Clinical Trial Study Of Gout Capsule In The Treatment And Safety Of Acute Gouty Arthritis(Damp-heat Retention Syndrome)

Objective:By observing the effect of Gout Capsule in treating damp-heat syndrome gouty arthritis clinical,and trial to evaluate the efficacy and the safety.Methods:This research consisted of random,double-blinded,placebo-controlled and polycentric clinical trials.The ratio of experimental group and control group is three to one.There are 96 patients who met the criteria for gouty arthritis,including of 72 experimental groups and 24 control groups.During the observation,the experimental groups treated with Gout Capsule,while the control groups treated with placebo in 3 days.The researchers permission when necessary,can be used in accordance with voltaren.This research recorded the data of TCM syndrome score,erythrocyte sedimentation rate(ESR),C-reactive protein,liver function,kidney function,blood routine,urine routine,fecal routine and ECG between before and after treatment in both groups to evaluate the safety of Gout capsule through statistical analysis.Results:1.The present study included 96 patients with gout,finished 90 cases,including 68 cases of experimental group and 22 cases of control group,and depigmented 5 cases,rejected 1 cases.2.There's a notable improvement in TCM syndrome score and VAS after treatment compared with pre-treatment(P<0.05),the improvement of experimental groups are superior to control groups(P<0.05).And the TCM symptom curative effect of experimental groups are superior to control groups(P<0.05).The improvement of TCM syndrome score and VAS,the TCM symptom curative effect of experimental groups are still superior to control groups while exclude drug(voltaren)combination(P<0.05).3.The white blood cells,ESR and CRP of both the two groups were no significant different after the treatment(P>0.05).4.There's no significant of difference in liver function(ALT,AST)and renal function(Bun,Cr)after treatment(P>0.05).There's no significantly difference in adverse event of both the two groups(P>0.05).Conclusions:Gout Capsule in treating damp-heat syndrome gouty arthritis is better than placebo,it can improve the TCM syndrome,and relieve the pain of arthrosis,and it is safe as placebo.