Objective To assess the effectiveness and safety of Fushenqudu capsules in the treatment of chronic renal failure. Methods The double blind, double dummy and randomized controlled method was adopted. One hundred and thirty one patients were randomized to the trial group (n=88, Fushenqudu capsule, 4 capsules, qid) and the control group (n =43, Shenshuaining capsules, 4 capsules, qid). The therapeutic duration for both groups was 8 weeks. Results The results were analyzed on the basis of intention-to-treat. For effectiveness of treatment, the markedly effective rate was 27.3% (24/88); the total effective rate was 67.0% (59/88) in the treatment group; the markedly effective rate was 25.6% (11/43), the total effective rate was 58.1% (25/43) in the control group. There was no statistical difference between the two groups (Pgt;0.05). For effectiveness of Pishenqixu syndrome, the markedly effective rate was 48.9% (43/88) and 53.3% (23/43) respectively in the trial and control groups. No statistically significant difference was tested between the two groups (Pgt;0.05). Mild adverse effects occurred in two groups. When a smaller dose or termination of the drug were applied, the symptoms went. The tolerance was good when the patients took the medicine regularly. Conclusions Fushenqudu capsules have the same clinical effect as Shenshuaining capsule with a little toxic adverse effects.