObjectiveTo assess the clinical effect and security of Huangqin Zhengqi Capsule(HZC)for the treatment of infectious diarrhea(dampness obstructing spleen-stomach syndrome);To explore the effective dose of HZC for the treatment of infectious diarrhea(dampness obstructing spleen-stomach syndrome).MethodsAdopting the multicenter clinical trial which was center stratified,blocked randomized,double-blind,placebo controlled.According to the provisions of phase II clinical trial,240 cases including inpatient and outpatient cases were enrolled up to the standard of infectious diarrhea and dampness obstructing spleen-stomach syndrome from five sites.According to the principle of 1:1 distribution between the treatment group and the control group,High-dosage group,Low-dosage group and Placebo group respectively enrolled 80 cases.The respective treatment was:High-dosage group,4 HZC one time,3 times one day;Low-dosage Group,2 HZC and 2 simulant agents one time,3 times one day;Placebo Group,4 simulant agents one time,3 times one day,every group with the basic treatment:Oral rehydration salts 14.75g(meltwater500-1000ml),3 times one day,the whole treatment was double-blinded with the course of 3 days time.Stool bacteria culture was performed before the therapy,in the same time,blood,urine,stool,liver and kidney function and electrocardiogram normal regulations were carried on before and after the therapy.Record adverse reactions at any time of the treatment and observe the clinical symptoms,signs during the therapy.Assess all the above indexes to compare the effectiveness and security of the three groups and to explore the optimal dosage.Results1 The completing situations of the trial and the baseline indexes evaluation240 cases were enrolled in HZC clinical trial,of which 233 cases were qualified.Low-dosage Group enrolled 80 cases,finished 78 cases with 1 case shedding and 1 case excluded.High-dosage Group enrolled 80 cases,finished 78 cases with 1 case shedding and 1 case excluded.Control Group finished 77 cases with no case shedding and 3 cases excluded.The finishing ratio of the test is 97.18%.The baseline indexes of the three groups were equilibrium and comparable in seismically.2 The main evaluating indicators evaluationThere was a significant difference in the stool frequency between different time points during the treatment each group(P<0.001).The improving grades of the stool frequency had no significant difference between High-dosage Group and Low-dosage Group at each time point of the treatment.(P>0.17),but had significant difference between Placebo Group and Low-dosage Group(P<0.001).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 between High-dosage Group and Low-dosage Group at each time point of the treatment(P>0.08),but had significant difference between Placebo Group and Low-dosage Group(P<0.001).General efficacy determined,there was a significant difference between the three groups after 4days’ treatment(P<0.001),There was no significant difference between High-dosage Group and Low-dosage Group,but there was a significant difference between Placebo Group and Low-dosage Group.It showed that in the improvement of these symptoms,the treatment groups were better comparing to Control group.3 The secondary efficacy indexes evaluationThere were significant differences between before treatment and after treatment within the three groups in the total symptom score,the main symptom score and the secondary symptom score(P<0.001).Multiple comparison showed:there were significant differences between High-dosage Group,Low-dosage Group and Placebo group(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 was a significant difference between High-dosage Group and Low-dosage Group too.All the above results showed that the treatment groups both could improve the infectious diarrhea symptoms,better than Control Group.There were significant differences between the three groups in diarrhea onset time and Fecal recovery time,and there were significant differences between Placebo Group and High-dosage Group,as well as Placebo Group and Low-dosage Group(P<0.001).Each simple symptom comparison:There were significant differences within each group after 2 and 4 days’ treatment in urgent diarrhea and diarrhea with sensation of incomplete defecation.There were significant differences between the three groups according to chi-square test(P<0.001),but no significant difference by binary logistic regression analysis considering factors of the symptom before the treatment and the sites(P=0.329/0.965).Each simple symptom comparison indicated that the test groups had no advantage in improving poor appetite symptom,but had advantage in improving the symptoms of nausea and vomiting abdominal distension,abdominal pain and borborygmus comparing to Control group.4 The security evaluationThe liver and renal function,blood,stool and urine routine were observed and compared in the trail.One case of HZC’s Low-dosage Group was slightly elevated ALT,one case of HZC’s High-dosage Group had slight renal dysfunction,which was considered could attribute to the medication.5 Dose explorationThe exploration of the low and high dosage was performed in this trial,the result showed:the two test groups’ effect was similar,both better than Control group.But according to the statistics representation of Low-dosage and High-dosage Groups,High-dosage Group was a little better,moreover,the onset time of High-dosage Group was better than Low-dosage Group too,and there was no significant difference in security characters between the two dosage groups.ConclusionHuangqin Zhengqi Capsule could improve infective diarrhea(spleen-stomach syndrome)cases’ clinical symptoms and signs obviously.The therapeutic effect was exact with no obvious adverse reaction,which showed that this medicine was effective and safe generally.But whether it really had hepatotoxicity and nephrotoxicity need phase III clinical trial enlarging the sample size to verify further. |
PDF Full Text Request