Multi-center Clinical Trial For Treating Common Cold Of Wind-heat And Accumulate Inside Syndrome With Gedai Granules

Objective:To evaluate the safety and effect of Gedai granules in treating common coldMethods:Design:Regional group randomized,double-blind,parallel positive drug control, multi-center clinical trial. Drug function:Qingre of the table,Tongli Xiere;Indications:common cold of Wind-heat and accumulate inside syndromeSelected criteria:With Cold modern medical diagnosis And common cold of Wind-heat and accumulate inside syndromeTest:FAS-442 cases,331 cases of the test group and 111 cases of the control group,PP set440 cases,330 cases of the test group,110 cases of the control group.Regimen:Experimental Medicine:Gedai granules;control drugs:anti-flu antidote granules, 5g/bag,two bags/time,3times/day,3days/treatment.Outcome measures:①flu signs:temperature,pharyngeal mucosa congestive②Chinese indicators:fever and cold-blooded,pharyngodynia as red,etc.Clinical indicators:①Clinical②Clinical Syndrome③Onset,Cooling time.Security indicators:①adverse reaction;②vital signs;③blood,urine,conventional of stool, function of liver and renal,electrocardiogram.Statistical Methods:ANOVA,rank sum test,paired t,chi-square test,covariance,CMH, repeated measurementResults:Baseline:The difference between the two groups was not statistically significant(P＞0.05),in the demographic data,duration,clinical total score and Syndrome score,temperature,baseline data were comparable balanced.Effect:The difference between the two groups is statistically significant P＜0.05,in clinical efficacy,in Syndrome effect and in temperature.The effect of Gedai Granules was better than the Anti-flu antidote Granules'.Covariance analysis was made by the baseline of clinical total score or syndrome score,the difference between the two groups was significant in baseline and groups P＜0.05.Covariance analysis showed that:clinical total score and syndrome score impacted Clinical effect P＜0.05,less score maked good effect.By repeated measurement analysis of variance,the result of dynamic changes of temperature was that Gedai granules' temperature can be reduced effectively,it was better than the control group P＜0.05.In the Gedal granules group, the average time of onset was 3.392 hours,the cooling time was 22.623 hours.There were no drug-related adverse events or adverse reactions in the two groups;The vital signs,physical and chemical laboratory examination were within normal range.Conclusions:Gedai Granule is safe and effective in treating common cold what Wind-heat and accumulate inside.