Tangjiangshenkang granule in treatment of diabetic nephropathy:a doubleblind,randomized,placebo-controlled multicentre clinical trial

AIM To evaluate the safety and efficacy of Tangjiangshenkang granule in the treatment of diabetic nephropathy(DN).METHODS This study was a multicentre,double-blind,double-dummy, randomized and parallel placebo controlled clinical trial.Based on basic treatment,eligible patients were administered orally with low dose(one pack of Tangjiangshenkang granule and one pack of placebo,tid),high dose(two packs of Tangjiangshenkang granule,bid,and two packs of placebo,qd) and placebo(two packs of placebo,tid) for 8 weeks.The urinary albumin excretion rate(UAER),24 h quantitative examination of urinary protein(UPQ) and fasting plasma glucose were measured respectively before the treatment,4 and 8 weeks after the administration.RESULTS One hundred and ninety-four stageⅢorⅣDN patients participated in the trials.Excluding 10 patients,the per-protocol set was 184 patients.The clinical control rates were 47%, 42%and 18%in the high dose group,low dose group and control group,respectively.The treatment effectiveness of patients with low or high dose Tangjiangshenkang granule was better than those with placebo(P0.05).There were no significantly differences between the high dose and low dose groups in clinical efficacy (P0.05).After the treatment,the UAER was(83±157),(212±612) and(298±783)μg·min~(-1), the UPQ was(477±427),(675±856) and(812±1 318) mg in the high dose group,low dose group and control group,respectively.UAER and UPQ in the high and low dose groups were significantly higher than those in the control group(P0.05).No serious adverse reaction occurred in all groups.CONCLUSION Tangjiangshenkang granule is effective and safe in the treatment of DN.