Objective:To investigate the clinical efficacy and safety of compound bismuth potassium citrate capsules(CBPCC) combined with omeprazole capsules in eradication of Helicobacter pylori(H.pylori) infection.Methods: A total of 240 patients with gastric H.pylori infection were enrolled in this double-blinded,randomized controlled study.Patients in group A(control group) were given a combination of bismuth potassium citrate/tinidazole/clarithromycin tablets and ormprazole capsule (n=120); those in group B(treatment group) were given compound bismuth potassium citrate capsules and ormprazole capsules(n=120).H.pylori eradication rates and clinical safety of both treatment regimens were analyzed using SAS 6.12 software system. Results: A total of 236 patients from 6 resreach centers completed in this study,with 117 in group A and 119 in group B.Two patients in the contol group and 8 in the treatment group did not complete the experiment; six patients in the control group were excluded due to other reasons.There were 236 patients entered full analysis sets(FAS),220 entered per-protocol set(PPS),and 236 entered safety analysis sets(SS).FAS showed that the eradication rates of H.pylori were 84.87% in group B and 74.36% in group A(P<0.05); PPS showed the eradication rates were 76.15% in group A and 90.09% in group B(P<0.05).Intragroup comparison showed that the symptoms of patients in both groups were effectively improved; intergroup comparison showed that the symptom improvement rates were similar between the 2 groups.The rates of adverse events were 14.53% in group A and 14.29% in group B(P>0.05), with no severe adverse event found in both groups.The treatment regimen in group B was more cost-effective than that in group A(P＜0.05).Conclusion：This study demonstrates that compound bismuth potassium citrate capsules combined with omeprazole capsules have a high efficacy in eradication of H.pylori infection,and it is safe,cost-effective and worth popularizing in clinic.