Abstract: OBJECTIVE To investigate into the effect and safety of Tonglong Capsule in the treatment of hyperplasia of prostate.METHOD 90 patients were randomly divided into a treatment group of 60 patients and a control group of 30 patients,who took Tonglong Capsule and Qianliekang tablet respectively for 90 days.RESULT Marked differences were found between the two groups in IPSS decrease rating,maximum urine flow increase and residual urine volume decrease(P<0.01),and also in prostate volume reduction(P<0.05).The result of sex hormone determination indicated that in the group with prostate volume reduction,E_2 and E_2/T ratio decreased,with marked difference as compared with the group without prostate volume reduction(P<0.05).No serious undesirable accident occurred in both group.CONCLUSION Tonglong Capsule is very effective for hyperplasia of prostate,with no serious side effect.